Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA

Author:

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

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference7 articles.

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.

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