Generic Drug Product Development - Bioequivalence Issues

Informationen zum Autor Isadore Kanfer, Leon Shargel Klappentext Generic pharmaceutical products must be approved as a therapeutic equivalent 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 This title focuses on bioequivalence issues and alternate approaches to demonstrate bioequivalence of generic drugs. Exploring scientific! legal! and international regulatory challenges! this source 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 chemical composition of the active drug and the nature of the drug product.. Zusammenfassung Generic Drug Product Development Inhaltsverzeichnis Introduction - Bioequivalence Issues. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Pharmaceutical Alternatives: Considerations for Generic Substitution. Pharmacodynamic Measurements for Determination of Bioequivalence. Bioequivalence Using Clinical Endpoint Studies. Evaluation of Bioequivalence of Highly-Variable Drug Products. Statistical Considerations: Alternate Designs And Approaches For Bioequivalence Assessments. Population Pharmacokinetic Approaches for Assessing Bioequivalence. Role of Metabolites in Bioequivalence Assessment. Implications of Chirality for the Assessment of Bioequivalence. Effect of Food on Bioavailability and the Assessment of Bioequivalence. Bioequivalence Assessment of Endogenous Drug Substances : Pharmacokinetics and Statistical Evaluation.

Product details

• Authors: Isadore Kanfer, Isadore (Rhodes University Kanfer, Isadore Shargel Kanfer, Kanfer Isadore, KANFER ISADORE SHARGEL LEON, Leon Shargel
• Assisted by: Isadore Kanfer (Editor), Leon Shargel (Editor)
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 15.11.2007
• EAN: 9780849377846
• ISBN: 978-0-8493-7784-6
• No. of pages: 288
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Pharmacy; Social sciences, law, business > Business > Individual industrial sectors, branches; SCIENCE / Chemistry / General, MEDICAL / Pharmacology, Biology, life sciences, Engineering: general, Pharmaceutical technology, Manufacturing industries, Pharmaceutical industries, Pharmaceutical chemistry and technology