Biosimilar Drug Product Development

Biosimilar Drug Product Development


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Product Details

ISBN-13: 9781498718790
Publisher: Taylor & Francis
Publication date: 03/07/2017
Series: Drugs and the Pharmaceutical Sciences Series
Pages: 487
Product dimensions: 6.12(w) x 9.25(h) x (d)

Table of Contents

Analytical characterization. Immunogenicity. Animal studies. Clinical development. Manufacturing, process control. Extrapolation of indications. Interchangeability, substitution. Pharmacovigilance. Statistical issues. Regulatory issues.

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