Chemistry, Manufacturing, and Controls in New Drug Applications

This title provides a useful how-to guide for practioners in the pharmaceutical industry who are navigating the FDA regulations for new drugs. Its coverage allows the user to develop the documentation needed to support changes before, during, and after the approval process, and provides recommended reporting categories.

Summary

This title provides a useful how-to guide for practioners in the pharmaceutical industry who are navigating the FDA regulations for new drugs. Its coverage allows the user to develop the documentation needed to support changes before, during, and after the approval process, and provides recommended reporting categories.

Product details

• Authors: Mukund S. Chorghade, Chorghade Mukund S.
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Hardback
• Released: 31.12.2015
• EAN: 9780470077955
• ISBN: 978-0-470-07795-5
• No. of pages: 380
• Subjects: Natural sciences, medicine, IT, technology > Chemistry; SCIENCE / Chemistry / General, chemistry, Chemical Engineering, Industrial chemistry & manufacturing technologies