Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?-Reference-Cited by-同舟云学术

Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?

Published:2015-10-01 Issue:1 Volume:18 Page:15-22
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Diaz Dorys Argelia,Colgan Stephen T.,Langer Connie S.,Bandi Nagesh T.,Likar Michael D.,Van Alstine Leslie

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-015-9830-9.pdf

Reference29 articles.

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3. Xie F, Ji S, Cheng Z. In vitro dissolution similarity factor (f2) and in vivo bioequivalence criteria, how and when do they match? using a BCS class II drug as a simulation example. Eur J Pharm Sci. 2015;66:163–72.

4. FDA Guidance for Industry. SUPAC-IR. 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. 1995.

5. European Medicines Agency. Committee for medicinal products for human use. Guideline on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev.1/Corr**. 2010.

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