Biosimilarity : the FDA perspective /: the FDA perspective. ([2019])

• Record Type: Book
• Further Information: Note: Sarfaraz K. Niazi.
• Authors: Niazi, Sarfaraz, 1949-
• Contents: Understanding proteins -- The biosimilars landscape -- The FDA regulatory guidance -- Understanding biosimilarity -- Biopharmaceutical tools -- Critical quality attributes -- Safety similarity -- Formulation similarity -- Statistical modeling -- Biosimilarity : the final frontier.
• Publisher Details: Boca Raton, FL : CRC Press, Taylor & Francis
• Publication Date: 2019
• Extent: 1 online resource (xxxvii, 397 pages)
• Subjects: 615.10973; Drugs -- Generic substitution; Pharmaceutical biotechnology -- United States; Drugs -- Generic substitution; Pharmaceutical biotechnology; MEDICAL / Pharmacology; Biosimilar Pharmaceuticals; Drug Approval; Government Regulation; United States Government Agencies; United States; United States; Electronic books
• Languages: English
• ISBNs: 9781315351377; 1315351374
• Related ISBNs: 9781498750394; 1498750397
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.