Comprehensive quality by design for pharmaceutical product development and manufacture / / edited by Gintaras V. Reklaitis, Salvador Garcia-Munoz, Christine Seymour
| Comprehensive quality by design for pharmaceutical product development and manufacture / / edited by Gintaras V. Reklaitis, Salvador Garcia-Munoz, Christine Seymour |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2017 |
| Descrizione fisica | 1 online resource (397 pages) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drugs - Design
Pharmaceutical technology - Quality control |
| ISBN |
1-119-35617-2
1-119-35616-4 1-119-35618-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910270939003321 |
| Hoboken, New Jersey : , : Wiley, , 2017 | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Comprehensive quality by design for pharmaceutical product development and manufacture / / edited by Gintaras V. Reklaitis, Salvador Garcia-Munoz, Christine Seymour
| Comprehensive quality by design for pharmaceutical product development and manufacture / / edited by Gintaras V. Reklaitis, Salvador Garcia-Munoz, Christine Seymour |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2017 |
| Descrizione fisica | 1 online resource (397 pages) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drugs - Design
Pharmaceutical technology - Quality control |
| ISBN |
1-119-35617-2
1-119-35616-4 1-119-35618-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910811302803321 |
| Hoboken, New Jersey : , : Wiley, , 2017 | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad
| Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, N.J. : , : Wiley-Interscience, , 2008 |
| Descrizione fisica | 1 online resource (857 pages) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Pharmaceutical technology - Quality control
Pharmacy - Law and legislation - United States Drugs - Law and legislation - United States |
| ISBN |
1-281-23752-3
9786611237523 0-470-25983-3 0-470-25982-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES; 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines; 1.2 Enforcement of Current Good Manufacturing Practices; 1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations; 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells; SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES
2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences; SECTION 3 QUALITY; 3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems; 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment; 3.3 Creating and Managing a Quality Management System; 3.4 Quality Process Improvement; SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT); 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 4.2 Process Analytical Technology; 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology; SECTION 5 PERSONNEL; 5.1 Personnel Training in Pharmaceutical Manufacturing; SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL; 6.1 Origin of Contamination; 6.2 Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography-Tandem Mass Spectrometry; 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing; SECTION 7 DRUG STABILITY 7.1 Stability and Shelf Life of Pharmaceutical Products; 7.2 Drug Stability; 7.3 Effect of Packaging on Stability of Drugs and Drug Products; 7.4 Pharmaceutical Product Stability; 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics; SECTION 8 VALIDATION; 8.1 Analytical Method Validation: Principles and Practices; 8.2 Analytical Method Validation and Quality Assurance; 8.3 Validation of Laboratory Instruments; 8.4 Pharmaceutical Manufacturing Validation Principles; INDEX |
| Record Nr. | UNINA-9910785000603321 |
| Hoboken, N.J. : , : Wiley-Interscience, , 2008 | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad
| Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2008 |
| Descrizione fisica | 1 online resource (857 pages) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Pharmaceutical technology - Quality control
Pharmacy - Law and legislation - United States |
| ISBN |
9786611237523
9781281237521 1281237523 9780470259832 0470259833 9780470259825 0470259825 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES; 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines; 1.2 Enforcement of Current Good Manufacturing Practices; 1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations; 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells; SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES
