Riley Shelley R. Rabel (EN) — Specification of Drug Substances and Products

Тут можно читать онлайн книгу Riley Shelley R. Rabel (EN) - Specification of Drug Substances and Products - бесплатно полную версию (целиком). Жанр книги: Иностранная литература. Вы можете прочесть полную версию (весь текст) онлайн без регистрации и смс на сайте Lib-King.Ru (Либ-Кинг) или прочитать краткое содержание, аннотацию (предисловие), описание и ознакомиться с отзывами (комментариями) о произведении.

Specification of Drug Substances and Products
Язык книги: Английский
Прочитал книгу? Поставь оценку!
0 0

Specification of Drug Substances and Products краткое содержание

Specification of Drug Substances and Products - описание и краткое содержание, автор Riley Shelley R. Rabel (EN), читать бесплатно онлайн на сайте электронной библиотеки Lib-King.Ru.

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

Specification of Drug Substances and Products - читать онлайн бесплатно полную версию (весь текст целиком)

Specification of Drug Substances and Products - читать книгу онлайн бесплатно, автор Riley Shelley R. Rabel (EN)

Поделиться книгой

Оставить отзыв