MARC Record from marc_columbia

LEADER: 05279cam a2200673Ii 4500
001 15117831
005 20210607113249.0
006 m o d
007 cr cnu---unuuu
008 170301s2017 flu ob 001 0 eng d
035 $a(OCoLC)ocn974040758
035 $a(NNC)15117831
040 $aN$T$beng$erda$epn$cN$T$dOCLCO$dIDEBK$dCRCPR$dOCLCO$dYDX$dOCLCF$dMERER$dOCLCQ$dOCLCO$dOCLCQ$dYDXIT$dOCLCO$dEBLCP$dUAB$dSTF$dEZ9$dU3W$dWYU$dLVT$dTYFRS$dUWO$dOCLCQ$dUKAHL$dOCLCQ$dOCLCO$dOCLCQ$dOCLCA$dOCLCQ
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020 $a9781498718806$q(electronic book)
020 $a1498718809$q(electronic book)
020 $a1315119870
020 $a9781315119878
020 $a9781351636650$q(e-book ;$qMobi)
020 $a1351636650
020 $a9781315119939$q(e-book)
020 $a1315119935
020 $z9781498718790
020 $z1498718795
024 7 $a10.1201/9781315119878$2doi
035 $a(OCoLC)974040758$z(OCoLC)974020002$z(OCoLC)974032980$z(OCoLC)974280322$z(OCoLC)974326666$z(OCoLC)974452532$z(OCoLC)974454099$z(OCoLC)974543963$z(OCoLC)974555983$z(OCoLC)974595500$z(OCoLC)974681966$z(OCoLC)974683702$z(OCoLC)974752855$z(OCoLC)974769010$z(OCoLC)974955843$z(OCoLC)974957711$z(OCoLC)975008466$z(OCoLC)975021400$z(OCoLC)1066494831$z(OCoLC)1069680611$z(OCoLC)1076752257
050 4 $aRM301.25$b.B56 2017
060 4 $aW1$bDR893B
060 4 $aQV 241
072 7 $aMED$x071000$2bisacsh
082 04 $a615.1/9$223
049 $aZCUA
245 00 $aBiosimilar drug product development /$cedited by Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow.
264 1 $aBoca Raton, FL :$bCRC Press,$c[2017]
300 $a1 online resource
336 $atext$btxt$2rdacontent
337 $acomputer$bc$2rdamedia
338 $aonline resource$bcr$2rdacarrier
490 1 $aDrugs and the pharmaceutical sciences
504 $aIncludes bibliographical references and index.
505 0 $aIntroduction : scientific factors in biosimilar drug product development / Laszlo Endrenyi, Paul Declerck, Shein-Chung Chow -- Analytical characterization : structural assessment of biosimilarity / Steven Berkowitz -- Analytical similarity assessment / Shein-Chung Chow, Li Liu -- Characterization of biosimilar biologics : the link between structure and functions / Roy Jefferis -- Manufacturing and process control issues -- quality development of biosimilar medicinal products / Alan Fauconnier, Lyudmil Antonov -- Animal studies / Karen de Smet, Leon van Aerts -- The clinical development of biosimilar drugs / Mark McCamish, Gillian R. Woollett, Sigrid Balser -- Statistical methods for biosimilarity / Shein-Chung Chow, Fuyu Song -- Extrapolation of indications / Jian Wang, Wallace Lauzon, Catherine Njue, Agnes V. Klein -- Interchangeability, switchability and substitution of biosimilars / Paul Declerck, Laszlo Endrenyi, Shein-Chung Chow -- Design and analysis of studies for assessing interchangeability / Shein-Chung Chow, Laszlo Endrenyi -- Role of immunogenicity evaluation for biosimilars / Paul Chamberlain -- Pharmacovigilance of biosimilars / Shehla Hashim, Souleh Semalulu, Felix Omara, Duc Vu -- Patent exclusivities affecting biosimilars in the United States, Canada and Europe / Lynn Tyler, Noel Courage -- Biosimilars in the EU : regulatory guidelines / Sol Ruiz -- Biosimilars and biologics : the prospects for competition / Erwin A. Blackstone, Joseph P. Fuhr, Jr. -- Plant-produced biosimilar products / Kenny K.Y. So, Michael R. Marit, J. Christopher Hall, Michael D. McLean.
588 0 $aOnline resource; title from digital title page (viewed on January 14, 2019).
520 2 $a"When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues."--Provided by publisher.
650 0 $aDrug development.
650 0 $aDrug approval.
650 12 $aBiosimilar Pharmaceuticals.
650 22 $aDrug Evaluation.
650 22 $aDrug Approval.
650 7 $aMEDICAL$xPharmacology.$2bisacsh
650 7 $aDrug approval.$2fast$0(OCoLC)fst00898661
650 7 $aDrug development.$2fast$0(OCoLC)fst00898670
655 4 $aElectronic books.
700 1 $aEndrenyi, Laszlo,$eeditor.
700 1 $aDeclerck, Paul$c(Professor in pharmaceutical sciences),$eeditor.
700 1 $aChow, Shein-Chung,$d1955-$eeditor.
776 08 $iPrint version:$tBiosimilar drug product development.$dBoca Raton : CRC Press, [2016]$z9781498718790$w(DLC) 2016038570$w(OCoLC)957634464
830 0 $aDrugs and the pharmaceutical sciences.
856 40 $uhttp://www.columbia.edu/cgi-bin/cul/resolve?clio15117831$zTaylor & Francis eBooks
852 8 $blweb$hEBOOKS