Автор: Martin D. Hynes
Название: Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, 2nd Edition
Издательство: CRC Press
Год: 2008
ISBN: 9780849391842; 0849391849
Серия: Drugs and the Pharmaceutical Sciences (Book 181)
Язык: English
Формат: pdf
Размер: 11,7 mb
Страниц: 304

The regulations that govern the development and manufacture of new drugs have evolved and changed since their advent in the early 1900s. In addition to official changes in the written regulations or laws that apply to the development and manufacturing of drugs, there have been changes in the interpretation of these regulations over time. During the past several decades, the interpretation and enforcement of these regulations have undergone dramatic alterations, significantly affecting the conduct of pharmaceutical research and development.

This book focuses on preparing for pre-approval inspections, in light of current trends in FDA expectations as well as enforcement activities with the goal of enhancing the chances of regulatory success thereby avoiding costly compliance issues. Various chapters concentrate on preparation for pre-approval inspections at the start of the drug development process as opposed to the final days before an FDA pre-approval inspection, regardless if it is conducted at a domestic or international site.