Generic Drug Product Development Ebook

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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 Additional ISBNs 9780849377846 9780849377853 9781841848037 0849377846 0849377854 1841848034 9781282560970 9781420020021 1282560972 1420020021Generic Drug Product Development EbookBioequivalence Issues By Isadore Kanfer Publisher routledge Print ISBN 9780849377846 0849377846 eText ISBN 9781420020014 1420020013 Edition 1st Copyright year 2007 Format PDF Available from 2318 USD SKU 9781420020014R90 Downloaded copy on your device does not expire

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9780849377846

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 Additional ISBNs 9780849377846 9780849377853 9781841848037 0849377846 0849377854 1841848034 9781282560970 9781420020021 1282560972 1420020021Generic Drug Product Development EbookBioequivalence Issues By Isadore Kanfer Publisher routledge Print ISBN 9780849377846 0849377846 eText ISBN 9781420020014 1420020013 Edition 1st Copyright year 2007 Format PDF Available from 2318 USD SKU 9781420020014R90 Downloaded copy on your device does not expire