Generic Drug Product Development Specialty Dosage Forms |
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| Author:
| Shargel, Leon
Kanfer, Isadore |
| ISBN: | 978-0-8493-7786-0 |
| Publication Date: | Mar 2010 |
| Publisher: | CRC Press LLC
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| Book Format: | Hardback |
| List Price: | USD $190.00 |
Book Description:
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Exploring the more difficult demonstration of pharmaceutical equivalence and bioequivalence for specialty drug products, this title details various approaches and strategies for manufacturers to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. It discusses the measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, generic biologics, and other drug products.
Exploring the more difficult demonstration of pharmaceutical equivalence and bioequivalence for specialty drug products, this title details various approaches and strategies for manufacturers to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. It discusses the measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, generic biologics, and other drug products.