General Commentaries, Perspectives and Reviews Virtual Issue

  • Industry Perspective on Contemporary Protein-Binding Methodologies: Considerations for Regulatory Drug-Drug Interaction and Related Guidelines on Highly Bound Drugs

    Li Di, Christopher Breen, Rob Chambers, Sean T. Eckley, Robert Fricke, Avijit Ghosh, Paul Harradine, J. Cory Kalvass, Stacy Ho, Caroline A. Lee, Punit Marathe, Everett J. Perkins, Mark Qian, Susanna Tse, Zhengyin Yan, Maciej J. Zamek-Gliszczynski
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 12, p3442–3452
  • Parameters Affecting the Enhanced Permeability and Retention Effect: The Need for Patient Selection

    Az Alddien Natfji, Divyashree Ravishankar, Helen M.I. Osborn, Francesca Greco
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 11, p3179–3187
  • Drug Delivery Innovations to Address Global Health Challenges for Pediatric and Geriatric Populations (Through Improvements in Patient Compliance)

    Joshua Boateng
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 11, p3188–3198
  • Perspectives on Subcutaneous Route of Administration as an Immunogenicity Risk Factor for Therapeutic Proteins

    Lora Hamuro, Grzegorz Kijanka, Francis Kinderman, Harald Kropshofer, De-xiu Bu, Monica Zepeda, Vibha Jawa
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 10, p2946–2954
  • Current Progress Toward a Better Understanding of Drug Disposition Within the Lungs: Summary Proceedings of the First Workshop on Drug Transporters in the Lungs

    Carsten Ehrhardt, Per Bäckman, William Couet, Chris Edwards, Ben Forbes, Markus Fridén, Mark Gumbleton, Ken-Ichi Hosoya, Yukio Kato, Takeo Nakanishi, Mikihisa Takano, Tetsuya Terasaki, Ryoko Yumoto
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2234–2244
  • Transporters Involved in Metformin Pharmacokinetics and Treatment Response

    Xiaomin Liang, Kathleen M. Giacomini
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2245–2250
  • Evaluation of New Chemical Entities as Substrates of Liver Transporters in the Pharmaceutical Industry: Response to Regulatory Requirements and Future Steps

    Noriko Okudaira
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2251–2256
  • A Critical View on In Vitro Analysis of P-glycoprotein (P-gp) Transport Kinetics

    Lasse Saaby, Birger Brodin
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2257–2264
  • Pharmacokinetics of Exosomes—An Important Factor for Elucidating the Biological Roles of Exosomes and for the Development of Exosome-Based Therapeutics

    Masaki Morishita, Yuki Takahashi, Makiya Nishikawa, Yoshinobu Takakura
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2265–2269
  • Physiologically Based Pharmacokinetic Modeling of Therapeutic Proteins

    Harvey Wong, Timothy W. Chow
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2270–2275
  • Do We Need to Study Metabolism and Distribution in the Eye: Why, When, and Are We There Yet?

    Upendra A. Argikar, Jennifer L. Dumouchel, Valerie M. Kramlinger, Amanda L. Cirello, Mithat Gunduz, Christine E. Dunne, Bindi Sohal
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2276–2281
  • Effect of Liver Disease on Hepatic Transporter Expression and Function

    Nilay Thakkar, Jason R. Slizgi, Kim L.R. Brouwer
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2282–2294
  • Model Systems for Studying the Role of Canalicular Efflux Transporters in Drug-Induced Cholestatic Liver Disease

    Bruno Stieger, Zainab M. Mahdi
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2295–2301
  • Recent Progress in Hepatocyte Culture Models and Their Application to the Assessment of Drug Metabolism, Transport, and Toxicity in Drug Discovery: The Value of Tissue Engineering for the Successful Development of a Microphysiological System

    Kazuhiro Tetsuka, Masato Ohbuchi, Kenji Tabata
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2302–2311
  • Intestinal Drug Interactions Mediated by OATPs: A Systematic Review of Preclinical and Clinical Findings

    Jingjing Yu, Zhu Zhou, Jessica Tay-Sontheimer, René H. Levy, Isabelle Ragueneau-Majlessi
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2312–2325
  • Routes for Drug Translocation Across the Blood-Brain Barrier: Exploiting Peptides as Delivery Vectors

    Mie Kristensen, Birger Brodin
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2326–2334
  • Imaging Probes and Modalities for the Study of Solute Carrier O (SLCO)-Transport Function In Vivo

    Solène Marie, Salvatore Cisternino, Irène Buvat, Xavier Declèves, Nicolas Tournier
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2335–2344
  • Possibility of Predicting Serotonin Transporter Occupancy From the In Vitro Inhibition Constant for Serotonin Transporter, the Clinically Relevant Plasma Concentration of Unbound Drugs, and Their Profiles for Substrates of Transporters

    Masahiro Yahata, Koji Chiba, Takao Watanabe, Yuichi Sugiyama
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2345–2356
  • Identification of Endogenous Biomarkers to Predict the Propensity of Drug Candidates to Cause Hepatic or Renal Transporter-Mediated Drug-Drug Interactions

    Xiaoyan Chu, Grace Hoyee Chan, Raymond Evers
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2357–2367
  • Clinical Implementation of Pharmacogenomics for Personalized Precision Medicine: Barriers and Solutions

    Michelle E. Klein, Md Masud Parvez, Jae-Gook Shin
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2368–2379
  • Usefulness of PBPK Modeling in Incorporation of Clinical Conditions in Personalized Medicine

    Niloufar Marsousi, Jules A. Desmeules, Serge Rudaz, Youssef Daali
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2380–2391
  • The Use of Hemoglobin Vesicles for Delivering Medicinal Gas for the Treatment of Intractable Disorders

    Kazuaki Taguchi, Keishi Yamasaki, Hiromi Sakai, Toru Maruyama, Masaki Otagiri
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2392–2400
  • Professor Yuichi Sugiyama: A Brilliant, Creative, Amicable, Charming, and Humorous Pharmaceutical Scientist

    Hiroyuki Kusuhara, R. Scott Obach, Amin Rostami-Hodjegan, K. Sandy Pang, Margareta Hammarlund-Udenaes, Hartmut Derendorf, Per Artursson, Shiew-Mei Huang, Hiroshi Suzuki, Tetsuya Terasaki
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 9, p2188–2194
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril

    Roger K. Verbeeck, Isadore Kanfer, Raimar Löbenberg, Bertil Abrahamsson, Rodrigo Cristofoletti, D.W. Groot, Peter Langguth, James E. Polli, Alan Parr, Vinod P. Shah, Mehul Mehta, Jennifer B. Dressman
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 8, p1933–1943
  • Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations

    Ariadna Martos, Wendelin Koch, Wim Jiskoot, Klaus Wuchner, Gerhard Winter, Wolfgang Friess, Andrea Hawe
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 7, p1722–1735
  • Recent Update on Nanoemulgel as Topical Drug Delivery System

    Hira Choudhury, Bapi Gorain, Manisha Pandey, Lipika Alok Chatterjee, Pinaki Sengupta, Arindam Das, Nagashekhara Molugulu, Prashant Kesharwani
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 7, p1736–1751
  • Gelatin and Non-Gelatin Capsule Dosage Forms

