Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA

AAPS Journal

Volumn 14, Issue 4, 2012, Pages 664-666

  Nair, Anil K ^a   Anand, Om ^a   Chun, Nam ^a   Conner, Dale P ^a   Mehta, Mehul U ^a   Nhu, Duong T ^a   Polli, James E ^b   Yu, Lawrence X ^a   Davit, Barbara M ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

Author keywords

ANDA; BCS biowaiver; Bioequivalence; Biopharmaceutics Classification System; Generic drug product

Indexed keywords

ANTIALLERGIC AGENT; ANTIDIABETIC AGENT; GENERIC DRUG;

BIOEQUIVALENCE; BIOPHARMACEUTICS CLASSIFICATION SYSTEM; DRUG APPROVAL; DRUG CLASSIFICATION; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; INTESTINE MUCOSA PERMEABILITY; REVIEW; STATISTICS; WORLD HEALTH ORGANIZATION;

DRUG APPROVAL; DRUG DESIGN; DRUGS, ESSENTIAL; DRUGS, GENERIC; HUMANS; INTESTINAL ABSORPTION; SOLUBILITY; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WORLD HEALTH ORGANIZATION;

EID: 84869102159     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9384-z     Document Type: Review

References (7)

1. Amidon GL, Lennernas H, Shah VP, Crison Jr. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12:413-20.
2. CDER/FDA.Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate release dosage forms based on a biopharmaceutical classification system, Center for Drug Evaluation and Research; 2000 At: www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf. Accessed 18 June 2012.
3. Dahan A, Miller JM, Amidon GL. Prediction of solubility and permeability class membership: provisional BCS classification of the world's top oral drugs. AAPS J. 2009;11:740-6.
4. WHO. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Annex 8 of WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva: WHO Technical Report Series No. 937, 2006; 40th edition: pp 391-461. At: http://www.who.int/medicines/publications/essentialmedicines/en/index.html. Accessed 18 June 2012.
5. CDER/FDA. Guidance for industry: immediate release solid oral dosage forms: scale-up and postapproval changes: chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation, Center for Drug Evaluation and Research; 1995. At: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070636.pdf. Accessed 18 June 2012.
6. Cook JA, Davit BM, Polli JE. Impact of biopharmaceutics classification system-based biowaivers. Mol Pharm. 2010;7:1539-44.
7. Lindenberg M, Kopp S, Dressman JB. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. Eur J Pharm Sci. 2004;58:265-78.