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The AAPS Journal

, 13:328 | Cite as

Dissolution Testing for Generic Drugs: An FDA Perspective

  • Om Anand
  • Lawrence X. Yu
  • Dale P. Conner
  • Barbara M. Davit
Regulatory Note Theme: Pharmacokinetics, Biopharmaceutics and Bioequivalence: History and Perspectives

Abstract

In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms. The dissolution method should be developed using an appropriate validated method depending on the dosage form. There are several ways in which dissolution testing plays a pivotal role in regulatory decision-making. It may be used to waive in vivo bioequivalence (BE) study requirements, as BE documentation for Scale Up and Post Approval Changes (SUPAC), and to predict the potential for a modified-release (MR) drug product to dose-dump if co-administered with alcoholic beverages. Thus, in vitro dissolution testing plays a major role in FDA’s efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products.

KEY WORDS

bioequivalence biopharmaceutics generic drugs in vitro dissolution quality by design 

Notes

ACKNOWLEDGMENTS

The authors would like to thank Dr. Xiaojian Jiang for her valuable suggestions.

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Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  • Om Anand
    • 1
  • Lawrence X. Yu
    • 1
  • Dale P. Conner
    • 1
  • Barbara M. Davit
    • 1
  1. 1.U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchOffice of Generic DrugsRockvilleUSA

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