Concepedia

Bcs-based Biowaivers

BCS-Based Biowaivers is a regulatory science framework that permits the waiver of in vivo bioequivalence studies for certain immediate-release oral solid dosage forms by demonstrating that the drug product meets the criteria of the Biopharmaceutics Classification System, namely high solubility and high permeability, and is formulated with excipients that do not significantly affect absorption.

51

Publications

3.2K

Citations

193

Authors

92

Institutions

Publications per year

2017–2026

11

Variants

Biopharmaceutics Classification System-based Biowaivers

Parents

Publications

51

Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions

Lawrence X. Yu, Gordon L. Amidon, James E. Polli et al. · Pharmaceutical Research · 2002 · 565 citations · Full text

, , +11

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, Jan Welink, Gordon L. Amidon et al. · Journal of Pharmaceutical Sciences · 2004 · 177 citations

, , +17

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Isoniazid**A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs.

Corina Becker, Jennifer Dressman, Gordon L. Amidon et al. · Journal of Pharmaceutical Sciences · 2006 · 155 citations · Full text

, , +11

Biowaiver extension potential to BCS Class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tablet

Chen‐Hsi Chou · European Journal of Pharmaceutical Sciences · 2004 · 140 citations

, , +16

Biopharmaceutics classification system

CN Patel, IS Anand · Systematic Reviews in Pharmacy · 2010 · 118 citations

, , +17

1–5 of 51

Authors

193

  1. GL
    Gordon L. Amidon

    University of Michigan, United States

    8 publications · 1.3K citations

    8

    h-index

  2. VP
    Vinod P. Shah

    Center for Drug Evaluation and Research, United States

    7 publications · 1.1K citations

    7

    h-index

  3. JD
    Jennifer Dressman

    Goethe University Frankfurt, Germany

    6 publications · 352 citations

    6

    h-index

  4. DB
    D.M. Barends

    National Institute for Public Health and the Environment, Netherlands

    5 publications · 494 citations

    5

    h-index

  5. KM
    K.K. Midha

    University of Saskatchewan, Canada

    5 publications · 494 citations

    5

    h-index

1–5 of 193

Institutions

92

  1. University of Michigan

    Ann Arbor, United States

    8 h-index

    10 publications

    1.5K citations

  2. University of Saskatchewan

    Saskatoon, Canada

    5 h-index

    5 publications

    494 citations

  3. Goethe University Frankfurt

    Frankfurt am Main, Germany

    5 h-index

    10 publications

    674 citations

  4. United States Food and Drug Administration

    Silver Spring, United States

    5 h-index

    12 publications

    554 citations

  5. National Institute for Public Health and the Environment

    De Bilt, The Netherlands

    5 h-index

    6 publications

    671 citations

  6. Center for Drug Evaluation and Research

    Silver Spring, United States

    4 h-index

    13 publications

    4.9K citations

  7. University of Maryland, Baltimore

    Baltimore, United States

    4 h-index

    6 publications

    770 citations

  8. Pfizer (United States)

    New York, United States

    4 h-index

    7 publications

    288 citations

1–8 of 92

Venues

  1. Journal of Pharmaceutical Sciences

    11 publications · 703 citations

    11

    h-index

  2. Molecular Pharmaceutics

    8 publications · 429 citations

    8

    h-index

  3. Pharmaceutical Research

    4 publications · 730 citations

    4

    h-index

  4. European Journal of Pharmaceutical Sciences

    4 publications · 279 citations

    4

    h-index

  5. The AAPS Journal

    AAPSJ · 2 publications · 123 citations

    2

    h-index

1–5