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[null,"1.","Record Nr.",null,"UNIORUON00511710"]
[null,null,"Autore",null,"Littmann, Ennio"]
[null,null,"Titolo",null,"Nabataean Inscriptions from Egypt -2. / Enno Littmann ; with an introduction and Classical Notes by David Meredith"]
[null,null,"Pubbl/distr/stampa",null,"London, : University of London, 1953"]
[null,null,"Descrizione fisica",null,"P. 211-246 : ill. ; 25 cm"]
[null,null,"Disciplina",null,"939.4"]
[null,null,"Soggetti",null,"NABATEI - STORIA"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,"2.","Record Nr.",null,"UNINA9911020439003321"]
[null,null,"Titolo",null,"Quality by design for biopharmaceuticals : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre"]
[null,null,"Pubbl/distr/stampa",null,"Hoboken, : Wiley, c2009"]
[null,null,"ISBN",null,"9786612368431"]
[{"$nulls":4},"9781118210918"]
[{"$nulls":4},"1118210913"]
[{"$nulls":4},"9781282368439"]
[{"$nulls":4},"1282368435"]
[{"$nulls":4},"9780470466315"]
[{"$nulls":4},"0470466316"]
[{"$nulls":4},"9780470466308"]
[{"$nulls":4},"0470466308"]
[null,null,"Descrizione fisica",null,"1 online resource (326 p.)"]
[null,null,"Collana",null,"Wiley Series in Biotechnology and Bioengineering ; ; v.1"]
[null,null,"Disciplina",null,"615/.19"]
[null,null,"Soggetti",null,"Pharmaceutical biotechnology - Quality control"]
[{"$nulls":4},"Pharmaceutical technology - Quality control"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Description based upon print version of record."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"QUALITY BY DESIGN FOR BIOPHARMACEUTICALS; CONTENTS; Foreword; Preface; Preface to the Wiley Series on Biotechnology and Related Topics; Contributors; 1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS; 2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN; 3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris; 4 USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES; 5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP; 6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS"]
[{"$nulls":4},"7 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 "]
[{"$nulls":4},"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"]
[null,null,null,"Sommario/riassunto","The 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"]