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Biosimilars : design and analysis of follow-on biologics / / Shein-Chung Chow, Duke University School of Medicine, Durham, North Carolina, USA
| Biosimilars : design and analysis of follow-on biologics / / Shein-Chung Chow, Duke University School of Medicine, Durham, North Carolina, USA |
| Autore | Chow Shein-Chung <1955, > |
| Pubbl/distr/stampa | Boca Raton : , : Taylor & Francis, , 2014 |
| Descrizione fisica | 1 online resource (424 pages ) : illustrations |
| Disciplina | 615.19 |
| Collana | Chapman & Hall/CRC biostatistics series |
| Soggetto topico |
Pharmaceutical biotechnology
Pharmaceutical biotechnology industry Drugs - Generic substitution Pharmaceutical policy Biological products |
| ISBN |
0-429-07126-4
1-4665-7969-2 |
| Classificazione | MAT029000MED071000 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction Background Fundamental Differences Regulatory Requirements Biosimilarity Interchangeability of Biological Drug Products Scientific Factors Aim and Scope of the Book Bioequivalence Experience for Small-Molecule Drug Products Background Process for Bioequivalence Assessment Issue of Drug Interchangeability Highly Variable Drugs Practical Issues Frequently Asked Questions Regulatory Requirements for Assessing Follow-On Biologics Background Definitions and Interpretations of Biosimilar Products Regulatory Requirements Review of the FDA Draft Guidances Global Harmonization Criteria for Similarity Introduction Criteria for Bioequivalence Similarity Factor for Dissolution Profile Comparison Measures of Consistency Comparison of Moment-Based and Probability-Based Criteria Alternative Criteria Statistical Methods for Assessing Average Biosimilarity Introduction Classic Methods for Assessing Biosimilarity Bayesian Methods Wilcoxon-Mann-Whitney Two One-Sided Tests Procedure Three-Arm Parallel Design General Approach for Assessing Biosimilarity Background Reproducibility Probability Development of the Biosimilarity Index Relationship of the Biosimilarity Criterion versus Variability Biosimilarity Index Based on the Bayesian Approach Consistency Approach Non-Inferiority versus Equivalence/Similarity Background Testing for Equality Testing for Noninferiority Testing for Superiority Testing for Equivalence Relationship among Testing for Noninferiority, Superiority, and Equivalence Determination of the Noninferiority Margin Sample Size Requirement When There Is a Switch in Hypothesis Testing Statistical Test for Biosimilarity in Variability Introduction Pitman-Morgan's Adjusted Test for Comparing Variabilities F -Type Test under Parallel Design Non-Parametrics Methods Alternative Methods Sample Size for Comparing Variabilities Introduction Comparing Intra-Subject Variability Comparing Inter-Subject Variability Comparing Total Variability Comparing Intra-Subject CVs Impact of Variability on Biosimilarity Limits for Assessing Follow-On Biologics Introduction Relationship between Variability and Biosimilarity Limits Scaled Biosimilarity Margins Simulations Discussions Drug Interchangeability Introduction Population and Individual Bioequivalence Interchangeability for Biosimilar Products Study Designs for Interchangeability Statistical Methods Issues on Immunogenicity Studies Introduction Regulatory Requirements Assay Development/Validation Design for Immunogenicity Studies Sample Size for Immunogenicity Studies CMC Requirements for Biological Products Introduction CMC Development Product Characterization and Specification Manufacture and Process Validation Quality Control/Assurance Reference Standards, Container Closure System, and Stability Test for Comparability in Manufacturing Process Introduction Biologic Manufacturing Process Consistency Index Test for Comparability Other Comparability Tests Stability Analysis of Biosimilar Products Introduction Regulatory Stability Guidelines on Biologicals Stability Indicating Profile and Expiration Dating Period Stability Designs Statistical Analysis Assessing Biosimilarity Using Biomarker Data Introduction Assessment of Biosimilarity Statistical Test for Biosimilarity Using Biomarker Data Numerical Study Current Issues in Biosimilar Studies Introduction Scientific Factors Current Issues References Index |
| Record Nr. | UNINA-9910787329603321 |
Chow Shein-Chung <1955, >
|
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| Boca Raton : , : Taylor & Francis, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biosimilars : design and analysis of follow-on biologics / / Shein-Chung Chow
| Biosimilars : design and analysis of follow-on biologics / / Shein-Chung Chow |
| Autore | Chow Shein-Chung <1955-> |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Boca Raton, : Taylor & Francis, 2014 |