    Rampurna P. Gullapalli, Carolyn L. Mazzitelli
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 6, p1453–1465
  • Optimizing Oral Bioavailability in Drug Discovery: An Overview of Design and Testing Strategies and Formulation Options

    Bruce J. Aungst
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 4, p921–929
  • Control Strategies for Drug Product Continuous Direct Compression—State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products

    Ahmad Almaya, Lawrence De Belder, Robert Meyer, Karthik Nagapudi, Hung-Ren Homer Lin, Ian Leavesley, Jayanthy Jayanth, Gurjit Bajwa, James DiNunzio, Anthony Tantuccio, Dan Blackwood, Admassu Abebe
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 4, p930–943
  • A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules

    Stephan Laske, Amrit Paudel, Otto Scheibelhofer and the Author Team
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 3, p667–712
  • Role of Buffers in Protein Formulations

    Teddy J. Zbacnik, Ryan E. Holcomb, Derrick S. Katayama, Brian M. Murphy, Robert W. Payne, Richard C. Coccaro, Gabriel J. Evans, James E. Matsuura, Charles S. Henry, Mark Cornell Manning
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 3, p713–733
  • Recent Advances in Lipid-Based Vesicles and Particulate Carriers for Topical and Transdermal Application

    Shashank Jain, Niketkumar Patel, Mansi K. Shah, Pinak Khatri, Namrata Vora
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 2, p423–445
  • If Euhydric and Isotonic Do Not Work, What Are Acceptable pH and Osmolality for Parenteral Drug Dosage Forms?

    Dieter Roethlisberger, Hanns-Christian Mahler, Ulrike Altenburger, Astrid Pappenberger
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 2, p446–456
  • Using X-Ray Crystallography to Simplify and Accelerate Biologics Drug Development

    Mark L. Brader, Edward N. Baker, Michael F. Dunn, Thomas M. Laue, John F. Carpenter
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 2, p477–494
  • Professor Peter York—A Distinguished Career in Powders, Processing, and Particle Design

    Lynne S. Taylor, Jukka Rantanen, Anant Paradkar, Yoshiaki Kawashima, Jiwen Zhang
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 1, p2–4
  • Interrelationships Between Structure and the Properties of Amorphous Solids of Pharmaceutical Interest

    George Zografi, Ann Newman
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 1, p5–27
  • Predicting the Crystallization Propensity of Drug-Like Molecules

    Bruno C. Hancock
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 1, p28–30
  • Mitigating Cocrystal Physical Stability Liabilities in Preclinical Formulations

    Sunny Bhardwaj, Maya Lipert, Annette Bak
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 1, p31–38
  • Pharmaceutical Amorphous Nanoparticles

    Rajan Jog, Diane J. Burgess
    Journal of Pharmaceutical Sciences, Vol. 106, Issue 1, p39–65
  • Technical Decision Making With Higher Order Structure Data: Perspectives on Higher Order Structure Characterization From the Biopharmaceutical Industry

    William F. Weiss IV, John P. Gabrielson, Wasfi Al-Azzam, Guodong Chen, Darryl L. Davis, Tapan K. Das, David B. Hayes, Damian Houde, Satish K. Singh
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 12, p3465–3470
  • The Density Code for the Development of a Vaccine?

    Wei Cheng
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 11, p3223–3232
  • Microdialysis of Large Molecules

    Satyawan B. Jadhav, Vipada Khaowroongrueng, Hartmut Derendorf
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 11, p3233–3242
  • New and Evolving Techniques for the Characterization of Peptide Therapeutics

    Suzanne M. D'Addio, Jameson R. Bothe, Claudia Neri, Paul L. Walsh, Jingtao Zhang, Elizabeth Pierson, Yun Mao, Marian Gindy, Anthony Leone, Allen C. Templeton
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 10, p2989–3006
  • Trends in the Assessment of Drug Supersaturation and Precipitation In Vitro Using Lipid-Based Delivery Systems

    Cordula Stillhart, Martin Kuentz
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2468–2476
  • Non-Sink Dissolution Conditions for Predicting Product Quality and In Vivo Performance of Supersaturating Drug Delivery Systems

    Dajun D. Sun, Hong Wen, Lynne S. Taylor
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2477–2488
  • Amorphous Solid Dispersions or Prodrugs: Complementary Strategies to Increase Drug Absorption

    Alfred C.F. Rumondor, Sundeep S. Dhareshwar, Filippos Kesisoglou
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2498–2508
  • Ciclesonide: A Pro-Soft Drug Approach for Mitigation of Side Effects of Inhaled Corticosteroids

    Jatinder Kaur Mukker, Ravi Shankar Prasad Singh, Hartmut Derendorf
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2509–2514
  • A Minireview: Usefulness of Transporter-Targeted Prodrugs in Enhancing Membrane Permeability

    Teruo Murakami
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2515–2526
  • Polymeric Amorphous Solid Dispersions: A Review of Amorphization, Crystallization, Stabilization, Solid-State Characterization, and Aqueous Solubilization of Biopharmaceutical Classification System Class II Drugs

    Shrawan Baghel, Helen Cathcart, Niall J. O'Reilly
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2527–2544
  • Review of Disintegrants and the Disintegration Phenomena

    Parind Mahendrakumar Desai, Celine Valeria Liew, Paul Wan Sia Heng
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2545–2555
  • Self-Assembly of Cyclodextrins and Their Complexes in Aqueous Solutions

    Alexey Ryzhakov, Thao Do Thi, Jef Stappaerts, Laura Bertoletti, Kristof Kimpe, André Rodrigues Sá Couto, Phennapha Saokham, Guy Van den Mooter, Patrick Augustijns, Govert W. Somsen, Sergey Kurkov, Sabine Inghelbrecht, Albertina Arien, M. Ilias Jimidar, Koen Schrijnemakers, Thorsteinn Loftsson
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2556–2569
  • Cyclodextrin-Mediated Hierarchical Self-Assembly and Its Potential in Drug Delivery Applications

    Iurii Antoniuk, Catherine Amiel
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2570–2588
  • Brain-Targeting Chemical Delivery Systems and Their Cyclodextrin-Based Formulations in Light of the Contributions of Marcus E. Brewster

    Peter Buchwald, Nicholas Bodor
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2589–2600
  • Pharmaceutical Applications of Electrospraying

    Duong Nhat Nguyen, Christian Clasen, Guy Van den Mooter
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 9, p2601–2620
  • Subcutaneous Injection Volume of Biopharmaceuticals—Pushing the Boundaries

    Roman Mathaes, Atanas Koulov, Susanne Joerg, Hanns-Christian Mahler
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 8, p2255–2259
  • Support Tools in Formulation Development for Poorly Soluble Drugs

    Gudrun A. Fridgeirsdottir, Robert Harris, Peter M. Fischer, Clive J. Roberts
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 8, p2260–2269
  • Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan

    Ryosuke Kuribayashi, Tomoko Takishita, Kenichi Mikami
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 8, p2270–2277
  • Subcutaneous Injection Volume of Biopharmaceuticals—Pushing the Boundaries

    Roman Mathaes, Atanas Koulov, Susanne Joerg, Hanns-Christian Mahler
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 8, p2255–2259
  • Support Tools in Formulation Development for Poorly Soluble Drugs

    Gudrun A. Fridgeirsdottir, Robert Harris, Peter M. Fischer, Clive J. Roberts
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 8, p2260–2269
  • Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan

    Ryosuke Kuribayashi, Tomoko Takishita, Kenichi Mikami
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 8, p2270–2277
  • An Overview of Pharmaceutical Excipients: Safe or Not Safe?

