Handbook of Analytical Validation
eBook - PDF

Handbook of Analytical Validation

  1. 220 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Handbook of Analytical Validation

Book details
Table of contents
Citations

About This Book

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analyti

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Yes, you can access Handbook of Analytical Validation by Michael E. Swartz, Ira S. Krull in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2012
ISBN
9781420014488
Edition
1
Topic
Medicine
Subtopic
Pharmacology

Table of contents

  1. Front Cover
  2. Contents
  3. Preface
  4. Chapter 1: Introduction to Analytical Method Validation
  5. Chapter 2: Analytical Instrument Qualification
  6. Chapter 3: HPLC Method Development and Optimization with Validation in Mind
  7. Chapter 4: Method Validation Basics
  8. Chapter 5: Robustness and System Suitability
  9. Chapter 6: Setting Specifications and Investigating Out-of-Specification Results
  10. Chapter 7: Validation by Type of Method
  11. Chapter 8: Analytical Method Transfer
  12. Chapter 9: Implementing New Technology in a Regulated Environment
  13. Glossary of Terms Related to Chromatographic Method Validation
  14. Appendix: Example Method Validation Protocol