LEADER 04063nam 2200637 a 450 001 9910463352103321 005 20200520144314.0 010 $a0-674-07042-9 010 $a0-674-06796-7 024 7 $a10.4159/harvard.9780674067967 035 $a(CKB)2670000000330040 035 $a(StDuBDS)AH25018200 035 $a(SSID)ssj0000783256 035 $a(PQKBManifestationID)11416542 035 $a(PQKBTitleCode)TC0000783256 035 $a(PQKBWorkID)10752106 035 $a(PQKB)11066499 035 $a(MiAaPQ)EBC3301177 035 $a(DE-B1597)178013 035 $a(OCoLC)1004875437 035 $a(OCoLC)819323260 035 $a(OCoLC)840440989 035 $a(DE-B1597)9780674067967 035 $a(Au-PeEL)EBL3301177 035 $a(CaPaEBR)ebr10640099 035 $a(OCoLC)923119104 035 $a(EXLCZ)992670000000330040 100 $a20120411d2013 uy 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt 182 $cc 183 $acr 200 14$aThe fallacies of states' rights$b[electronic resource] /$fSotirios A. Barber 210 $aCambridge, Mass. $cHarvard University Press$d2013 215 $a1 online resource (245 pages) 300 $aBibliographic Level Mode of Issuance: Monograph 311 $a0-674-06667-7 320 $aIncludes bibliographical references and index. 327 $aIntroduction: America's oldest constitutional debate -- Why the states can't check national power -- John Marshall and a constitution for national security and prosperity -- The implications of Marshallian federalism -- Why states' rights federalism is impossible to defend -- John C. Calhoun's false theory of the Union -- States' rights as rights only to participate in national processes -- Why Marshallians should (but may not) win the states' rights debate. 330 $aThe idea that "states' rights" restrain national power is riding high in American judicial and popular opinion. Here, Sotirios A. Barber shows how arguments for states' rights, from the days of John C. Calhoun to the present, have offended common sense, logic, and bedrock constitutional principles. To begin with, states' rights federalism cannot possibly win the debate with national federalism owing to the very forum in which the requisite argument must occur-a national one, thanks to the Civil War-and the ordinary rules of practical argumentation. Further, the political consequences of this self-defeating logic can only hasten the loss of American sovereignty to international economic forces. Both philosophical and practical reasons compel us to consider two historical alternatives to states' rights federalism. In the federalism of John Marshall, the nation's most renowned jurist, the national government's duty to ensure security, prosperity, and other legitimate national ends must take precedence over all conflicting exercises of state power. In "process" federalism, the Constitution protects the states by securing their roles in national policy making and other national decisions. Barber opts for Marshall's federalism, but the contest is close, and his analysis takes the debate into new, fertile territory. Affirming the fundamental importance of the Preamble, Barber advocates a conception of the Constitution as a charter of positive benefits for the nation. It is not, in his view, a contract among weak separate sovereigns whose primary function is to protect people from the central government, when there are greater dangers to confront. 606 $aFederal government$zUnited States 606 $aStates' rights (American politics) 607 $aUnited States$xPolitics and government$xPhilosophy 608 $aElectronic books. 615 0$aFederal government 615 0$aStates' rights (American politics) 676 $a320.473/049 700 $aBarber$b Sotirios A$0595672 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910463352103321 996 $aThe fallacies of states' rights$92468496 997 $aUNINA 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