    Cátia G. Abrantes, Dinah Duarte, Catarina P. Reis
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 7, p2019–2026
  • Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges

    Wim Jiskoot, Grzegorz Kijanka, Theodore W. Randolph, John F. Carpenter, Atanas V. Koulov, Hanns-Christian Mahler, Marisa K. Joubert, Vibha Jawa, Linda O. Narhi
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 5, p1567–1575
  • Key Considerations in Designing Oral Drug Delivery Systems for Dogs

    Yunmei Song, Karl Peressin, Pooi Yin Wong, Stephen W. Page, Sanjay Garg
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 5, p1576–1585
  • Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug Products

    Leonardo Allain, Steven W. Baertschi, David Clapham, Chris Foti, Wendy M. Lantaff, Robert A. Reed, Allen C. Templeton, Hanne Hjorth Tønnesen
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 5, p1586–1594
  • On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs

    Alfredo García-Arieta, John Gordon, Henrike Potthast
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 4, p1353–1354
  • Reply to “On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs”

    Soundarya Vaithianathan, Sam H. Haidar, Xinyuan Zhang, Wenlei Jiang, Christopher Avon, Thomas C. Dowling, Changxing Shao, Maureen Kane, Stephen W. Hoag, Mark H. Flasar, Tricia Y. Ting, James E. Polli
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 4, p1355–1357
  • Bad Science: Cause and Consequence

    Steve Elliott
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 4, p1358–1361
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin

    Navid Goodarzi, Ahmadreza Barazesh Morgani, Bertil Abrahamsson, Rodrigo Cristofoletti, D.W. Groot, Peter Langguth, Mehul U. Mehta, James E. Polli, Vinod P. Shah, Jennifer B. Dressman
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 4, p1362–1369
  • A Tribute to Ronald T. Borchardt—Teacher, Mentor, Scientist, Colleague, Leader, Friend, and Family Man

    Katharine Barbara Schowen, Richard L. Schowen, Susan E. Borchardt, Paul M. Borchardt, Per Artursson, Kenneth L. Audus, Patrick Augustijns, Joseph A. Nicolazzo, Thomas J. Raub, Christian Schöneich, Teruna J. Siahaan, Yoshi Takakura, Dhiren R. Thakker, Michael S. Wolfe
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p370–385
  • Noncovalent PEGylation, An Innovative Subchapter in the Field of Protein Modification

    Christian Reichert, Gerrit Borchard
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p386–390
  • Physical and Chemical Stability of Antibody Drug Conjugates: Current Status

    Philip L. Ross, Janet L. Wolfe
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p391–397
  • Stroke and Drug Delivery—In Vitro Models of the Ischemic Blood-Brain Barrier

    Erica Tornabene, Birger Brodin
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p398–405
  • Toward Carbon Monoxide–Based Therapeutics: Critical Drug Delivery and Developability Issues

    Xingyue Ji, Krishna Damera, Yueqin Zheng, Bingchen Yu, Leo E. Otterbein, Binghe Wang
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p406–416
  • Immunogenicity of Therapeutic Protein Aggregates

    Ehab M. Moussa, Jainik P. Panchal, Balakrishnan S. Moorthy, Janice S. Blum, Marisa K. Joubert, Linda O. Narhi, Elizabeth M. Topp
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p417–430
  • Explication of Definitional Description and Empirical Use of Fraction of Orally Administered Drugs Absorbed From the Intestine (Fa) and Intestinal Availability (Fg): Effect of P-glycoprotein and CYP3A on Fa and Fg

    Yuta Tanaka, Yoshiaki Kitamura, Kazuya Maeda, Yuichi Sugiyama
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p431–442
  • Sandwich-Cultured Hepatocytes as a Tool to Study Drug Disposition and Drug-Induced Liver Injury

    Kyunghee Yang, Cen Guo, Jeffrey L. Woodhead, Robert L. St. Claire III, Paul B. Watkins, Scott Q. Siler, Brett A. Howell, Kim L.R. Brouwer
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p443–459
  • PEGylation of Biopharmaceuticals: A Review of Chemistry and Nonclinical Safety Information of Approved Drugs

    Peter L. Turecek, Mary J. Bossard, Freddy Schoetens, Inge A. Ivens
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p460–475
  • Literature Review of Gastrointestinal Physiology in the Elderly, in Pediatric Patients, and in Patients with Gastrointestinal Diseases

    Jane P.F. Bai, Gilbert J. Burckart, Andrew E. Mulberg
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p476–483
  • Why Does the Intestine Lack Basolateral Efflux Transporters for Cationic Compounds? A Provocative Hypothesis

    William R. Proctor, Xin Ming, David Bourdet, Tianxiang (Kevin) Han, Ruth S. Everett, Dhiren R. Thakker
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 2, p484–496
  • Technology, Applications, and Process Challenges of Dual Chamber Systems

    Tobias Werk, Imke S. Ludwig, Joerg Luemkemann, Hanns-Christian Mahler, Joerg Huwyler, Mathias Hafner
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 1, p4–9
  • A Review: Pharmaceutical and Pharmacokinetic Aspect of Nanocrystalline Suspensions

    Dhaval A. Shah, Sharad B. Murdande, Rutesh H. Dave
    Journal of Pharmaceutical Sciences, Vol. 105, Issue 1, p10–24
  • Advanced Therapeutic Dressings for Effective Wound Healing—A Review

    Joshua Boateng, Ovidio Catanzano
    Vol. 104, Issue 11, p3653–3680
  • Deliquescence: Hygroscopicity of Water-Soluble Crystalline Solids

    Anatoly G. Tereshchenko
    Vol. 104, Issue 11, p3639–3652
  • The Future of Pharmaceutical Manufacturing Sciences

    Jukka Rantanen, Johannes Khinast
    Vol. 104, Issue 11, p3612–3638
    Open Access
  • Scale Up of Pan Coating Process Using Quality by Design Principles

    Anjali M. Agrawal, Preetanshu Pandey
    Vol. 104, Issue 11, p3589–3611
  • Formulation Design of Dry Powders for Inhalation

    Jeffry G. Weers, Danforth P. Miller
    Vol. 104, Issue 10, p3259–3288
  • Amorphous Solid Dispersions: Utilization and Challenges in Drug Discovery and Development

    Yan He, Chris Ho
    Vol. 104, Issue 10, p3237–3258
  • Modernization of Physical Appearance and Solution Color Tests Using Quantitative Tristimulus Colorimetry: Advantages, Harmonization, and Validation Strategies

    Brian W. Pack, Laura L. Montgomery, Evan M. Hetrick
    Vol. 104, Issue 10, p3299–3313
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine

    Jayachandar Gajendran, Johannes Krämer, Vinod P. Shah, Peter Langguth, James Polli, Mehul Mehta, D.W. Groot, Rodrigo Cristofoletti, Bertil Abrahamsson, Jennifer B. Dressman
    Vol. 104, Issue 10, p3289–3298
  • Rate- and Extent-Limiting Factors of Oral Drug Absorption: Theory and Applications

