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Burdick, Richard K.

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry

Burdick, Richard K. - Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry, ebook

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ISBN: 9783319501864
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Table of contents

1. Introduction
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

2. Statistical Methods for CMC Applications
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

3. Process Design: Stage 1 of the FDA Process Validation Guidance
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

4. Process Qualification: Stage 2 of the FDA Process Validation Guidance
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

6. Analytical Procedures
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

7. Specifications
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

8. Stability
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

9. Analytical Comparability and Similarity
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

Keywords: Statistics, Statistics for Life Sciences, Medicine, Health Sciences, Pharmaceutical Sciences/Technology, Pharmacy

Author(s)
 
 
 
 
 
 
Publisher
Springer
Publication year
2017
Language
en
Edition
1
Series
Statistics for Biology and Health
Category
Natural Sciences
Format
Ebook
eISBN (PDF)
9783319501864
Printed ISBN
978-3-319-50184-0

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