| Autor: |
Ajaz S. Hussain, Patrick J. Marroum, Hae-Young Ahn, William R. Gillespie, Roger L. Williams, Ting Eng Ong-Chen, Angelica Dorantes, Lawrence J. Lesko, Lloyd G. Tillman, Vinod P. Shah, James Henderson, Ray Zhu, Peter Lockwood, Kofi Kumi, Mohammad Awlad Hossain, H. Malinowski, Nicholas Fleischer, He Sun, Vijaya Tammara, Houda Mahayni, Raman K. Baweja, Venkata Ramana Uppoor, Stella Machado |
| Rok vydání: |
1997 |
| Předmět: |
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| Zdroj: |
Advances in Experimental Medicine and Biology ISBN: 9781468460384 |
| Popis: |
This draft guidance provides recommendations to pharmaceutical scientists related to various aspects of in vitro/in vivo correlations (IVIVC) for oral extended-release (ER) drug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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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