Validation of Analytical Methods for Biopharmaceuticals: A Guide to Risk-Based Validation and Implementation Strategies (single user digital version)

Apr 2007
PDA Item Number
PDF Single user
Member Price
Nonmember Price
Government Price

The book contains many new practical tips, tools and case studies that will allow validation scientists and management to make good risk-based decisions during planning, execution and post-implementation changes for all projects. This book is centered on what "sufficient performance" and "suitable for use" really mean for analytical methods. Dr. Krause will also answer the question, how can we measure risk and control this risk using well-designed validation studies. Currently, regulatory guidelines provide only basic guidance for analytical method validation. Dr. Krause's work builds on these basic regulatory guidance documents and provides several detailed validation practices, discussions and case studies on the best-possible strategies to assist readers to make good decisions

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 5.46 MB)

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents


Introduction (Click here to download >>>Introduction)

  1. Breaking It Down Into Pieces
  2. Analytical Method Development (AMD)
  3. Analytical Method Validation (AMV)
  4. Acceptance Criteria
  5. Analytical Method Comparability (AMC)
  6. Analytical Method Transfer (AMT)
  7. Analytical Method Maintenance (AMM)
  8. Dealing with Validation Failures
List of Acronyms

About the Authors

About the Author

Stephan O. Krause, PhD has a doctoral degree in analytical biochemistry from the University of Southern California and has been involved with analytical method validation for over eight years. Stephan has held leading roles in the area of analytical testing and validation for several pharmaceutical and biopharmaceutical firms in California. He is currently the Director of Quality Control at a biotech firm in San Diego, California.

Stephan is a popular lecturer and author. He has published more than a dozen articles on the topic of analytical method validation in highly respected industry journals. He often serves as session chair and lecturer at major conferences and also serves on several Editorial and Scientific Advisory Boards.