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This draft guidance provides recommendations to pharmaceutical scientists related to various aspects of in vitro/in vivo correlations (IVIVC) for oral extended-release (ER) drug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.
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© 1997 Plenum Press, New York
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Malinowski, H. et al. (1997). Draft Guidance for Industry Extended-Release Solid Oral Dosage Forms. In: Young, D., Devane, J.G., Butler, J. (eds) In Vitro-in Vivo Correlations. Advances in Experimental Medicine and Biology, vol 423. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-6036-0_25
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DOI: https://doi.org/10.1007/978-1-4684-6036-0_25
Publisher Name: Springer, Boston, MA
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