Search results for ""author leon shargel""
Taylor & Francis Inc Generic Drug Product Development: Bioequivalence Issues
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.
£170.00
McGraw-Hill Education Shargel and Yu's Applied Biopharmaceutics & Pharmacokinetics
Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product.This authoritative guide has been updated with important new findings about drug therapy, product performance, and other need-to-know topicsApplied Biopharmaceutics & Pharmacokinetics, Eighth Edition delivers the knowledge and skills you need to succeed. The authors provide practical problems with specific examples of clinical solutions to help you apply principles to patient care and drug consultation situations. Each chapter includes objectives, summaries, and FAQs highlighting that help you understand and retain key concepts. You’ll learn how to derive models/parameters to describe drug absorption, distribution, and elimination processes; evaluate biopharmaceutic studies involving drug product equivalency and unequivalency; design and evaluate dosage regimens of drugs; detect and solve clinical pharmacokinetic problems; and much more.
£94.99
