Articles liés à Generic Drug Product Development: Bioequivalence Issues
Synopsis
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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À propos de l?auteur
Isadore Kanfer, Leon Shargel
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GENERIC DRUG PRODUCT DEVELOPMENT: BIOEQUIVALENCE ISSUES, DPSS. 180
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GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
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GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
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Edition internationale
GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
Edition internationaleVendeur : Basi6 International, Irving, TX, Etats-Unis
Évaluation du vendeur 5 sur 5 étoiles
Etat : Brand New. New.SoftCover International edition. Different ISBN and Cover image but contents are same as US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. N° de réf. du vendeur ABEJUNE24-401395
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GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
Edité par
TAYLOR & FRANCIS, 2008
ISBN 10 : 0849377846
ISBN 13 : 9780849377846
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Edition internationale
GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
Edité par
TAYLOR & FRANCIS, 2008
ISBN 10 : 0849377846
ISBN 13 : 9780849377846
Neuf
Couverture rigide
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Generic Drug Product Development
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Generic Drug Product Development : Bioequivalence Issues
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Generic Drug Product Development
Vendeur : PBShop.store UK, Fairford, GLOS, Royaume-Uni
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Generic Drug Product Development : Bioequivalence Issues
Edité par
CRC Press, 2007
ISBN 10 : 0849377846
ISBN 13 : 9780849377846
Ancien ou d'occasion
Couverture rigide
Vendeur : GreatBookPricesUK, Woodford Green, Royaume-Uni
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