The Handbook of Bioequivalence Testing provides a complete and timely description of every aspect of bioequivalence testing, including:

• worldwide regulatory requirements for filing for approval of generic drugs
• applying for a waiver
• securing regulatory approval of reports
• obtaining regulatory certification of facilities conducting bioequivalence studies...and more!

Features

• A practical, 'how-to' manual on bioequivalence testing, this guide describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations
• 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

Contents

1. Bioequivalence Testing
2. Regulatory Aspect of Bioequivalence Testing
3. Pharmacokinetic/Pharmacodynamic Modeling
4. Waiver of BA/BE Studies
5. Regulatory Review Process
6. Statistical Evaluation of Bioequivalence Data
7. Physicochemical Properties
8. Drug Delivery Factors
9. Bioanalytical Method Validation
10. Good Clinical Practice
11. Good Laboratory Practice for Nonclinical Lab Studies
12. Computer and Software Validations
13. Bioequivalence Reports

Index

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ORDER NOW Handbook of Bioequivalence Testing by Sarfaraz K. Niazi 2007 • 550 pages • $298.95 + shipping Texas residents please add 6.75 % sales tax