    Kiyohiko Sugano, Katsuhide Terada
    Vol. 104, Issue 9, p2777–2788
  • Animal Farm: Considerations in Animal Gastrointestinal Physiology and Relevance to Drug Delivery in Humans

    Grace B. Hatton, Vipul Yadav, Abdul W. Basit, Hamid A. Merchant
    Vol. 104, Issue 9, p2747–2776
  • In Vitro Blood–Brain Barrier Models—An Overview of Established Models and New Microfluidic Approaches

    Anette Wolff, Maria Antfolk, Birger Brodin, Maria Tenje
    Vol. 104, Issue 9, p2727–2746
  • Direct In Vivo Human Intestinal Permeability (Peff) Determined with Different Clinical Perfusion and Intubation Methods

    David Dahlgren, Carl Roos, Erik Sjögren, Hans Lennernäs
    Vol. 104, Issue 9, p2702–2726
  • Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 2: Topical Drug Product

    Steven W. Baertschi, David Clapham, Chris Foti, Mark H. Kleinman, Solveig Kristensen, Robert A. Reed, Allen C. Templeton, Hanne Hjorth Tønnesen
    Vol. 104, Issue 9, p2688–2701
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam

    Marija Petruševska, Sandra Berglez, Igor Krisch, Igor Legen, Klara Megušar, Luka Peternel, Bertil Abrahamsson, Rodrigo Cristofoletti, D.W. Groot, Sabine Kopp, Peter Langguth, Mehul Mehta, James E. Polli, Vinod P. Shah, Jennifer Dressman
    Vol. 104, Issue 9, p2676–2687
  • Oral Solid Dosage Form Disintegration Testing — The Forgotten Test

    Jozef Al-Gousous, Peter Langguth
    Vol. 104, Issue 9, p2664–2675
  • Gordon L. Amidon: Very Sustained Drug Absorption

    Maureen D. Donovan, James E. Polli, Peter Langguth, Ikumi Tamai, Balvinder Vig, Lawrence X. Yu
    Vol. 104, Issue 9, p2650–2663
  • On the Biopharmaceutics Classification System Biowaiver of Ibuprofen

    Alfredo García-Arieta, John Gordon, Henrike Potthast
    Vol. 104, Issue 8, p2429–2432
  • Triggering Mechanisms of Thermosensitive Nanoparticles Under Hyperthermia Condition

    Ali Dabbagh, Basri Johan Jeet Abdullah, Hadijah Abdullah, Mohd Hamdi, Noor Hayaty Abu Kasim
    Vol. 104, Issue 8, p2414–2428
  • Quantifying Dry Milling in Pharmaceutical Processing: A Review on Experimental and Modeling Approaches

    Shivangi Naik, Bodhisattwa Chaudhuri
    Vol. 104, Issue 8, p2401–2413
  • Comparative Study of Analytical Techniques for Determining Protein Charge

    Dana I. Filoti, Steven J. Shire, Sandeep Yadav, Thomas M. Laue
    Vol. 104, Issue 7, p2123–2131
  • Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy

    Linda O. Narhi, Vincent Corvari, Dean C. Ripple, Nataliya Afonina, Irene Cecchini, Michael R. Defelippis, Patrick Garidel, Andrea Herre, Atanas V. Koulov, Tony Lubiniecki, Hanns-Christian Mahler, Paolo Mangiagalli, Douglas Nesta, Bernardo Perez-Ramirez, Alla Polozova, Mara Rossi, Roland Schmidt, Robert Simler, Satish Singh, Thomas M. Spitznagel, Andrew Weiskopf, Klaus Wuchner
    Vol. 104, Issue 6, p1899–1908
  • Developability Assessment During the Selection of Novel Therapeutic Antibodies

    Alexander Jarasch, Hans Koll, Joerg T. Regula, Martin Bader, Apollon Papadimitriou, Hubert Kettenberger
    Vol. 104, Issue 6, p1885–1898
  • Antibody Glycosylation and Its Impact on the Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies and Fc-Fusion Proteins

    Liming Liu
    Vol. 104, Issue 6, p1866–1884
  • Application of Image-Based Particle Size and Shape Characterization Systems in the Development of Small Molecule Pharmaceuticals

    John F. Gamble, Mike Tobyn, Rhye Hamey
    Vol. 104, Issue 5, p1563–1574
  • A Framework for Meta-Analysis of Veterinary Drug Pharmacokinetic Data Using Mixed Effect Modeling

    Mengjie Li, Ronette Gehring, Zhoumeng Lin, Jim Riviere
    Vol. 104, Issue 4, p1230–1239
  • Physicochemical Characterization of Cyclodextrin–Drug Interactions in the Solid State and the Effect of Water on These Interactions

    Noriko Ogawa, Chisato Takahashi, Hiromitsu Yamamoto
    Vol. 104, Issue 3, p942–954
  • The Current Status and Prospects of Antibody Engineering for Therapeutic Use: Focus on Glycoengineering Technology

    Rinpei Niwa, Mitsuo Satoh
    Vol. 104, Issue 3, p930–941
  • Drug–Drug Interactions Related to Altered Absorption and Plasma Protein Binding: Theoretical and Regulatory Considerations, and an Industry Perspective

    Jerome Hochman, Cuyue Tang, Thomayant Prueksaritanont
    Vol. 104, Issue 3, p916–929
  • Excipient Variability and Its Impact on Dosage Form Functionality

    Vivek S. Dave, Suprit D. Saoji, Nishikant A. Raut, Rahul V. Haware
    Vol. 104, Issue 3, p906–915
  • Nanoengineered Drug Delivery Systems for Enhancing Antibiotic Therapy

    Rahul S. Kalhapure, Nadia Suleman, Chunderika Mocktar, Nasreen Seedat, Thirumala Govender
    Vol. 104, Issue 3, p872–905
  • Advancing Drug Discovery: A Pharmaceutics Perspective

    Elizabeth Kwong
    Vol. 104, Issue 3, p865–871
  • Multivalent Nanomaterials: Learning from Vaccines and Progressing to Antigen-Specific Immunotherapies

    Brittany L. Hartwell, Lorena Antunez, Bradley P. Sullivan, Sharadvi Thati, Joshua O. Sestak, Cory Berkland
    Vol. 104, Issue 2, p346–361
  • Hydrogen-Deuterium Exchange Mass Spectrometry as an Emerging Analytical Tool for Stabilization and Formulation Development of Therapeutic Monoclonal Antibodies

    Ranajoy Majumdar, C.Russell Middaugh, David D. Weis, David B. Volkin
    Vol. 104, Issue 2, p327–345
  • Formulation and Stability of Cytokine Therapeutics

    Tiina Lipiäinen, Marikki Peltoniemi, Sanjay Sarkhel, Teijo Yrjönen, Heikki Vuorela, Arto Urtti, Anne Juppo
    Vol. 104, Issue 2, p307–326
  • Anatomical, Physiological, and Experimental Factors Affecting the Bioavailability of sc-Administered Large Biotherapeutics

    Anas M. Fathallah, Sathy V. Balu-Iyer
    Vol. 104, Issue 2, p301–306
  • Two Decades of Publishing Excellence in Pharmaceutical Biotechnology

