Specification of Drug Substances and Products: Development and Validation of Analytical Methods

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. 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 authoritiesDirect applicability to the day-to-day activities in drug development and the potential to increase productivity INDICE: Part One: Basic Concepts and Definitions Introduction General Principles and Regulatory Considerations: Specifications Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods General Principles and Regulatory Considerations: Method Validation Part Two: Universal Tests Description and Identification Assay, and Impurities Residual Solvents Inorganic Impurities (Heavy Metals) Part Three: Specific Tests: Drug Substances Solid-State Characterization Chiral Methods Water Determination Part Four: Specific Tests: Drug Products Dissolution and Disintegration Extractables and Leachables Potency Assays for Biomolecules Host Cell Protein Assays Part Five: Pharmacopeial Methods Pharmacopeial Methods and Tests Part Six: Microbial Methods Sterile and Non-Sterile Products Part Seven: Biological Fluids Biological Fluids

• ISBN: 978-0-08-098350-9
• Editorial: Elsevier
• Encuadernacion: Cartoné
• Páginas: 390
• Fecha Publicación: 17/09/2013
• Nº Volúmenes: 1
• Idioma: Inglés