eBook Specification of Drug Substances and Products, 1st Edition

  • Published By:
  • ISBN-10: 008098343X
  • ISBN-13: 9780080983431
  • DDC: 615.1901
  • Grade Level Range: College Freshman - College Senior
  • 390 Pages | eBook
  • Original Copyright 2013 | Published/Released June 2014
  • This publication's content originally published in print form: 2013
  • Price:  Sign in for price



Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.

Table of Contents

Front Cover.
Half Title Page.
Title Page.
Copyright Page.
List of Contributors.
1: Introduction.
2: Introduction.
3: General Principles and Regulatory Considerations: Specifications.
4: Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods.
5: General Principles and Regulatory Considerations: Method Validation.
6: Universal Tests.
7: Description and Identification.
8: Assay and Impurities.
9: Residual Solvents.
10: Validation of Procedures for Elemental Impurities.
11: Specific Tests: Drug Substance.
12: Solid-State Characterization.
13: Chiral Methods.
14: Water Determination.
15: Specific Tests: Drug Product.
16: Dissolution.
17: Extractables and Leachables.
18: Pharmacopeial Methods.
19: Pharmacopeial Methods and Tests.
20: Microbial Methods.
21: Microbial Methods*.
22: Biological Fluids.
23: Bioanalytical Method Validation and Bioanalysis in Regulated Settings.