The BCS, BDDCS, and Regulatory Guidances

Author:

Chen Mei-Ling,Amidon Gordon L.,Benet Leslie Z.,Lennernas Hans,Yu Lawrence X.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Reference19 articles.

1. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutics drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12:413–20.

2. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. 2000 August. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf .

3. Committee for Medicinal Products for Human Use, European Medicines Agency. Guideline on the Investigation of Bioequivalence. 2010 January 20. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf .

4. Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a Biopharmaceutics Drug Disposition Classification System. Pharm Res. 2005;22:11–23.

5. Benet LZ, Amidon GL, Barends DM, Lennernäs H, Polli JE, Shah VP, et al. The use of BDDCS in classifying the permeability of marketed drugs. Pharm Res. 2008;52(3):483–8.

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