Автор: Leon Shargel, Isadore Kanfer
Название: Generic Drug Product Development: Solid Oral Dosage Forms, 2nd Edition
Издательство: CRC Press
Год: 2013
ISBN: 9781420086355
Серия: Drugs and the Pharmaceutical Sciences (Book 129)
Язык: English
Формат: pdf
Размер: 24,8 mb
Страниц: 370
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.
This second edition contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.