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Biosimilars and interchangeable biologics : strategic elements / Sarfaraz K. Niazi
Material type:
TextPublisher: Boca Raton : CRC Press/Taylor & Francis Group, 2016Description: xlv, 599 pages : illustrations ; 29 cmContent type: - text
- unmediated
- volume
- 9781498743471 (hardcover : alk. paper)
- RS 380 .N53 2016 2024-7072
- QV 241
Contents:
Introduction to biosimilar and interchangeable products -- Intellectual property issues -- The EMA regulatory guidance -- EMA approved biosimilars -- The FDA regulatory guidance -- The ROW regulatory guidance -- US commercialization -- Global commercialization -- Quality and lifecycle management.
| Item type | Current library | Call number | Status | Date due | Barcode |
|---|---|---|---|---|---|
Books
|
1. KEMRI HQ Library | RS 380 .N53 2016 (Browse shelf(Opens below)) | Available | KMRI00521 |
Includes bibliographical references and index.
Introduction to biosimilar and interchangeable products -- Intellectual property issues -- The EMA regulatory guidance -- EMA approved biosimilars -- The FDA regulatory guidance -- The ROW regulatory guidance -- US commercialization -- Global commercialization -- Quality and lifecycle management.
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