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The Role of Metabolites in Bioequivalence

โœ Scribed by Kamal K. Midha; Maureen J. Rawson; John W. Hubbard


Book ID
111603659
Publisher
Springer US
Year
2004
Tongue
English
Weight
191 KB
Volume
21
Category
Article
ISSN
0724-8741

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We investigated the effects of dose and intrasubject variability (ISV) on bioequivalence (BE) of a parent drug with a single metabolite formed by nonlinear firstpass. A BE simulation was done using a four-compartment model at doses of 17.5, 35.0, and 70.0 mg. ISV was set at either 10% or 20% for cle