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Book Cover
E-book
Author Niazi, Sarfaraz, 1949- author.

Title Biosimilars and interchangeable biologics : strategic elements / Sarfaraz K. Niazi
Published Boca Raton : CRC Press, 2016
©20

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Description 1 online resource
Series Online access with DDA: Askews (Medicine)
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
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Pharmaceutical biotechnology.
Biopharmaceutics.
Pharmaceutical industry -- Technological innovations.
Biologicals.
Biological products.
Biosimilar Pharmaceuticals -- standards
Biopharmaceutics
Biological Factors
Drug Approval
Drug Discovery -- standards
Drug Evaluation -- standards
Drug Industry -- standards
Biological Products
BUSINESS & ECONOMICS -- Industries -- General.
Biologicals
Biopharmaceutics
Pharmaceutical biotechnology
Pharmaceutical industry -- Technological innovations
Form Electronic book
ISBN 9781498743488
149874348X