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

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

Table of Contents

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    Book Overview
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    Chapter 1 Introduction
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    Chapter 2 Statistical Methods for CMC Applications
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    Chapter 3 Process Design: Stage 1 of the FDA Process Validation Guidance
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    Chapter 4 Process Qualification: Stage 2 of the FDA Process Validation Guidance
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    Chapter 5 GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance
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    Chapter 6 Analytical Procedures
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    Chapter 7 Specifications
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    Chapter 8 Stability
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    Chapter 9 Analytical Comparability and Similarity
Attention for Chapter 4: Process Qualification: Stage 2 of the FDA Process Validation Guidance
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