ENGLISH

Biosimilarity: the FDA perspective

By Niazi , Sarfaraz

Book information

Publisher
CRC Press
Year
2019
ISBN
9781498750394, 1498750397
Language
english
Format
PDF
Filesize
35 MB (36941381 bytes)
Pages
397\436
Time added
2019-04-14 09:00:00
United States. -- Food and Drug Administration.;Dr

Description

Content: 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.

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