Release Date:23 Oct 2013

Imprint:Elsevier

Print Book

Pages:390

Dimensions: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.