2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences; SECTION 3 QUALITY; 3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems; 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment; 3.3 Creating and Managing a Quality Management System; 3.4 Quality Process Improvement; SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT); 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 4.2 Process Analytical Technology; 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology; SECTION 5 PERSONNEL; 5.1 Personnel Training in Pharmaceutical Manufacturing; SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL; 6.1 Origin of Contamination; 6.2 Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography-Tandem Mass Spectrometry; 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing; SECTION 7 DRUG STABILITY 7.1 Stability and Shelf Life of Pharmaceutical Products; 7.2 Drug Stability; 7.3 Effect of Packaging on Stability of Drugs and Drug Products; 7.4 Pharmaceutical Product Stability; 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics; SECTION 8 VALIDATION; 8.1 Analytical Method Validation: Principles and Practices; 8.2 Analytical Method Validation and Quality Assurance; 8.3 Validation of Laboratory Instruments; 8.4 Pharmaceutical Manufacturing Validation Principles; INDEX |
| Record Nr. | UNINA-9910955154003321 |
| Hoboken, N.J., : Wiley-Interscience, c2008 | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Quality assurance journal
| Quality assurance journal |
| Pubbl/distr/stampa | [Chichester], : John Wiley & Sons, ©1996-©2011 |
| Descrizione fisica | 1 online resource |
| Disciplina | 615 |
| Soggetto topico |
Pharmaceutical technology - Quality control
Medical instruments and apparatus industry - Quality control Pollution control industry - Quality control Medical care - Quality control Environmental Medicine - standards Health Occupations - standards Quality Assurance, Health Care Techniques pharmaceutiques - Qualité - Contrôle Médecine - Appareils et instruments - Industrie - Qualité - Contrôle Environnement - Industrie - Qualité - Contrôle Soins médicaux - Qualité - Contrôle Tecnologia farmacèutica Aparells i instruments mèdics Control de qualitat Control de processos Garantia de qualitat |
| Soggetto genere / forma |
Internet resource
Periodicals. Revistes electròniques. |
| ISSN | 1099-1786 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Qual Assur J
QA |
| Record Nr. | UNINA-9910555240803321 |
| [Chichester], : John Wiley & Sons, ©1996-©2011 | ||
| Lo trovi qui: Univ. Federico II | ||
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Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
| Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre |
| Pubbl/distr/stampa | Hoboken, : Wiley, c2009 |
| Descrizione fisica | 1 online resource (326 p.) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) |
MhatreRohin
RathoreAnurag S <1973-> (Anurag Singh) |
| Collana | Wiley Series in Biotechnology and Bioengineering |
| Soggetto topico |
Pharmaceutical biotechnology - Quality control
Pharmaceutical technology - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-118-21091-3
1-282-36843-5 9786612368431 0-470-46631-6 0-470-46630-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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
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 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 |
| Record Nr. | UNINA-9910139982903321 |
| Hoboken, : Wiley, c2009 | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
| Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre |
| Pubbl/distr/stampa | Hoboken, : Wiley, c2009 |
| Descrizione fisica | 1 online resource (326 p.) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) |
MhatreRohin
RathoreAnurag S <1973-> (Anurag Singh) |
| Collana | Wiley Series in Biotechnology and Bioengineering |
| Soggetto topico |
Pharmaceutical biotechnology - Quality control
Pharmaceutical technology - Quality control |
| ISBN |
1-118-21091-3
1-282-36843-5 9786612368431 0-470-46631-6 0-470-46630-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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
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 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 |
| Record Nr. | UNINA-9910831067203321 |
| Hoboken, : Wiley, c2009 | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Quality by design for biopharmaceuticals : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
| Quality by design for biopharmaceuticals : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre |
| Pubbl/distr/stampa | Hoboken, : Wiley, c2009 |
