Handbook of Bioequivalence Testing

Front Cover
CRC Press, Aug 22, 2007 - Medical - 550 pages
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As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing.

Features:

  • Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations
  • Discusses worldwide regulatory requirements for filing for approval of generic drugs
  • Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification
  • Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects
  • Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations
  • Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies
 

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Contents

Chapter 1 Bioequivalence Testing Rationale and Principles
1
Chapter 2 Regulatory Aspects of Bioequivalence Testing
45
Chapter 3 Pharmacokinetic and Pharmacodynamic Modeling
61
Chapter 4 Waiver of BioavailabilityBioequivalence Studies
69
Chapter 5 Regulatory Review Process
89
Chapter 6 Statistical Evaluation of Bioequivalence Data
119
Chapter 7 Physicochemical Properties Affecting Bioequivalence
163
Chapter 8 Drug Delivery Factors
197
Chapter 11 Good Laboratory Practices for Nonclinical Laboratory Studies
295
Chapter 12 Computer and Software Validation
317
Chapter 13 Bioequivalence Reports
339
Glossary of Terms
443
Bioequivalence Testing Literature
461
Dissolution Testing Methods of Approved Drugs
535
Index
553
Back cover
575

Chapter 9 Bioanalytical Method Validation
237
Chapter 10 Good Clinical Practice
265

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