Автор: Isadore Kanfer and Leon Shargel
Название: Generic Drug Product Development: Bioequivalence Issues
Издательство: CRC Press
Год: 2008
ISBN: 0849377846; 9780849377846
Серия: Drugs and the Pharmaceutical Sciences (Book 180)
Язык: English
Формат: pdf
Размер: 11,6 mb
Страниц: 288

The book explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives.

The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.

The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.