Concepedia

Biopharmaceutics Classification System

The Biopharmaceutics Classification System is a scientific and regulatory framework in biopharmaceutics that classifies drug substances into four classes according to their aqueous solubility and intestinal permeability in order to predict their oral absorption characteristics and to inform bioequivalence evaluation and biowaiver decisions.

37

Publications

3.2K

Citations

169

Authors

87

Institutions

Publications per year

2017–2026

4

Variants

BcsBiopharmaceutical Classification System

Parents

Children

Publications

37

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

The Developability Classification System: Application of Biopharmaceutics Concepts to Formulation Development

James Butler, Jennifer Dressman · Journal of Pharmaceutical Sciences · 2010 · 412 citations · Full text

, , +16

The Biopharmaceutics Classification System: Subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC

Yasuhiro Tsume, Deanna M. Mudie, Peter Langguth et al. · European Journal of Pharmaceutical Sciences · 2014 · 341 citations

, , +13

The “High Solubility” Definition of the Current FDA Guidance on Biopharmaceutical Classification System May Be Too Strict for Acidic Drugs

Mehran Yazdanian, Katherine Briggs, Corinne Jankovsky et al. · Pharmaceutical Research · 2004 · 283 citations

, , +16

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

1–5 of 37

Authors

169

  1. JC
    Jack Cook

    Pfizer (United States), United States

    5 publications · 244 citations

    5

    h-index

  2. JE
    James E. Polli

    University of Maryland, Baltimore, United States

    5 publications · 793 citations

    5

    h-index

  3. VP
    Vinod P. Shah

    Center for Drug Evaluation and Research, United States

    4 publications · 862 citations

    4

    h-index

  4. GL
    Gordon L. Amidon

    University of Michigan, United States

    4 publications · 924 citations

    4

    h-index

  5. JD
    Jennifer Dressman

    Goethe University Frankfurt, Germany

    4 publications · 560 citations

    4

    h-index

1–5 of 169

Institutions

87

  1. Center for Drug Evaluation and Research

    Silver Spring, United States

    6 h-index

    27 publications

    6.6K citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    6 h-index

    12 publications

    577 citations

  3. University of Michigan

    Ann Arbor, United States

    5 h-index

    11 publications

    3.1K citations

  4. Pfizer (United States)

    New York, United States

    4 h-index

    6 publications

    365 citations

  5. University of Maryland, Baltimore

    Baltimore, United States

    4 h-index

    7 publications

    1.1K citations

  6. Merck & Co., Inc., Rahway, NJ, USA (United States)

    Rahway, United States

    3 h-index

    3 publications

    190 citations

  7. Uppsala University

    Uppsala, Sweden

    3 h-index

    8 publications

    288 citations

  8. Boehringer Ingelheim (United States)

    Ridgefield, United States

    3 h-index

    5 publications

    940 citations

1–8 of 87

Venues

  1. Journal of Pharmaceutical Sciences

    6 publications · 834 citations

    6

    h-index

  2. Molecular Pharmaceutics

    5 publications · 239 citations

    5

    h-index

  3. European Journal of Pharmaceutical Sciences

    4 publications · 483 citations

    4

    h-index

  4. Dissolution Technologies

    3 publications · 102 citations

    3

    h-index

  5. Asian Journal of Pharmaceutics

    AJP · 2 publications · 67 citations

    2

    h-index

1–5