Christopher M. Riley - Specification Of Drug Substances And Products: Development And Validation Of Analytical Methods
Descargar Specification Of Drug Substances And Products: Development And Validation Of Analytical Methods por Christopher M. Riley Epub y PDF
Christopher M. Riley con 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
Para un entusiasta de la lectura, es muy necesario identificar formatos comunes de libros electrónicos. El formato EPUB que se usa comúnmente en el mercado de libros electrónicos es un requisito previo que otros. Como los dispositivos de lectura y el software de Kobo, Nook y Sony son compatibles con los libros electrónicos en formato EPUB. Aquí puedes descargar el libro Specification Of Drug Substances And Products: Development And Validation Of Analytical Methods en epub y pdf.