    David B. Volkin, Susan Hershenson, Rodney J.Y. Ho, Susumu Uchiyama, Gerhard Winter, John F. Carpenter
    Vol. 104, Issue 2, p290–300
  • PAMAM Dendrimers: Destined for Success or Doomed to Fail? Plain and Modified PAMAM Dendrimers in the Context of Biomedical Applications

    Magdalena Labieniec-Watala, Cezary Watala
    Vol. 104, Issue 1, p2–14
  • Enzyme-Transporter-Mediated Drug Interactions with Small Molecule Tyrosine Kinase Inhibitors

    Jie Shao, John S. Markowitz, Di Bei, Guohua An
    Vol. 103, Issue 12, p3810–3833
  • Ethylphenidate as a Selective Dopaminergic Agonist and Methylphenidate–Ethanol Transesterification Biomarker

    Kennerly S. Patrick, Timothy R. Corbin, Cristina E. Murphy
    Vol. 103, Issue 12, p3834–3842
  • Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fluconazole

    Naseem Charoo, Rodrigo Cristofoletti, Alexandra Graham, Paul Lartey, Bertil Abrahamsson, D.W. Groot, Sabine Kopp, Peter Langguth, James Polli, Vinod P. Shah, Jennifer Dressman
    Vol. 103, Issue 12, p3843–3858
  • Historical Data Analyses and Scientific Knowledge Suggest Complete Removal of the Abnormal Toxicity Test as a Quality Control Test

    Joerg H.O. Garbe, Susanne Ausborn, Claire Beggs, Martin Bopst, Angelika Joos, Alexandra A. Kitashova, Olga Kovbasenco, Claus-Dieter Schiller, Martina Schwinger, Natalia Semenova, Lilia Smirnova, Fraser Stodart, Thomas Visalli, Lisette Vromans
    Vol. 103, Issue 11, p3349–3355
    Open Access
  • Improving Monoclonal Antibody Selection and Engineering using Measurements of Colloidal Protein Interactions

    Steven B. Geng, Jason K. Cheung, Chakravarthy Narasimhan, Mohammed Shameem, Peter M. Tessier
    Vol. 103, Issue 11, p3356–3363
  • Dynamic Vapor Sorption as a Tool for Characterization and Quantification of Amorphous Content in Predominantly Crystalline Materials

    Sneha Sheokand, Sameer R. Modi, Arvind K. Bansal
    Vol. 103, Issue 11, p3364–3376
  • The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

    Arzu Selen, Paul A. Dickinson, Anette Müllertz, John R. Crison, Hitesh B. Mistry, Maria T. Cruañes, Marilyn N. Martinez, Hans Lennernäs, Tim L. Wigal, David C. Swinney, James E. Polli, Abu T.M. Serajuddin, Jack A. Cook, Jennifer B. Dressman
    Vol. 103, Issue 11, p3377–3397
  • Composition and Physicochemical Properties of Fasted‐State Human Duodenal and Jejunal Fluid: A Critical Evaluation of the Available Data

    Alexander Fuchs, Jennifer B. Dressman
    Vol. 103, Issue 11, p3398–3411
  • A Commentary on Scale‐Up of Pan Coating Process Using Microenvironmental Control

    Preetanshu Pandey, Dilbir S. Bindra
    Vol. 103, Issue 11, p3412–3415
  • Impact of Study Design on the Evaluation of Inhaled and Intranasal Corticosteroids' Effect on Hypothalamic–Pituitary–Adrenal Axis Function

    Ying Fan, Lian Ma, Jennifer Pippins, Susan Limb, Yun Xu, Chandrahas G. Sahajwalla
    Vol. 103, Issue 10, p2963–2979
  • A Brief Literature and Patent Review of Nanosuspensions to a Final Drug Product

    William Wei Lim Chin, Johannes Parmentier, Michael Widzinski, En Hui Tan, Rajeev Gokhale
    Vol. 103, Issue 10, p2980–2999
  • George Zografi and the Science of Solids and Surfaces

    Lynne S. Taylor, Bruno C. Hancock
    Vol. 103, Issue 9, p2592–2594
  • Critical Considerations for the Qualitative and Quantitative Determination of Process‐Induced Disorder in Crystalline Solids

    Ann Newman, George Zografi
    Vol. 103, Issue 9, p2595–2604
  • Critical Considerations for the Qualitative and Quantitative Determination of Process‐Induced Disorder in Crystalline Solids

    Ann Newman, George Zografi
    Vol. 103, Issue 9, p2595–2604
  • Crystallization from the Amorphous State: Nucleation–Growth Decoupling, Polymorphism Interplay, and the Role of Interfaces

    Marc Descamps, Emeline Dudognon
    Vol. 103, Issue 9, p2615–2628
  • Carnelley's Rule and the Prediction of Melting Point

    Samuel H. Yalkowsky
    Vol. 103, Issue 9, p2629–2634
  • Structural and Dynamic Properties of Amorphous Solid Dispersions: The Role of Solid-State Nuclear Magnetic Resonance Spectroscopy and Relaxometry

    Amrit Paudel, Marco Geppi, Guy Van den Mooter
    Vol. 103, Issue 9, p2635–2662
  • Water Clusters in Amorphous Pharmaceuticals

    Jean‐Rene Authelin, Alan P. MacKenzie, Don H. Rasmussen, Evgenyi Y. Shalaev
    Vol. 103, Issue 9, p2663–2672
  • Next Generation Drying Technologies for Pharmaceutical Applications

    Robert H. Walters, Bakul Bhatnagar, Serguei Tchessalov, Ken-Ichi Izutsu, Kouhei Tsumoto, Satoshi Ohtake
    Vol. 103, Issue 9, p2673–2695
  • A Comprehensive Review of Advanced Biopolymeric Wound Healing Systems

    Naeema Mayet, Yahya E. Choonara, Pradeep Kumar, Lomas K. Tomar, Charu Tyagi, Lisa C. Du Toit, Viness Pillay
    Vol. 103, Issue 8, p2211–2230
  • Silver Nanoparticles: Therapeutical Uses, Toxicity, and Safety Issues

    Carolina Alves Dos Santos, Marcelo Martins Seckler, Avinash P. Ingle, Indarchand Gupta, Stefania Galdiero, Massimiliano Galdiero, Aniket Gade, Mahendra Rai
    Vol. 103, Issue 7, p1931–1944
  • Significance of Metabolites in Bioequivalence: Losartan Potassium as a Case Study

    Naseem Ahmad Charoo, Rodrigo Cristofoletti, Aamer Roshanali Khatri, Areeg Anwer Ali
    Vol. 103, Issue 6, p1584–1591
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Codeine Phosphate

    Arik Dahan, Omri Wolk, Moran Zur, Gordon L. Amidon, Bertil Abrahamsson, Rodrigo Cristofoletti, D.W. Groot, Sabine Kopp, Peter Langguth, James E. Polli, Vinod P. Shah, Jennifer B. Dressman
    Vol. 103, Issue 6, p1592–1600
  • Impact of Residual Impurities and Contaminants on Protein Stability

    Wei Wang, Arun Alphonse Ignatius, Santosh V. Thakkar
    Vol. 103, Issue 5, p1315–1330
  • United States Food and Drug Administration and Department of Defense Shelf-Life Extension Program of Pharmaceutical Products: Progress and Promise

