Publisher
Springer Science and Business Media LLC
Reference16 articles.
1. Wang Q, Fotaki N, Mao Y. Biorelevant dissolution: methodology and application in drug development. Dissolut Technol. 2009;16(3):6–12.
2. Anand O, Lawrence XY, Conner DP, Davit BM. Dissolution testing for generic drugs: an FDA perspective. AAPS J. 2011;13(3):328–35.
3. Shah VP. Dissolution: a quality control test vs. a bioequivalence test. Dissolut Technol. 2001;8(4):6–7.
4. Duan JZ, Riviere K, Marroum P. In vivo bioequivalence and in vitro similarity factor (f 2) for dissolution profile comparisons of extended release formulations: how and when do they match? Pharm Res. 2011;28(5):1144–56.
5. U.S. Food and Drug Administration/Center for Drug Evaluation and Research. 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. November 1995. http://www.fda.gov/downloads/Drugs/Guidances/UCM070636.pdf (Accessed on 11 June 2015).
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