Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology
Reference79 articles.
1. Yu A, Sun D, Li BV, Lawrence XY. Bioequivalence history. FDA Bioequivalence standards: Springer; 2014. p. 1-27.
2. 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(3):413–20.
3. Wu C-Y, 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(1):11–23.
4. European Medicines Agency (EMA). Guideline on the Investigation of Bioequivalence, Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr., London, 20 January 2010 [Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.
5. Midha KK, McKay G. Bioequivalence; its history, practice, and future. AAPS J. 2009;11(4):664–70.