    Saeed R. Khan, Ravikanth Kona, Patrick J. Faustino, Abhay Gupta, Jeb S. Taylor, Donna A. Porter, Mansoor Khan
    Vol. 103, Issue 5, p1331–1336
  • Nanotherapeutics—Product Development Along the “Nanomaterial” Discussion

    Matthias G. Wacker
    Vol. 103, Issue 3, p777–784
  • Patient-Controlled Analgesia: Therapeutic Interventions Using Transdermal Electro-Activated and Electro-Modulated Drug Delivery

    Sunaina Indermun, Yahya E. Choonara, Pradeep Kumar, Lisa C. Du Toit, Girish Modi, Regina Luttge, Viness Pillay
    Vol. 103, Issue 2, p353–366
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam

    Igor E. Shohin, Julia I. Kulinich, Galina V. Ramenskaya, Bertil Abrahamsson, Sabine Kopp, Peter Langguth, James E. Polli, Vinod P. Shah, D.W. Groot, Dirk M. Barends, Jennifer B. Dressman
    Vol. 103, Issue 2, p367–377
  • Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate

    Naseem A. Charoo, Areeg A.A. Shamsher, Lai Y. Lian, Bertil Abrahamsson, Rodrigo Cristofoletti, D.W. Groot, Sabine Kopp, Peter Langguth, James Polli, Vinod P. Shah, Jennifer Dressman
    Vol. 103, Issue 2, p378–391
  • Analysis of Sartans: A Review

    Izabela Muszalska, Agnieszka Sobczak, Agnieszka Dołhań, Anna Jelińska
    Vol. 103, Issue 1, p2–28
  • Emerging Research and Clinical Development Trends of Liposome and Lipid Nanoparticle Drug Delivery Systems

    John C. Kraft, Jennifer P. Freeling, Ziyao. Wang, Rodney J.Y. Ho
    Vol. 103, Issue 1, p29–52
  • Pharmacokinetics of Peptide–Fc Fusion Proteins

    W.U. Benjamin, Yu-Nien Sun
    Vol. 103, Issue 1, p53–64
  • The Impact of the EMA Change in Definition of “Dose” on the BCS Dose–Solubility Ratio: A Review of the Biowaiver Monographs

    Ahmad Sediq, Marlies Kubbinga, Peter Langguth, Jennifer Dressman
    Vol. 103, Issue 1, p65–70
  • Enzyme-Transporter-Mediated Drug Interactions with Small Molecule Tyrosine Kinase Inhibitors

    Jie Shao, John S. Markowitz, Di Bei, Guohua An
    Vol. 103, Issue 12, p3810–3833
  • Ethylphenidate as a Selective Dopaminergic Agonist and Methylphenidate–Ethanol Transesterification Biomarker

    Kennerly S. Patrick, Timothy R. Corbin, Cristina E. Murphy
    Vol. 103, Issue 12, p3834–3842
  • Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fluconazole

    Naseem Charoo, Rodrigo Cristofoletti, Alexandra Graham, Paul Lartey, Bertil Abrahamsson, D.W. Groot, Sabine Kopp, Peter Langguth, James Polli, Vinod P. Shah, Jennifer Dressman
    Vol. 103, Issue 12, p3843–3858
  • Historical Data Analyses and Scientific Knowledge Suggest Complete Removal of the Abnormal Toxicity Test as a Quality Control Test

    Joerg H.O. Garbe, Susanne Ausborn, Claire Beggs, Martin Bopst, Angelika Joos, Alexandra A. Kitashova, Olga Kovbasenco, Claus-Dieter Schiller, Martina Schwinger, Natalia Semenova, Lilia Smirnova, Fraser Stodart, Thomas Visalli, Lisette Vromans
    Vol. 103, Issue 11, p3349–3355
    Open Access
  • Improving Monoclonal Antibody Selection and Engineering using Measurements of Colloidal Protein Interactions

    Steven B. Geng, Jason K. Cheung, Chakravarthy Narasimhan, Mohammed Shameem, Peter M. Tessier
    Vol. 103, Issue 11, p3356–3363
  • Dynamic Vapor Sorption as a Tool for Characterization and Quantification of Amorphous Content in Predominantly Crystalline Materials

    Sneha Sheokand, Sameer R. Modi, Arvind K. Bansal
    Vol. 103, Issue 11, p3364–3376
  • The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

    Arzu Selen, Paul A. Dickinson, Anette Müllertz, John R. Crison, Hitesh B. Mistry, Maria T. Cruañes, Marilyn N. Martinez, Hans Lennernäs, Tim L. Wigal, David C. Swinney, James E. Polli, Abu T.M. Serajuddin, Jack A. Cook, Jennifer B. Dressman
    Vol. 103, Issue 11, p3377–3397
  • Composition and Physicochemical Properties of Fasted‐State Human Duodenal and Jejunal Fluid: A Critical Evaluation of the Available Data

    Alexander Fuchs, Jennifer B. Dressman
    Vol. 103, Issue 11, p3398–3411
  • A Commentary on Scale‐Up of Pan Coating Process Using Microenvironmental Control

    Preetanshu Pandey, Dilbir S. Bindra
    Vol. 103, Issue 11, p3412–3415
  • Impact of Study Design on the Evaluation of Inhaled and Intranasal Corticosteroids' Effect on Hypothalamic–Pituitary–Adrenal Axis Function

    Ying Fan, Lian Ma, Jennifer Pippins, Susan Limb, Yun Xu, Chandrahas G. Sahajwalla
    Vol. 103, Issue 10, p2963–2979
  • A Brief Literature and Patent Review of Nanosuspensions to a Final Drug Product

    William Wei Lim Chin, Johannes Parmentier, Michael Widzinski, En Hui Tan, Rajeev Gokhale
    Vol. 103, Issue 10, p2980–2999
  • George Zografi and the Science of Solids and Surfaces

    Lynne S. Taylor, Bruno C. Hancock
    Vol. 103, Issue 9, p2592–2594
  • Critical Considerations for the Qualitative and Quantitative Determination of Process‐Induced Disorder in Crystalline Solids

    Ann Newman, George Zografi
    Vol. 103, Issue 9, p2595–2604
  • Critical Considerations for the Qualitative and Quantitative Determination of Process‐Induced Disorder in Crystalline Solids

    Ann Newman, George Zografi
    Vol. 103, Issue 9, p2595–2604
  • Crystallization from the Amorphous State: Nucleation–Growth Decoupling, Polymorphism Interplay, and the Role of Interfaces

    Marc Descamps, Emeline Dudognon
    Vol. 103, Issue 9, p2615–2628
  • Carnelley's Rule and the Prediction of Melting Point

    Samuel H. Yalkowsky
    Vol. 103, Issue 9, p2629–2634
  • Structural and Dynamic Properties of Amorphous Solid Dispersions: The Role of Solid-State Nuclear Magnetic Resonance Spectroscopy and Relaxometry

    Amrit Paudel, Marco Geppi, Guy Van den Mooter
    Vol. 103, Issue 9, p2635–2662
  • Water Clusters in Amorphous Pharmaceuticals

    Jean‐Rene Authelin, Alan P. MacKenzie, Don H. Rasmussen, Evgenyi Y. Shalaev
    Vol. 103, Issue 9, p2663–2672
  • Next Generation Drying Technologies for Pharmaceutical Applications

