Generic Drug Product Development (eBook, PDF) - Kanfer, Isadore; Shargel, Leon
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  • Format: PDF

Generic pharmaceutical products must be approved as a therapeutic equivalent to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure This title focuses on bioequivalence issues and alternate approaches to demonstrate bioequivalence of generic drugs. Exploring scientific, legal, and international regulatory challenges, this source discusses the use of alternative approaches to the measurement of…mehr

Produktbeschreibung
Generic pharmaceutical products must be approved as a therapeutic equivalent to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure This title focuses on bioequivalence issues and alternate approaches to demonstrate bioequivalence of generic drugs. Exploring scientific, legal, and international regulatory challenges, this source discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the chemical composition of the active drug and the nature of the drug product..

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