| Descrizione fisica | 1 online resource (424 pages ) : illustrations |
| Disciplina | 615.1/9 |
| Collana | Chapman & Hall/CRC biostatistics series |
| Soggetto topico |
Pharmaceutical biotechnology
Pharmaceutical biotechnology industry Drugs - Generic substitution Pharmaceutical policy Biological products |
| ISBN |
0-429-07126-4
1-4665-7969-2 |
| Classificazione | MAT029000MED071000 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction Background Fundamental Differences Regulatory Requirements Biosimilarity Interchangeability of Biological Drug Products Scientific Factors Aim and Scope of the Book Bioequivalence Experience for Small-Molecule Drug Products Background Process for Bioequivalence Assessment Issue of Drug Interchangeability Highly Variable Drugs Practical Issues Frequently Asked Questions Regulatory Requirements for Assessing Follow-On Biologics Background Definitions and Interpretations of Biosimilar Products Regulatory Requirements Review of the FDA Draft Guidances Global Harmonization Criteria for Similarity Introduction Criteria for Bioequivalence Similarity Factor for Dissolution Profile Comparison Measures of Consistency Comparison of Moment-Based and Probability-Based Criteria Alternative Criteria Statistical Methods for Assessing Average Biosimilarity Introduction Classic Methods for Assessing Biosimilarity Bayesian Methods Wilcoxon-Mann-Whitney Two One-Sided Tests Procedure Three-Arm Parallel Design General Approach for Assessing Biosimilarity Background Reproducibility Probability Development of the Biosimilarity Index Relationship of the Biosimilarity Criterion versus Variability Biosimilarity Index Based on the Bayesian Approach Consistency Approach Non-Inferiority versus Equivalence/Similarity Background Testing for Equality Testing for Noninferiority Testing for Superiority Testing for Equivalence Relationship among Testing for Noninferiority, Superiority, and Equivalence Determination of the Noninferiority Margin Sample Size Requirement When There Is a Switch in Hypothesis Testing Statistical Test for Biosimilarity in Variability Introduction Pitman-Morgan's Adjusted Test for Comparing Variabilities F -Type Test under Parallel Design Non-Parametrics Methods Alternative Methods Sample Size for Comparing Variabilities Introduction Comparing Intra-Subject Variability Comparing Inter-Subject Variability Comparing Total Variability Comparing Intra-Subject CVs Impact of Variability on Biosimilarity Limits for Assessing Follow-On Biologics Introduction Relationship between Variability and Biosimilarity Limits Scaled Biosimilarity Margins Simulations Discussions Drug Interchangeability Introduction Population and Individual Bioequivalence Interchangeability for Biosimilar Products Study Designs for Interchangeability Statistical Methods Issues on Immunogenicity Studies Introduction Regulatory Requirements Assay Development/Validation Design for Immunogenicity Studies Sample Size for Immunogenicity Studies CMC Requirements for Biological Products Introduction CMC Development Product Characterization and Specification Manufacture and Process Validation Quality Control/Assurance Reference Standards, Container Closure System, and Stability Test for Comparability in Manufacturing Process Introduction Biologic Manufacturing Process Consistency Index Test for Comparability Other Comparability Tests Stability Analysis of Biosimilar Products Introduction Regulatory Stability Guidelines on Biologicals Stability Indicating Profile and Expiration Dating Period Stability Designs Statistical Analysis Assessing Biosimilarity Using Biomarker Data Introduction Assessment of Biosimilarity Statistical Test for Biosimilarity Using Biomarker Data Numerical Study Current Issues in Biosimilar Studies Introduction Scientific Factors Current Issues References Index |
| Record Nr. | UNINA-9910822825703321 |
|
Chow Shein-Chung <1955->
|
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| Boca Raton, : Taylor & Francis, 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biosimilars handbook [[electronic resource]]
| Biosimilars handbook [[electronic resource]] |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | [London], : SAGE, 2011 |
| Descrizione fisica | 1 online resource (56 p.) |
| Disciplina | 615.19 22 |
| Soggetto topico |
Pharmaceutical biotechnology