    Robert H. Walters, Bakul Bhatnagar, Serguei Tchessalov, Ken-Ichi Izutsu, Kouhei Tsumoto, Satoshi Ohtake
    Vol. 103, Issue 9, p2673–2695
  • A Comprehensive Review of Advanced Biopolymeric Wound Healing Systems

    Naeema Mayet, Yahya E. Choonara, Pradeep Kumar, Lomas K. Tomar, Charu Tyagi, Lisa C. Du Toit, Viness Pillay
    Vol. 103, Issue 8, p2211–2230
  • Silver Nanoparticles: Therapeutical Uses, Toxicity, and Safety Issues

    Carolina Alves Dos Santos, Marcelo Martins Seckler, Avinash P. Ingle, Indarchand Gupta, Stefania Galdiero, Massimiliano Galdiero, Aniket Gade, Mahendra Rai
    Vol. 103, Issue 7, p1931–1944
  • Significance of Metabolites in Bioequivalence: Losartan Potassium as a Case Study

    Naseem Ahmad Charoo, Rodrigo Cristofoletti, Aamer Roshanali Khatri, Areeg Anwer Ali
    Vol. 103, Issue 6, p1584–1591
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Codeine Phosphate

    Arik Dahan, Omri Wolk, Moran Zur, Gordon L. Amidon, Bertil Abrahamsson, Rodrigo Cristofoletti, D.W. Groot, Sabine Kopp, Peter Langguth, James E. Polli, Vinod P. Shah, Jennifer B. Dressman
    Vol. 103, Issue 6, p1592–1600
  • Impact of Residual Impurities and Contaminants on Protein Stability

    Wei Wang, Arun Alphonse Ignatius, Santosh V. Thakkar
    Vol. 103, Issue 5, p1315–1330
  • United States Food and Drug Administration and Department of Defense Shelf-Life Extension Program of Pharmaceutical Products: Progress and Promise

    Saeed R. Khan, Ravikanth Kona, Patrick J. Faustino, Abhay Gupta, Jeb S. Taylor, Donna A. Porter, Mansoor Khan
    Vol. 103, Issue 5, p1331–1336
  • Nanotherapeutics—Product Development Along the “Nanomaterial” Discussion

    Matthias G. Wacker
    Vol. 103, Issue 3, p777–784
  • Patient-Controlled Analgesia: Therapeutic Interventions Using Transdermal Electro-Activated and Electro-Modulated Drug Delivery

    Sunaina Indermun, Yahya E. Choonara, Pradeep Kumar, Lisa C. Du Toit, Girish Modi, Regina Luttge, Viness Pillay
    Vol. 103, Issue 2, p353–366
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam

    Igor E. Shohin, Julia I. Kulinich, Galina V. Ramenskaya, Bertil Abrahamsson, Sabine Kopp, Peter Langguth, James E. Polli, Vinod P. Shah, D.W. Groot, Dirk M. Barends, Jennifer B. Dressman
    Vol. 103, Issue 2, p367–377
  • Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate

    Naseem A. Charoo, Areeg A.A. Shamsher, Lai Y. Lian, Bertil Abrahamsson, Rodrigo Cristofoletti, D.W. Groot, Sabine Kopp, Peter Langguth, James Polli, Vinod P. Shah, Jennifer Dressman
    Vol. 103, Issue 2, p378–391
  • Analysis of Sartans: A Review

    Izabela Muszalska, Agnieszka Sobczak, Agnieszka Dołhań, Anna Jelińska
    Vol. 103, Issue 1, p2–28
  • Emerging Research and Clinical Development Trends of Liposome and Lipid Nanoparticle Drug Delivery Systems

    John C. Kraft, Jennifer P. Freeling, Ziyao. Wang, Rodney J.Y. Ho
    Vol. 103, Issue 1, p29–52
  • Pharmacokinetics of Peptide–Fc Fusion Proteins

    W.U. Benjamin, Yu-Nien Sun
    Vol. 103, Issue 1, p53–64
  • The Impact of the EMA Change in Definition of “Dose” on the BCS Dose–Solubility Ratio: A Review of the Biowaiver Monographs

    Ahmad Sediq, Marlies Kubbinga, Peter Langguth, Jennifer Dressman
    Vol. 103, Issue 1, p65–70
  • The Effect of Parenterally Administered Cyclodextrins on the Pharmacokinetics of Coadministered Drugs

    Sergey V. Kurkov, Donna E. Madden, Daniel Carr, Thorsteinn Loftsson
    Vol. 101, Issue 12, p4402–4408
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Amodiaquine Hydrochloride

    Anita Nair, Bertil Abrahamsson, Dirk M. Barends, D.W. Groot, Sabine Kopp, James E. Polli, Vinod P. Shah, Jennifer B. Dressman
    Vol. 101, Issue 12, p4390–4401
  • Regulatory Review of Acetaminophen Clinical Pharmacology in Young Pediatric Patients

    Ping Ji, Yaning Wang, Zhihong Li, Suresh Doddapaneni, Sharon Hertz, Scott Furness, Chandrahas G. Sahajwalla
    Vol. 101, Issue 12, p4383–4389
  • Application of pharmacokinetics–pharmacodynamics/clinical response modeling and simulation for biologics drug development

    Liang Zhao, Elizabeth Y. Shang, Chandrahas G. Sahajwalla
    Vol. 101, Issue 12, p4367–4382
  • Impact of the Pharmaceutical Sciences on Health Care: A Reflection over the Past 50 Years

    Malcolm Rowland, Christian R. Noe, Dennis A. Smith, G.T. Tucker, Daan J.A. Crommelin, Carl C. Peck, Mario L. Rocci Jr., Luc Besançon, Vinod P. Shah
    Vol. 101, Issue 11, p4075–4099
  • Formulation Approaches to Short Interfering RNA and MicroRNA: Challenges and Implications

    Diana Guzman-Villanueva, Ibrahim M. El-Sherbiny, Dea Herrera-Ruiz, Alexander V. Vlassov, Hugh D.C. Smyth
    Vol. 101, Issue 11, p4046–4066
  • Active Compounds Release from Semisolid Dosage Forms

    Anna Olejnik, Joanna Goscianska, Izabela Nowak
    Vol. 101, Issue 11, p4032–4045
  • Heat Transfer Characteristics of Current Primary Packaging Systems for Pharmaceutical Freeze-Drying

    Susanne Hibler, Henning Gieseler
    Vol. 101, Issue 11, p4025–4031
  • Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi‐step design space

    Alex Eon-Duval, Pascal Valax, Thomas Solacroup, Hervé Broly, Ralf Gleixner, Claire Le Strat, James Sutter
    Vol. 101, Issue 10, p3604–3618
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Ketoprofen

    Igor E. Shohin, Julia I. Kulinich, Galina V. Ramenskaya, Bertil Abrahamsson, Sabine Kopp, Peter Langguth, James E. Polli, Vinod P. Shah, D.W. Groot, Dirk M. Barends, Jennifer B. Dressman
    Vol. 101, Issue 10, p3593–3603
  • Models for evaluation of relative immunogenic potential of protein particles in biopharmaceutical protein formulations

    Richard Johnson, Wim Jiskoot
    Vol. 101, Issue 10, p3586–3592
  • The future of protein particle characterization and understanding its potential to diminish the immunogenicity of biopharmaceuticals: A shared perspective

