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Draft Guidance for Industry Extended-Release Solid Oral Dosage Forms

Development, Evaluation and Application of in Vitro-in Vivo Correlations
  • Henry Malinowski
  • Patrick Marroum
  • Venkata Ramana Uppoor
  • William Gillespie
  • Hae-Young Ahn
  • Peter Lockwood
  • James Henderson
  • Raman Baweja
  • Mohammad Hossain
  • Nicholas Fleischer
  • Lloyd Tillman
  • Ajaz Hussain
  • Vinod Shah
  • Angelica Dorantes
  • Ray Zhu
  • He Sun
  • Kofi Kumi
  • Stella Machado
  • Vijaya Tammara
  • Ting Eng Ong-Chen
  • Houda Mahayni
  • Lawrence Lesko
  • Roger Williams
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 423)

Abstract

This draft guidance provides recommendations to pharmaceutical scientists related to various aspects of in vitro/in vivo correlations (IVIVC) for oral extended-release (ER) drug products particularly as utilized in the NDA/ANDA review process. It presents a comprehensive perspective on methods of developing IVIVC, appropriate means of evaluating the predictability of IVIVC, and relevant applications for IVIVC in the areas of changes (e.g., formulation, equipment, process, and manufacturing site) and setting dissolution specifications. To access the final guidance on the WWW, connect to theFDA home page at http://www.fda.gov/CDER/ and go to the “Regulatory Guidance” section.

Keywords

Prediction Error Dosage Form Drug Product Dissolution Profile Dissolution Time 
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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Copyright information

© Plenum Press, New York 1997

Authors and Affiliations

  • Henry Malinowski
  • Patrick Marroum
  • Venkata Ramana Uppoor
  • William Gillespie
  • Hae-Young Ahn
  • Peter Lockwood
  • James Henderson
  • Raman Baweja
  • Mohammad Hossain
  • Nicholas Fleischer
  • Lloyd Tillman
  • Ajaz Hussain
  • Vinod Shah
  • Angelica Dorantes
  • Ray Zhu
  • He Sun
  • Kofi Kumi
  • Stella Machado
  • Vijaya Tammara
  • Ting Eng Ong-Chen
  • Houda Mahayni
  • Lawrence Lesko
  • Roger Williams

There are no affiliations available

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