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portada Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences)
Type
Physical Book
Publisher
Language
English
Pages
288
Format
Paperback
ISBN13
9780367384395
Edition No.
1

Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences)

Leon Shargel; Isadore Kanfer (Author) · Crc Press · Paperback

Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences) - Leon Shargel; Isadore Kanfer

Physical Book

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Synopsis "Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences)"

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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The book is written in English.
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