Generic Drug Product Development

Author:   Leon Shargel, PhD, Rph (Applied Biopharmaceutics Applied Biopharmaceutics, Raleigh, North Carolina, USA Applied Biopharmaceutics, LLC, Raleigh, North Carolina, USA) ,  Isadore Kanfer (Rhodes University, Grahamstown, South Africa)
Publisher:   Informa Healthcare
ISBN:  

9781282560987


Pages:   291
Publication Date:   01 January 2010
Format:   Undefined
Availability:   In stock   Availability explained
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Generic Drug Product Development


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Overview

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.

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Author:   Leon Shargel, PhD, Rph (Applied Biopharmaceutics Applied Biopharmaceutics, Raleigh, North Carolina, USA Applied Biopharmaceutics, LLC, Raleigh, North Carolina, USA) ,  Isadore Kanfer (Rhodes University, Grahamstown, South Africa)
Publisher:   Informa Healthcare
Imprint:   Informa Healthcare
ISBN:  

9781282560987


ISBN 10:   1282560980
Pages:   291
Publication Date:   01 January 2010
Audience:   General/trade ,  General
Format:   Undefined
Publisher's Status:   Active
Availability:   In stock   Availability explained
We have confirmation that this item is in stock with the supplier. It will be ordered in for you and dispatched immediately.

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