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Generic Drug Product Development: Specialty Dosage Forms.
・ISBN 978-0-367-38439-5 paper GB£ 70.99
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| 著者・編者 | Shargel, Leon / Kanfer, Isadore, |
|---|---|
| 出版社 | (CRC Press, UK) |
| 出版年月 | 2019 |
| ページ数 | 288 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A00-48422＞ |
解説
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.