Specification of Drug Substances and Products Development and Validation of Analytical Methods By Christopher M. Riley Thomas W. Rosanske Shelley R. Rabel Riley

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Specification of Drug Substances and Products

Development and Validation of Analytical Methods

  • Christopher M. Riley
  • Thomas W. Rosanske
  • Shelley R. Rabel Riley

 

Elsevier

390

235 X 191

 

 

 This book 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.

 

Key Features

 

  • Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)
  • Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities
  • Direct applicability to the day-to-day activities in drug development and the potential to increase productivity

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.

 

 

Audience
For undergraduate pharmacy students and chemistry students; postgraduate students and faculty in analytical chemistry, pharmaceutical chemistry, pharmaceutical analysis, pharmaceutics and medicinal chemistry; analytical scientists in government, pharmaceutical industry and biotechnology industry and regulatory agencies.

 

 

Contents

  • Part One: Basic Concepts and Definitions
    1. Introduction
    2. General Principles and Regulatory Considerations: Specifications
    3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
    4. General Principles and Regulatory Considerations: Method Validation

      Part Two: Universal Tests
    5. Description and Identification
    6. Assay, and Impurities
    7. Residual Solvents
    8. Inorganic Impurities (Heavy Metals)

      Part Three: Specific Tests: Drug Substances
    9. Solid-State Characterization
    10. Chiral Methods
    11. Water Determination

      Part Four: Specific Tests: Drug Products
    12. Dissolution and Disintegration
    13. Extractables and Leachables
    14. Potency Assays for Biomolecules
    15. Host Cell Protein Assays

      Part Five: Pharmacopeial Methods
    16. Pharmacopeial Methods and Tests

      Part Six: Microbial Methods
    17. Sterile and Non-Sterile Products

      Part Seven: Biological Fluids
    18. Biological Fluids

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