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Generic Drug Product Development

Specialty Dosage Forms

Generic Drug Product Development( )
Author: Shargel, Leon
Kanfer, Isadore
ISBN:978-1-4200-2003-8
Publication Date:Apr 2016
Publisher:Taylor & Francis Group
Imprint:CRC Press
Book Format:Digital (delivered electronically)
List Price:USD $59.95
Book Description:

This volume 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 book discusses measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal...
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Book Details
Pages:288
Detailed Subjects: Medical / Pharmacology
Medical / Pharmacy



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