Pharmaceutical biotechnology industry Drugs - Generic substitution Pharmaceutical policy Biological products |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-4462-0896-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Front Cover ""; ""Contents""; ""Introduction ""; ""What this handbook covers ""; ""Whom this handbook for ""; ""Executive Summary ""; ""The importance of biosimilar medicines""; ""The health economic benefits from biosimilar medicines""; ""Nomenclature of biopharmaceuticals, including biosimilar medicines""; ""List of European Commission-approved biosimilar medicines""; ""The science and technology of biosimilar medicines""; ""Regulation of biosimilar medicines""; ""Introduction of biosimilar medicines into clinical practice""; ""The future and evolving landscape of biosimilar medicines""
""Further information""""Contributors""; ""Glossary""; ""Acronyms and Abbreviations""; ""Appendix""; ""Back Cover"" |
| Record Nr. | UNINA-9910465297803321 |
| [London], : SAGE, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Making sense : markets from stories in new breast cancer therapeutics / / Sophie Mützel
| Making sense : markets from stories in new breast cancer therapeutics / / Sophie Mützel |
| Autore | Mützel Sophie |
| Edizione | [First edition.] |
| Pubbl/distr/stampa | Stanford, California : , : Stanford University Press, , [2023] |
| Descrizione fisica | 1 online resource (222 pages) |
| Disciplina | 616.99449061 |
| Collana | Culture and economic life |
| Soggetto topico |
Pharmaceutical biotechnology industry
Breast - Cancer - Treatment - Technological innovations Breast - Cancer - Treatment - Economic aspects Drug development - Economic aspects Narration (Rhetoric) - Economic aspects Narration (Rhetoric) - Social aspects Markets - Social aspects |
| ISBN | 1-5036-3407-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Frontmatter -- Contents -- Acknowledgments -- Introduction -- 1 Markets and Stories -- 2 Breast Cancer Therapies and Innovation -- 3 A Market of Expectations -- 4 Making Sense of the Market -- 5 Patterns in Meaning-Making: Categories over Time -- Conclusion: Markets from Stories -- Appendix A: Research Design and Data -- Appendix B: Technical Details on Formal Analyses -- Notes -- Bibliography -- Index |
| Record Nr. | UNINA-9910795981103321 |
|
Mützel Sophie
|
||
| Stanford, California : , : Stanford University Press, , [2023] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Making sense : markets from stories in new breast cancer therapeutics / / Sophie Mützel
| Making sense : markets from stories in new breast cancer therapeutics / / Sophie Mützel |
| Autore | Mützel Sophie |
| Edizione | [First edition.] |
| Pubbl/distr/stampa | Stanford, California : , : Stanford University Press, , [2023] |
| Descrizione fisica | 1 online resource (222 pages) |
| Disciplina | 616.99449061 |
| Collana | Culture and economic life |
| Soggetto topico |
Pharmaceutical biotechnology industry
Breast - Cancer - Treatment - Technological innovations Breast - Cancer - Treatment - Economic aspects Drug development - Economic aspects Narration (Rhetoric) - Economic aspects Narration (Rhetoric) - Social aspects Markets - Social aspects |
| ISBN | 1-5036-3407-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Frontmatter -- Contents -- Acknowledgments -- Introduction -- 1 Markets and Stories -- 2 Breast Cancer Therapies and Innovation -- 3 A Market of Expectations -- 4 Making Sense of the Market -- 5 Patterns in Meaning-Making: Categories over Time -- Conclusion: Markets from Stories -- Appendix A: Research Design and Data -- Appendix B: Technical Details on Formal Analyses -- Notes -- Bibliography -- Index |
| Record Nr. | UNINA-9910814581603321 |
|
Mützel Sophie
|
||
| Stanford, California : , : Stanford University Press, , [2023] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Microbiology independent research journal
| Microbiology independent research journal |
| Pubbl/distr/stampa | St. Petersburg, Russia : , : Doctrine LLC. |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Pharmaceutical industry
Pharmaceutical biotechnology industry |
| Soggetto genere / forma | Periodicals. |
| ISSN | 2500-2236 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | MIR journal |
| Record Nr. | UNINA-9910503510203321 |
| St. Petersburg, Russia : , : Doctrine LLC. | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Microbiology independent research journal
| Microbiology independent research journal |
| Pubbl/distr/stampa | St. Petersburg, Russia : , : Doctrine LLC. |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Pharmaceutical industry
Pharmaceutical biotechnology industry |
| Soggetto genere / forma | Periodicals. |
| ISSN | 2500-2236 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | MIR journal |
| Record Nr. | UNISA-996442353303316 |
| St. Petersburg, Russia : , : Doctrine LLC. | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Oceans and human health : implications for society and well-being / / edited by Robert E. Bowen [and three others]
