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Generic Drugs

Generic Drug Product Development

Bioequivalence

Publication Date   June 2007
Publisher   Informa Healthcare
Product Type   Book
Pages   400
ISBN Number   978-0-8493-7784-6
Product Code   IFH093
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Price £115.00

approximately: $203 | €143

Summary


To be interchangeable with the brand name alternative, generic pharmaceutical products must demonstrate that they are its therapeutic equivalent. 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 measure plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed based upon the chemical component of the drug

Content


  • Introduction
  • Approved Drug Products with Therapeutic Equivalence Evaluations
  • Pharmaceutical Alternatives
  • Pharmacodynamic Measurements for Determination of Be
  • Bioequivalence Using Clinical Studies
  • Bioequivalence Assessment of Highly Variable Drugs
  • Highly Variable Drug Products-Simulation Studies
  • Population Pharmacokinetics and Approaches for The Assessment of Bioequivalence
  • Role of Metabolites in Bioequivalence Assessment
  • Isomerism and Chirality and Implications for The Assessment of Bioequivalence
  • Food Effects Studies
  • Bioequivalence Assessment for Drug Products Containing of Endogenous Drug Substances
  • in Vitro Bioequivalence Studies
  • Animal Models for Bioequivalence