Special Edition

Analytical Method Validation Volume III

The third edition in the series, Analytical Method Validation Volume III highlights application of method validation in the laboratory; implementation of process improvement strategies including QbD, PAT, LSS, DOE, and SPC; relevance of global method validation guidances and regulations; use of Monte Carlo Simulation; and validation of dissolution methods.

Table of Contents

Improvement Alphabet: Qbd, PAT, LSS, DOE, SPC—How do they Fit Together
Ronald D. Snee

Method Validation Studies: How GLP Interacts with Guidance Documents
Steven S. Kuwahara, Ph.D.

Reduction of Analytical Method Variability in an R&D Laboratory: A Case Study
Briank K. Nunnally, Andre Johnson, and Raymond Kaise

Method Validation (for Medical Devices)
Laure Larkin

Use of Monte Carlo Simulation to Address CMC Issues
Harry Yang, Ph.D.

Validation of Dissolution Methods
Gregory P. Martin and Vivian Gray

USP <1010> Analytical Data-Interpretaion and Treatment Appendix E: Comparison of Methods
Lynn Torbeck

Addressing Compliance Concerns During Dissolution Method Development, Validation, and Transfer
Gregory P. Martin and Vivian Gray

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