| Oceans and human health : implications for society and well-being / / edited by Robert E. Bowen [and three others] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (320 p.) |
| Disciplina | 577.7 |
| Soggetto topico |
Marine biology
Marine plants Marine biotechnology Pharmaceutical biotechnology industry Public health |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-11728-3
1-118-82844-5 1-118-82839-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title Page; Copyright; Contents; List of Contributors; Foreword; About the Companion Website; Section One Coastal Seas, Human Health, and Well-Being: Setting the Stage; Chapter 1 Influences of the Oceans on Human Health and Well-Being; 1.1 Introduction; 1.2 Interactions and routes of exposure; 1.3 Risks; 1.4 Benefits; 1.5 Discussion; Acknowledgments; References; Chapter 2 Integrating Frameworks to Assess Human Health and Well-Being in Marine Environmental Systems; 2.1 Introduction; 2.2 Integration, complexity, and need for new frameworks; 2.3 Background
2.4 Integrating frameworks for human health and well-being2.5 Assessing the influences on environmental change; 2.6 The Driver-Pressure-State-Impact-Response framework; 2.7 The Driver-Pressure-State-Exposure-Effect-Action framework; 2.8 The DPSIR in the case-study literature; 2.9 The DPSEEA in the case-study literature; 2.10 Flexibility in applying frameworks; 2.11 Conclusion; References; Section Two Anthropogenic Drivers/Pressures and the State of Coastal Seas; Chapter 3 Coastal Demography: Distribution, Composition, and Dynamics; 3.1 Introduction; 3.2 Background 3.3 Summary and conclusions: interdisciplinary applications in the decades aheadAcknowledgments; References; Chapter 4 The Seas, Ecosystem Services, and Human Well-Being; 4.1 Introduction; 4.2 Background: ecosystem services explained; 4.3 Sources of change in marine ecosystem services; 4.4 Managing marine ecosystems for human health and well-being; 4.5 Summary and conclusions; References; Chapter 5 Measuring Social Value and Human Well-Being; 5.1 Introduction; 5.2 Background; 5.3 Summary and conclusions; References; Section Three Impacts on Coastal Environments Chapter 6 The Impact of Climate Change on Coastal Ecosystems6.1 Introduction; 6.2 Background; 6.3 Summary and conclusions; References; Chapter 7 Coastal Systems and Access to Safe and Potable Water; 7.1 Introduction; 7.2 Background; 7.3 Challenges to society for addressing these concerns and mitigating the consequences; 7.4 Rethinking water governance; 7.5 Decentralization and participatory decision making in water governance; 7.6 Moving forward; References; Section Four Responses; Chapter 8 Management-Driven Assessments of the Coastal Oceans; 8.1 Introduction; 8.2 Background 8.3 The global ocean observing system and integrated ecosystem assessments8.4 Ocean observing for human health and well-being; 8.5 Building an integrated system of systems; 8.6 Summary and conclusions; References; Chapter 9 Globalization and Human Health: Regulatory Response and the Potential for Reform; 9.1 Introduction; 9.2 Background; 9.3 Rethinking global governance; 9.4 Future and conclusions; References; Section Five Common Conclusions and Horizon Scanning; Chapter 10 Emerging Issues in Oceans and Human Health: Managing Uncertainty and New Knowledge; 10.1 Introduction 10.2 Approaches to identifying and tracking emerging issues in oceans and health: horizon scanning |
| Record Nr. | UNINA-9910453442603321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Oceans and human health : implications for society and well-being / / edited by Robert E. Bowen [and three others]
| Oceans and human health : implications for society and well-being / / edited by Robert E. Bowen [and three others] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (320 pages) : illustrations (some color) |
| Disciplina | 577.7 |
| Soggetto topico |
Marine biology
Marine plants Marine biotechnology Pharmaceutical biotechnology industry Public health |
| ISBN |
1-118-82844-5
1-119-11728-3 1-118-82839-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910795806203321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Oceans and human health : implications for society and well-being / / edited by Robert E. Bowen [and three others]
| Oceans and human health : implications for society and well-being / / edited by Robert E. Bowen [and three others] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (320 pages) : illustrations (some color) |
| Disciplina | 577.7 |
| Soggetto topico |
Marine biology
Marine plants Marine biotechnology Pharmaceutical biotechnology industry Public health |
| ISBN |
1-118-82844-5
1-119-11728-3 1-118-82839-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910821291403321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
