LEADER 01220nam1 22002653i 450 001 SUN0097579 005 20140417020916.813 010 $a88-14-01136-2$d0.00 100 $a20140415d1987 |0itac50 ba 101 $aita 102 $aIT 105 $a|||| ||||| 200 1 $aˆ1: ‰Borsa valori e agenti di cambio$fCesare Coltro Campi 210 $a2. ed. completamente rifatta Milano$cGiuffrè$d1987 215 $aVII, 280 p.$d25 cm. 410 1$1001SUN0032030$12001 $aRaccolta sistematica di giurisprudenza commentata. N. S$v5$1210 $aRimini$cMaggioli$a[poi] Milano$cGiuffrè$d1984-. 463 1$1001SUN0097578$12001 $aˆI ‰contratti di borsa nella giurisprudenza$fCesare Coltro Campi$v1$1205 $a 2. ed. completamente rifatta$1210 $aMilano$cGiuffrè$d1987$1215 $a3 v.$d25 cm. 620 $dMilano$3SUNL000284 700 1$aColtro Campi$b, Cesare$3SUNV057845$0112931 712 $aGiuffrè$3SUNV001757$4650 801 $aIT$bSOL$c20181231$gRICA 912 $aSUN0097579 950 $aUFFICIO DI BIBLIOTECA DEL DIPARTIMENTO DI ECONOMIA$d03PREST IVCf16(1) $e03 31667 1 20140415 996 $aBorsa valori e agenti di cambio$9885392 997 $aUNICAMPANIA LEADER 03732nam 2200637Ia 450 001 9910139982903321 005 20170816124341.0 010 $a1-118-21091-3 010 $a1-282-36843-5 010 $a9786612368431 010 $a0-470-46631-6 010 $a0-470-46630-8 035 $a(CKB)1000000000822020 035 $a(EBL)468996 035 $a(OCoLC)609847701 035 $a(SSID)ssj0000307444 035 $a(PQKBManifestationID)11277559 035 $a(PQKBTitleCode)TC0000307444 035 $a(PQKBWorkID)10244671 035 $a(PQKB)10992125 035 $a(MiAaPQ)EBC468996 035 $a(DLC) 2017285010 035 $a(EXLCZ)991000000000822020 100 $a20081030d2009 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aQuality by design for biopharmaceuticals$b[electronic resource] $eprinciples and case studies /$fedited by Anurag S. Rathore and Rohin Mhatre 210 $aHoboken $cWiley$dc2009 215 $a1 online resource (326 p.) 225 1 $aWiley Series in Biotechnology and Bioengineering ;$vv.1 300 $aDescription based upon print version of record. 311 $a0-470-28233-9 320 $aIncludes bibliographical references and index. 327 $aQUALITY BY DESIGN FOR BIOPHARMACEUTICALS; CONTENTS; Foreword; Preface; Preface to the Wiley Series on Biotechnology and Related Topics; Contributors; 1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS; 2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN; 3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris; 4 USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES; 5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP; 6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS 327 $a7 APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES8 VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE; 9 APPLICATION OF QUALITY BY DESIGN AND RISK ASSESSMENT PRINCIPLES FOR THE DEVELOPMENT OF FORMULATION DESIGN SPACE; 10 APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT; 11 QbD FOR RAW MATERIALS; 12 PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES; 13 EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY; Index 330 $aThe concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD 410 0$aWiley Series in Biotechnology and Bioengineering 606 $aPharmaceutical biotechnology$xQuality control 606 $aPharmaceutical technology$xQuality control 608 $aElectronic books. 615 0$aPharmaceutical biotechnology$xQuality control. 615 0$aPharmaceutical technology$xQuality control. 676 $a615.19 676 $a615/.19 701 $aMhatre$b Rohin$0949535 701 $aRathore$b Anurag S$g(Anurag Singh),$f1973-$0949536 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910139982903321 996 $aQuality by design for biopharmaceuticals$92146234 997 $aUNINA