In Vivo Bioequivalence and In Vitro Similarity Factor (f2) for Dissolution Profile Comparisons of Extended Release Formulations: How and When Do They Match?

Author:

Duan John Z.,Riviere Kareen,Marroum Patrick

Publisher

Springer Science and Business Media LLC

Subject

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

Reference20 articles.

1. FDA. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products—general considerations. Rockville, MD; 2003.

2. FDA. Guidance for industry immediate-release solid oral dosage forms: scale-up and post-approval changes: chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. Rockville; 1995.

3. FDA. Guidance for industry dissolution testing of immediate release solid oral dosage forms. Rockville, MD; 1997.

4. FDA. Guidance for industry SUPAC-MR: modified release solid oral dosage forms. Scale-up and postapproval changes: chemistry, manufacturing, and controls; in vitro dissolution testing and in vivo bioeaquivalence documentation. Rockville, MD; 1997.

5. FDA. Guidance for industry extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. Rockville, MD; 1997.

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