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Generic Drug Product Development: Bioequivalence Issues (Drugs and the Pharmaceutical Sciences, 180, Band 180) - Hardcover

Kanfer, Isadore; Shargel, Leon

 
9780849377846: Generic Drug Product Development: Bioequivalence Issues (Drugs and the Pharmaceutical Sciences, 180, Band 180)
Hardcover
ISBN 10: 0849377846 ISBN 13: 9780849377846
Verlag: CRC Press, 2010

Inhaltsangabe

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents 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. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, 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 physical and chemical properties of the active drug and the nature of the drug product.

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Über die Autorin bzw. den Autor

Isadore Kanfer, Leon Shargel

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Verlag
CRC Press
Erscheinungsdatum
2010
Sprache
Englisch
ISBN 10 
0849377846
ISBN 13 
9780849377846
Einband
Gebundene Ausgabe
Auflage
1
Anzahl der Seiten
264
Kontakt zum Hersteller
CRC Press
https://www.routledge-ny.com

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