Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide off
Active Pharmaceutical Ingredients. Development, Manufacturing, and Regulation
โ Scribed by Stanley H. Nusim
- Publisher
- Marcel Dekker
- Year
- 2005
- Tongue
- English
- Leaves
- 354
- Series
- Drugs and the Pharmaceutical Sciences, Volume 151
- Edition
- Min. Library markings; no card P
- Category
- Library
No coin nor oath required. For personal study only.
๐ SIMILAR VOLUMES
This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.
The book reviews the history of current brand and generic business in pharmaceuticals manufacturing practices. Based on examples, the reader can interpolate, extrapolate and exploit mutual behavior (physical and chemical properties) of chemicals to design and commercialize processes that fulfi ll th