Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2486471 | Journal of Pharmaceutical Sciences | 2010 | 5 Pages |
Abstract
Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30âmin) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15âmin) to be eligible for a biowaiver. Pharmacokinetic modeling of 32 BCS I drugs was performed to demonstrate that very rapid dissolution is not necessary to guarantee bioequivalence for them. Rapid dissolution and similar dissolution profiles are sufficient criteria for all BCS I drugs. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:621-625, 2010
Keywords
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Pharmacology, Toxicology and Pharmaceutical Science
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Authors
H. Kortejärvi, R. Shawahna, A. Koski, J. Malkki, K. Ojala, M. Yliperttula,