Generic Drug Product Development: Specialty Dosage Forms 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.
| ISBN: | 9780367384395 |
| Publication date: | 15th October 2019 |
| Author: | Leon Shargel, Isadore Kanfer |
| Publisher: | CRC Press an imprint of Taylor & Francis Ltd |
| Format: | Paperback |
| Pagination: | 288 pages |
| Genres: |
Pharmaceutical chemistry and technology |
Generic Drug Product Development: Specialty Dosage Forms 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.
Generic Drug Product Development features in the following genres: Pharmaceutical chemistry and technology
Paperback, Ebook, Hardback. £63.89, down from the £70.99 cover price. Not Available.
Generic Drug Product Development was written by Leon Shargel, Isadore Kanfer and published by CRC Press an imprint of Taylor & Francis Ltd
Generic Drug Product Development has 288 pages
£63.89, reduced from £70.99. Not Available.