Biowaiver Monographs - Free Virtual Issue

We are pleased to now collate all previously published Biowaiver Monographs from Journal of Pharmaceutical Science. These articles are freely available and we hope you enjoy reading them.

  • Evaluation of Differences in Dosage Form Performance of Generics Using BCS-Based Biowaiver Specifications and Biopharmaceutical Modeling–Case Examples Amoxicillin and Doxycycline

    Martin A. Hofsäss, Jennifer Dressman
    Vol. 109, Issue 8, p2437–2453
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate

    Gerlinde F. Plöger, Paul M. Quizon, Bertil Abrahamsson, Rodrigo Cristofoletti, Dirk W. Groot, Alan Parr, Peter Langguth, James E. Polli, Vinod P. Shah, Tomokazu Tajiri, Mehul U. Mehta, Jennifer Dressman
    Vol. 109, Issue 6, p1846–1862
  • Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron

    Gopal Singh Rajawat, Tejashree Belubbi, Mangal S. Nagarsenker, Bertil Abrahamsson, Rodrigo Cristofoletti, Dirk W. Groot, Peter Langguth, Alan Parr, James E. Polli, Mehul Mehta, Vinod P. Shah, Tomokazu Tajiri, Jennifer Dressman
    Vol. 108, Issue 10, p3157–3168
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid

    Martin A. Hofsäss, Jacqueline de Souza, Neila M. Silva-Barcellos, Karime R. Bellavinha, Bertil Abrahamsson, Rodrigo Cristofoletti, D.W. Groot, Alan Parr, Peter Langguth, James E. Polli, Vinod P. Shah, Tomokazu Tajiri, Mehul U. Mehta, Jennifer B. Dressman
    Vol. 106, Issue 12, p3421–3430
  • 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
    Vol. 106, Issue 8, p1933–1943
  • Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate

    Dhanusha Thambavita, Priyadarshani Galappatthy, Uthpali Mannapperuma, Lal Jayakody, Rodrigo Cristofoletti, Bertil Abrahamsson, Dirk W. Groot, Peter Langguth, Mehul Mehta, Alan Parr, James E. Polli, Vinod P. Shah, Jennifer Dressman
    Vol. 106, Issue 10, p2930–2945
  • 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
    Vol. 105, Issue 4, p1362–1369
  • 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
  • On the Biopharmaceutics Classification System Biowaiver of Ibuprofen

    Alfredo García-Arieta, John Gordon, Henrike Potthast
    Vol. 104, Issue 8, p2429–2432
  • 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
  • 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
  • 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
  • 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 Monographs for Immediate-Release Solid Oral Dosage Forms: Zidovudine (Azidothymidine)

    Kelen C.C. Soares, Camila F. Rediguieri, Jacqueline Souza, Cristina Helena R. Serra, Bertil Abrahamsson, D.W. Groot, Sabine Kopp, Peter Langguth, James E. Polli, Vinod P. Shah, Jennifer Dressman
    Vol. 102, Issue 8, p2409–2423
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Efavirenz

    Rodrigo Cristofoletti, Anita Nair, Bertil Abrahamsson, D.W. Groot, Sabine Kopp, Peter Langguth, James E. Polli, Vinod P. Shah, Jennifer B. Dressman
    Vol. 102, Issue 2, p318–329
  • 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
  • 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
  • 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
  • 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
  • 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
  • Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Quinine Sulfate

    Stefanie Strauch, Jennifer B. Dressman, Vinod P. Shah, Sabine Kopp, James E. Polli, Dirk M. Barends
    Vol. 101, Issue 2, p499–508
  • 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
  • COMMENTARY: Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Lamivudine

    S. Strauch, E. Jantratid, J.B. Dressman, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, D.M. Barends
    Vol. 100, Issue 6, p2054–2063
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metronidazole

    Camila F. Rediguieri, Valentina Porta, Diana S. G. Nunes, Taina M. Nunes, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon Stavchansky, Jennifer B. Dressman, Dirk M. Barends
    Vol. 100, Issue 5, p1618–1627
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ciprofloxacin Hydrochloride

