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The Role of in Vitro-in Vivo Correlations (IVIVC) to Regulatory Agencies

  • Henry J. Malinowski
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 423)

Abstract

Dissolution testing remains a potentially powerful and nearly always useful method for obtaining data related to quality and, potentially, clinical performance of dosage forms, especially solid oral dosage forms. But, not surprisingly, dissolution is not always a surrogate for bioequivalence, which necessitates human testing for determination of bioequivalence in many instances. The key to confidence in dissolution testing is the strength of the relationship between dissolution and bioequivalence, in other words, the ability of dissolution testing to predict in vivo performance. Therefore, the availability of an IVIVC, as well as the type of dissolution testing conducted, are important considerations.

Keywords

Extended Release Dissolution Profile Dissolution Testing Immediate Release Draft Guidance 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Guidelines for Dissolution Testing of Solid Oral Products Final Draft 1995, Pharmacopoeial Forum, 21 (5), 1371-1382, 1995Google Scholar
  2. 2.
    Guidance for Industry — Extended-Release Solid Oral Dosage Forms: Development, Evaluation and Application of in Vitro/in Vivo Correlations, Final Draft July 1, 1996. Food and Drug Administration.Google Scholar
  3. 3.
    New FIP Guideline for Dissolution Testing of Solid Oral Products, Dissolution Technologies 3 (3), 3-6, 1996.Google Scholar
  4. 4.
    Use of Dissolution Tests for Bioequivalence Assessment in Japan, Nobuo Aoyagi, Abstract, FIP Bio International 1996, 132-135.Google Scholar
  5. 5.
    Guideline for Bioequivalence Studies of Generic Drugs, Draft July 1, 1996, Ministry of Health and Welfare, National Institute of Health Sciences, Japan.Google Scholar

Copyright information

© Plenum Press, New York 1997

Authors and Affiliations

  • Henry J. Malinowski
    • 1
  1. 1.Division of Pharmaceutical Evaluation IOffice of Clinical Pharmacology and Biopharmaceutics Food and Drug Administration1451 RockvilleUSA

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