| Descrizione fisica | 1 online resource (326 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
MhatreRohin
RathoreAnurag S <1973-> (Anurag Singh) |
| Collana | Wiley Series in Biotechnology and Bioengineering |
| Soggetto topico |
Pharmaceutical biotechnology - Quality control
Pharmaceutical technology - Quality control |
| ISBN |
9786612368431
9781118210918 1118210913 9781282368439 1282368435 9780470466315 0470466316 9780470466308 0470466308 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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
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 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 |
| Record Nr. | UNINA-9911020439003321 |
| Hoboken, : Wiley, c2009 | ||
| Lo trovi qui: Univ. Federico II | ||
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Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou
| Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou |
| Autore | Zhou Michael |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
| Descrizione fisica | 1 online resource (548 p.) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical laboratories - Quality control
Biological laboratories - Quality control Pharmaceutical technology - Quality control |
| ISBN |
9786612889059
9780470922804 047092280X 9781282889057 1282889052 9780470920671 047092067X 9780470920664 0470920661 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
REGULATED BIOANALYTICAL LABORATORIES: Technical and Regulatory Aspects from Global Perspectives; CONTENTS; PREFACE; ACKNOWLEDGMENT; CONTRIBUTORS AND ADVISORS; 1 INTRODUCTION, OBJECTIVES, AND KEY REQUIREMENTS FOR GLP REGULATIONS; 1.1 INTRODUCTION; 1.1.1 Good Laboratory Practices; 1.1.2 Bioanalytical Laboratories-Bioanalysis; 1.1.3 Good Laboratory Practices Versus Bioanalytical Labs/Bioanalysis; 1.2 OBJECTIVES AND KEY REQUIREMENTS FOR GLP REGULATIONS; 1.3 FUNDAMENTAL UNDERSTANDING OF GLP REGULATIONS AND PRINCIPLES; 1.3.1 Elements of Good Laboratory Practices
1.4 KEY ELEMENTS OF BIOANALYTICAL METHODS VALIDATION1.4.1 Reference Standards; 1.4.2 Method Development-Chemical/Chromatographic Assay; 1.4.3 Calibration/Standard Curve; 1.4.4 Stability; 1.4.5 Reproducibility; 1.4.6 Robustness or Ruggedness; 1.5 BASIC PRINCIPLES OF BIOANALYTICAL METHOD VALIDATION AND ESTABLISHMENT; 1.5.1 Specific Recommendations for Method Validation; 1.5.2 Acceptance Criteria for Analytical Run; REFERENCES; 2 HISTORIC PERSPECTIVES OF GLP REGULATIONS, APPLICABILITY, AND RELATION TO OTHER REGULATIONS; 2.1 HISTORIC PERSPECTIVES OF GLP REGULATIONS; 2.1.1 Economic Assessment 2.1.2 Environmental Impact2.2 APPLICABILITY AND RELATIONS TO OTHER REGULATIONS/ PRINCIPLES; 2.2.1 GLP, GCP, GMP, and Part 11; 2.2.2 General Terminologies and Definitions of GxPs (GLP, GCP, and cGMP); 2.3 COMPARISON OF FDA GLP, EPA GLP REGULATIONS, AND OECD GLP PRINCIPLES; 2.3.1 US and OECD GLP Similarity and Differences; 2.4 APPLICATIONS OF GLP TO MULTIPLE SITE STUDIES; 2.4.1 Roles and Responsibilities; 2.4.2 Performance of the Studies; 2.4.3 Applications of GLP to In Vitro Studies for Regulatory Submissions; 2.5 21 CFR PART 11 IN RELATION TO GLP PROGRAMS; 2.5.1 A New Risk-Based Approach 2.5.2 Understanding Predicate Rule Requirements2.5.3 21 CFR Part 11 Best Practices; 2.5.4 Use of Electronic Signatures; 2.6 GLP, cGMP, AND ISO APPLICABILITIES, SIMILARITY, AND DIFFERENCES; 2.6.1 GLPs, cGMPs, ISO 17025:2005: How Do They Differ?; 2.6.2 GLPs Versus GMPs; 2.6.3 GLPs Versus ISO/IEC 17025:2005; 2.6.4 ISO Versus GLPs; 2.7 GOOD CLINICAL PRACTICES AND GOOD CLINICAL LABORATORY PRACTICES; 2.8 GAP AND CURRENT INITIATIVES ON REGULATING LABORATORY ANALYSIS IN SUPPORT OF CLINICAL TRIALS; REFERENCES; 3 GLP QUALITY SYSTEM AND IMPLEMENTATION; 3.1 GLP QUALITY SYSTEM 3.1.1 Regulatory Inspection for GLP Quality System3.1.2 Good Laboratory Practice Inspections; 3.1.3 GLP Quality System Objectives; 3.2 GLOBAL GLP REGULATIONS AND PRINCIPLES; 3.2.1 General; 3.2.2 Responsibilities and Compliance; 3.2.3 Statement of Compliance in the Final Report; 3.2.4 Protocol Approval; 3.2.5 Assignment of Study Director; 3.2.6 Laboratory Qualification/Certification; 3.2.7 Authority Inspections; 3.2.8 Archiving Requirements; 3.3 IMPLEMENTATION OF GLP REGULATIONS AND OECD PRINCIPLES; 3.3.1 Planning (Master Schedule); 3.3.2 Personnel Organization; 3.3.3 Curriculum Vitae 3.3.4 Rules of the Conducts of Studies |
| Record Nr. | UNINA-9911019143503321 |
Zhou Michael
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| Hoboken, N.J., : Wiley, c2011 | ||
| Lo trovi qui: Univ. Federico II | ||
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