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Handbook of Stability Testing in Pharmaceutical Development

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Cover of 'Handbook of Stability Testing in Pharmaceutical Development'

Table of Contents

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    Book Overview
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    Chapter 1 Introduction
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    Chapter 2 Critical Regulatory Requirements for a Stability Program
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    Chapter 3 Understanding ICH Guidelines Applicable to Stability Testing
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    Chapter 4 Global Stability Practices
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    Chapter 5 Post-approval Changes – Stability Requirements and Regulations
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    Chapter 6 Understanding and Predicting Pharmaceutical Product Shelf-Life
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    Chapter 7 Development of Stability Indicating Methods
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    Chapter 8 Method Validation and Transfer
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    Chapter 9 Overview of USP-NF Requirements for Stability Purposes
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    Chapter 10 Non-chromatographic Methods to Support Stability Program
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    Chapter 11 Vibrational Spectroscopic Methods for Quantitative Analysis
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    Chapter 12 Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product
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    Chapter 13 Evaluation of Stability Data
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    Chapter 14 Qualification, Calibration, and Maintenance of Stability Chambers
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    Chapter 15 Stability Operation Practices
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    Chapter 16 Combination Products/Drugs in Devices
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    Chapter 17 Stability Studies for Biologics
Attention for Chapter 2: Critical Regulatory Requirements for a Stability Program
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