| Generic Drug Product Development: Specialty Dosage Forms Contributor(s): Shargel, Leon (Author), Kanfer, Isadore (Author) |
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ISBN: 0849377862 ISBN-13: 9780849377860 Publisher: CRC Press OUR PRICE: $209.00 Product Type: Hardcover - Other Formats Published: March 2010 |
| Additional Information |
| BISAC Categories: - Medical | Pharmacology - Medical | Pharmacy - Science | Chemistry - General |
| Dewey: 615.19 |
| LCCN: 2009045723 |
| Series: Drugs and the Pharmaceutical Sciences |
| Physical Information: 0.9" H x 6.1" W x 9.1" (1.15 lbs) 288 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: 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. |