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Pharmaceutical Validation Guide from C.H.I.P.S.

Pharmaceutical and Medical Device Validation by Experimental Design
edited by Lynn D. Torbeck

Pharmaceutical and Medical Device Validation by Experimental Design demonstrates how designed experiments are the most scientific, efficient, and cost effective methods of data collection for validation in a laboratory setting.

Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design uses realistic case studies, illustrations,
and step-by-step procols and procedures.

Features:

  • shows the function of designed experiments for process analytical technologies
  • illustrates the wide-range of applications for designed experiments
  • demonstrates the importance of well-organized process development work to ensure a successful validation study

Contents

  1. Designing Experiments for Validation and Quantitative Methods
  2. Validation of Chemical Reaction Processes
  3. The Role of Designed Experiments in Validation and Process Analytical Technologies (PAT)
  4. Experimental Design for Bioassay Development and Validation
  5. Use of Experimental Design Techniques in the Qualification and Validation of Plasma Protein Manufacturing Processes
  6. Response Surface Methodology of Oral Dosage Forms
  7. The Role of Designed Experiments in Developing and Validating Control Plans
  8. Efficient and Effective Process Development Work: The Key to a Successful Validation Study

Index

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Pharmaceutical and Medical Device
Validation by Experimental Design

edited by Lynn D. Torbeck
2007 272 pages $228.95 + shipping
Texas residents please add 6.75 % sales tax

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