Generic drug product development : bioequivalence issues /: bioequivalence issues. (©2008)

• Record Type: Book
• Further Information: Note: [edited by]Isadore Kanfer, Leon Shargel.
• Other Names: Kanfer, Isadore; Shargel, Leon, 1941-
• Contents: 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. 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. 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. 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 [and others].
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2008
• Copyright Date: 2008
• Extent: 1 online resource (x, 264 pages), illustrations
• Subjects: 615/.1; Drugs -- Therapeutic equivalency; Drugs -- Bioavailability; Generic drugs; Drugs, Generic; Biological Availability; Therapeutic Equivalency; MEDICAL -- Pharmacology; Drugs -- Bioavailability; Drugs -- Therapeutic equivalency; Generic drugs; Electronic books
• Languages: English
• ISBNs: 1420020013; 9781420020014
• Related ISBNs: 9780849377846; 0849377846
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.