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101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
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200 00$aNonclinical safety assessment$b[electronic resource] $ea guide to international pharmaceutical regulations /$fedited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown
210   $aChichester, West Sussex $cJohn Wiley & Sons$d2013
215   $a1 online resource (487 p.)
300   $aDescription based upon print version of record.
311   $a0-470-74591-6 
320   $aIncludes bibliographical references and index.
327   $aIntroduction to the development of drugs / Kathy McGown -- ICH / Ken Hastings -- USFDA / Bill Brock -- Latin America : MERCOSUR countries / Cristiana Leslie Corra -- Canada / Mark T. Goldberg -- EMEA / Adam Woolley -- Africa / Fariza Feraoun -- China / Lijie Fu -- Japan / Kazuichi Nakamura -- India / K.S. Rao -- Australia / Doug Francis -- Chronic repeat dose testing / Shana Azri-Meehan -- Carcinogenicity / James Popp -- Genotoxicity / Mark Powley -- Developmental and reproductive toxicology / Robert Parker -- Juvenile testing and pediatric claim / Melissa Tassinari -- Immunotoxicology / Leigh Ann Burns Naas -- Biologics / Chris Ellis -- Vaccines / Robert House -- Phototoxicity and photocarcinogenicity / Chris Sambuco -- Degradants, impurities excipients, and metabolites / Bob Osterberg.
330   $aBringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practi
606   $aDrug development$xInternational cooperation
606   $aDrugs$xToxicology$xInternational cooperation
615  0$aDrug development$xInternational cooperation.
615  0$aDrugs$xToxicology$xInternational cooperation.
676   $a615.1/901
701   $aBrock$b William J$0292040
701   $aHastings$b Kenneth L$0922449
701   $aMcGown$b Kathy M$0922450
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801  1$bMiAaPQ
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906   $aBOOK
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996   $aNonclinical safety assessment$92070026
997   $aUNINA