272 pages | 67 B/W Illus.
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational approach to use, using realistic case studies, illustrations, and where appropriate, step-by-step protocols and procedures.
Foreword. Preface. Designing Experiments for Validation and Quantitative Methods. Validation of Chemical Reaction Processes. The Role of Designed Experiments in Validation and Process Analytical Technologies (PAT). Experimental Design for Bioassay Development and Validation. Use of Experimental Design Techniques in the Qualification and Validation of Plasma Protein Manufacturing Processes. Response Surface Methodology of Oral Dosage Forms. The Role of Designed Experiments in Developing and Validating Control Plans. Efficient and Effective Process Development Work: The Key to a Successful Validation Study