Special Edition

Analytical Method Validation Vol. IV

Back for its fourth volume with even more topic areas to enhance your method validation procedures!

Dive into the use of the analytical target profile in the lifecycle of an analytical procedure, statistical analysis, analysis and control of variation to reduce analytical error, use of the Eurachem (Quam) guide on the analytical validation for inorganic anion analysis by capillary ion electrophoresis, and more.


Table of Contents

FDA SIgnals a New Approach for Analytical Method Validation by Tim Sandle

Aligning with the New Guidance: FDA Analytical Procedures and Method Validation by Ivan Soto

Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Validation by a USP Validation and Verification Expert Panel

The Use of the Analytical Target Profile in the Lifecycle of an Analytical Procedure: with an Example for an HPLC Procedure by Jane Weitzel, Robert A. Forbes, & Ronald D. Snee

Statistical Analytical in Analytical Method Validation by Eugenie Webster (Khlebnikova)

Quality-by-Design for Analytical Procedures: Decision Rules by Jane Weitzel

Analysis and Control of Variation: Understanding and Reducing Analytical Error by Bernard McGarvey, Brian K. Nunnally, & John McConnell

Use of the Eurachem (Quam) Guide on the Analytical Validation for Inorganic Anion Analysis by Capillary Ion Electrophoresis by Juan Carlos Raposo

Methodology for Assessing Product Inactiviation during Cleaning Part I: Experimental Approach and Analytical Methods by Rizwan Sharnez

Approaching Microbiological Method Validation by Tim Sandle

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