    Jared S. Bee, Theresa J. Goletz, Jack A. Ragheb
    Vol. 101, Issue 10, p3580–3585
  • Protein particles: What we know and what we do not know

    Dean C. Ripple, Mariana N. Dimitrova
    Vol. 101, Issue 10, p3568–3579
  • Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins

    Amy S. Rosenberg, Daniela Verthelyi, Barry W. Cherney
    Vol. 101, Issue 10, p3560–3567
  • Workshop on predictive science of the immunogenicity aspects of particles in biopharmaceutical products

    Ewa Marszal, Elizabeth Fowler
    Vol. 101, Issue 10, p3555–3559
  • Perspective on Improving Passive Human Intestinal Absorption

    Samuel H. Yalkowsky
    Vol. 101, Issue 9, p3047–3050
  • Pharmaceutical Aspects of the Recombinant Human Serum Albumin Dimer: Structural Characteristics, Biological Properties, and Medical Applications

    Kazuaki Taguchi, Victor Tuan Giam Chuang, Toru Maruyama, Masaki Otagiri
    Vol. 101, Issue 9, p3033–3046
  • Cyclodextrins as Functional Excipients: Methods to Enhance Complexation Efficiency

    Thorsteinn Loftsson, Marcus E. Brewster
    Vol. 101, Issue 9, p3019–3032
  • Solution-Mediated Phase Transformation: Significance During Dissolution and Implications for Bioavailability

    Kristyn Greco, Robin Bogner
    Vol. 101, Issue 9, p2996–3018
  • Professor Valentino J. Stella: Scientist, Mentor, Entrepreneur, Family Man, and Giant in Pharmaceutical Chemistry

    Reza Oliyai, Marcus E. Brewster, Tetsuya Ozeki, Roger A. Rajewski, William Charman
    Vol. 101, Issue 9, p2989–2995
  • Molecular Nanomedicine Towards Cancer: 111In-Labeled Nanoparticles

    Dimitrios Psimadas, Panagiotis Georgoulias, Varvara Valotassiou, George Loudos
    Vol. 101, Issue 7, p2271–2280
  • Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Acetylsalicylic Acid

    Jennifer B. Dressman, Anita Nair, Bertil Abrahamsson, Dirk M. Barends, D.W. Groot, Sabine Kopp, Peter Langguth, James E. Polli, Vinod P. Shah, Markus Zimmer
    Vol. 101, Issue 8, p2653–2667
  • Evaluation of Hepatic Clearance Prediction Using In Vitro Data: Emphasis on Fraction Unbound in Plasma and Drug Ionisation Using a Database of 107 Drugs

    David Hallifax, J. Brian Houston
    Vol. 101, Issue 8, p2645–2652
  • The Potential Clinical Relevance of Visible Particles in Parenteral Drugs

    Lucette Doessegger, Hanns-Christian Mahler, Piotr Szczesny, Helmut Rockstroh, Georg Kallmeyer, Anja Langenkamp, Joerg Herrmann, Joseph Famulare
    Vol. 101, Issue 8, p2635–2644
  • Dosing Regimen Determination for Juvenile Idiopathic Arthritis: A Review of Studies During Drug Development

    Ping Ji, Badrul A. Chowdhury, Sarah Yim, Chandrahas G. Sahajwalla
    Vol. 101, Issue 8, p2621–2634
  • Qualitative and Quantitative Intravaginal Targeting: Key to Anti-HIV-1 Microbicide Delivery from Test Tube to In Vivo Success

    Viness Pillay, Felix Mashingaidze, Yahya E. Choonara, Lisa C. Du Toit, Eckhart Buchmann, Vinesh Maharaj, Valence M.K. Ndesendo, Pradeep Kumar
    Vol. 101, Issue 6, p1950–1968
  • Type 2 Diabetes in Pediatrics and Adults: Thoughts from a Clinical Pharmacology Perspective

    Jayabharathi Vaidyanathan, Sally Choe, Chandrahas G. Sahajwalla
    Vol. 101, Issue 5, p1659–1671
  • Interleukin-1 Receptor Antagonist: A New Therapy for Type 2 Diabetes Mellitus

    Muhammad Sajid Hamid Akash, Qi Shen, Kanwal Rehman, Shuqing Chen
    Vol. 101, Issue 5, p1647–1658
  • Assessing the performance of amorphous solid dispersions

    Ann Newman, Gregory Knipp, George Zografi
    Vol. 101, Issue 4, p1355–1377
  • Protein Instability and Immunogenicity: Roadblocks to Clinical Application of Injectable Protein Delivery Systems for Sustained Release

    Wim Jiskoot, Theodore W. Randolph, David B. Volkin, C. Russell Middaugh, Christian Schöneich, Gerhard Winter, Wolfgang Friess, Daan J.A. Crommelin, John F. Carpenter
    Vol. 101, Issue 3, p946–954
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Primaquine Phosphate

    Anita Nair, Bertil Abrahamsson, Dirk M. Barends, D.W. Groot, Sabine Kopp, James E. Polli, Vinod P. Shah, Jennifer B. Dressman
    Vol. 101, Issue 3, p936–945
  • Forced Degradation of Therapeutic Proteins

    Andrea Hawe, Michael Wiggenhorn, Marco van de Weert, Joerg H.O. Garbe, Hanns-christian Mahler, Wim Jiskoot
    Vol. 101, Issue 3, p895–913
  • First Century of Chagas' Disease: An Overview on Novel Approaches to Nifurtimox and Benznidazole Delivery Systems

    Claudio J. Salomon
    Vol. 101, Issue 3, p888–894
  • Classification of Protein Aggregates

    Linda O. Narhi, Jeremy Schmit, Karoline Bechtold-Peters, Deepak Sharma
    Vol. 101, Issue 2, p493–498
  • Robustness Index Score: A New Stability Parameter for Designing Robustness into Biologic Formulations

    Anthony J. Lonardo, Arvind Srivastava, Swita Singh, Joel Goldstein
    Vol. 101, Issue 2, p485–492
  • Polymorphism and Solvatomorphism 2010

    Harry G. Brittain
    Vol. 101, Issue 2, p464–484
  • Application of Mesoporous Silicon Dioxide and Silicate in Oral Amorphous Drug Delivery Systems

    Ken K. Qian, Robin H. Bogner
    Vol. 101, Issue 2, p444–463
  • Aluminum Adjuvant Dose Guidelines in Vaccine Formulation for Preclinical Evaluations

    Simone Vecchi, Simone Bufali, David A.G. Skibinski, Derek T. O'hagan, Manmohan Singh
    Vol. 101, Issue 1, p17–20
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Stavudine

    Arthur L.L. Silva, Rodrigo Cristofoletti, Silvia Storpirtis, Varley D. Sousa, Hans E. Junginger, Vinod P. Shah, Salomon Stavchansky, Jennifer B. Dressman, Dirk M. Barends
    Vol. 101, Issue 1, p10–16
  • Supersaturating Drug Delivery Systems: Fast is Not Necessarily Good Enough

    Patrick Augustijns, Marcus E. Brewster
    Vol. 101, Issue 1, p7–9
  • A survey of Top 200 Drugs—Inconsistent Practice of Drug Strength Expression for Drugs Containing Salt Forms

    Daniel L. Prohotsky, Fang Zhao
    Vol. 101, Issue 1, p1–6
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