    M.E. Olivera, R.H. Manzo, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends
    Vol. 100, Issue 1, p22–33
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Mefloquine Hydrochloride

    S. Strauch, E. Jantratid, J.B. Dressman, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, D.M. Barends
    Vol. 100, Issue 1, p11–21
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Furosemide

    G.E Granero, M.R. Longhi, M.J. Mora, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends
    Vol. 99, Issue 6, p2544–2556
  • Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate

    E. Jantratid, S. Strauch, C. Becker, J.B. Dressman, G.L. Amidon, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, D.M. Barends
    Vol. 99, Issue 4, p1639–1653
  • Biowaiver monographs for immediate release solid oral dosage forms: Rifampicin

    C. Becker, J.B. Dressman, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, D.M. Barends
    Vol. 98, Issue 7, p2252–2267
  • Biowaiver monographs for immediate release solid oral dosage forms: Quinidine sulfate

    S. Grube, P. Langguth, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends
    Vol. 98, Issue 7, p2238–2251
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

    B.Chuasuwan, V. Binjesoh, J.E. Polli, H. Zhang, G.L. Amidon, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends
    Vol. 98, Issue 4, p1206–1219
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Acetazolamide

    G.E. Granero, M.R. Longhi, C. Becker, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends
    Vol. 97, Issue 9, p3691–3699
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage forms: Metoclopramide Hydrochloride

    A.G. Stosik, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends
    Vol. 97, Issue 9, p3700–3708
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Pyrazinamide

    C. Becker, J.B. Dressman, G.L. Amidon, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, D.M. Barends
    Vol. 97, Issue 9, p3709–3720
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ethambutol Dihydrochloride

    C. Becker, J.B. Dressman, G.L. Amidon, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, D.M. Barends
    Vol. 97, Issue 4, p1350–1360
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Prednisone

    M. Vogt, H. Derendorf, J. Krämer, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends
    Vol. 96, Issue 6, p1480–1489
  • Biowaiver Monographs for Immediate Release Solid OralDosage Forms: Prednisolone

    M. Vogt, H. Derendorf, J. Krämer, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends
    Vol. 96, Issue 1, p27–37
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Isoniazid

    C. Becker, J.B. Dressman, G.L. Amidon, H.E. Junginger, S. Kopp, K.K. Midha, V.P. Shah, S. Stavchansky, D.M. Barends
    Vol. 96, Issue 3, p522–531
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Amitriptyline Hydrochloride

    R.H. Manzo, M.E. Olivera, G.L. Amidon, V.P. Shah, J.B. Dressman, D.M. Barends
    Vol. 95, Issue 5, p966–973
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cimetidine

    E. Jantratid, S. Prakongpan, J.B. Dressman, G.L. Amidon, H.E. Junginger, K.K. Midha, D.M. Barends
    Vol. 95, Issue 5, p974–984
  • Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (paracetamol)

    L. Kalantzi, C. Reppas, J.B. Dressman, G.L. Amidon, H.E. Junginger, K.K. Midha, V.P. Shah, S.A. Stavchansky, Dirk M. Barends
    Vol. 95, Issue 1, p4–14
  • Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ibuprofen

    H. Potthast, J.B. Dressman, H.E. Junginger, K.K. Midha, H. Oeser, V.P. Shah, H. Vogelpoel, D.M. Barends
    Vol. 94, Issue 10, p2121–2131
  • Biowaiver monographs for immediate release solid oral dosage forms: Ranitidine hydrochloride

    H. Kortejärvi, M. Yliperttula, J.B. Dressman, H.E. Junginger, K.K. Midha, V.P. Shah, D.M. Barends
    Vol. 94, Issue 8, p1617–1625
  • Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride

    R.K. Verbeeck, H.E. Junginger, K.K. Midha, V.P. Shah, D.M. Barends
    Vol. 94, Issue 7, p1389–1395
  • Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol

    H. Vogelpoel, J. Welink, G.L. Amidon, H.E. Junginger, K.K. Midha, H. Möller, M. Olling, V.P. Shah, D.M. Barends
    Vol. 93, Issue 8, p1945–1956
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