| Document Type
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BL
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| Record Number
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599724
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| Doc. No
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b428943
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| Title & Author
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Generic drug product development : : bioequivalence issues /\ [edited by]Isadore Kanfer, Leon Shargel
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| Publication Statement
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New York :: Informa Healthcare,, c2008
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| Series Statement
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Drugs and the pharmaceutical sciences ;
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| Page. NO
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x, 264 p. :: ill. ;; 24 cm
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| ISBN
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9780849377846 (hardcover : alk. paper)
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: 0849377846 (hardcover : alk. paper)
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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Introduction-- bioequivalence issues / Isadore Kanfer and Leon Shargel -- Approved drug products with therapeutic equivalence evaluations (the orange book) / Loren Gelber -- Pharmaceutical alternatives : considerations for generic substitution / Roderick B. Walker, Roger K. Verbeeck, Isadore Kanfer -- Pharmacodynamic measurements for determination of bioequivalence / Manish Issar, Jeffrey G. Stark, and Leon Shargel --
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Bioequivalence using clinical endpoint studies / Christopher Hendy -- Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi -- Statistical considerations: alternate designs and approaches for bioequivalence assessments / Stanford Bolton and Charles Bon --
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Population pharmokinetic approaches for assessing bioequivalence / Philippe Colucci, Jean-Francois Marier, and Murray P. Ducharme -- Role of metabolites in bioequivalence assessent / André Jackson -- Implications of chirality for the assessment of bioequivalence / Reza Mehvar and Fakhreddin Jamali --
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Effect of food on bioavailability and the assessment of bioequivalence / Kim Dalhoff and Isadore Kanfer -- Bioequivalence assessment of endogenous drug substances: pharmacokinetics and statistical evaluation / Philippe Colucci ... [et al.]
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| Subject
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Drugs-- Therapeutic equivalency
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| Subject
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Drugs-- Bioavailability
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| Subject
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Generic drugs
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| Subject
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Drugs, Generic
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| Subject
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Biological Availability
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| Subject
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Therapeutic Equivalency
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| Dewey Classification
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615/.1
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| LC Classification
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RM301.45.G42 2008
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| NLM classification
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W1DR893B v.180 2008
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QV 38G3255 2008
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| Added Entry
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Kanfer, Isadore
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Shargel, Leon,1941-
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