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" Biosimilarity : "


Document Type : BL
Record Number : 852038
Main Entry : Niazi, Sarfaraz,1949-
Title & Author : Biosimilarity : : the FDA perspective /\ Sarfaraz K. Niazi.
Publication Statement : Boca Raton, FL :: CRC Press, Taylor & Francis,, [2019]
Page. NO : 1 online resource (xxxvii, 397 pages)
ISBN : 1315351374
: : 131536834X
: : 9781315351377
: : 9781315368344
: 1498750397
: 9781498750394
Bibliographies/Indexes : Includes bibliographical references and index.
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.
Subject : United States.
Subject : Drugs-- Generic substitution.
Subject : Pharmaceutical biotechnology-- United States.
Subject : Drugs-- Generic substitution.
Subject : MEDICAL / Pharmacology
Subject : Pharmaceutical biotechnology.
Subject : Biosimilar Pharmaceuticals.
Subject : Drug Approval.
Subject : Government Regulation.
Subject : United States Government Agencies.
Subject : United States.
Subject : United States.
Dewey Classification : ‭615.10973‬
LC Classification : ‭RS67.U6‬‭N53 2019eb‬
NLM classification : ‭2018 H-280‬
: ‭QV 241‬
copyhttps://lib.clisel.com/site/catalogue/852038
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