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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 | ||
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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 | ||
| ||
Generic drug user fee amendments : accelerating patient access to generic drugs : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, second session ... January 28, 2016
| Generic drug user fee amendments : accelerating patient access to generic drugs : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, second session ... January 28, 2016 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2018 |
| Descrizione fisica | 1 online resource (ii, 39 pages) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
Generic drugs - Prices - United States
Drugs - Prices - United States Prescription pricing - United States Drug accessibility - Government policy - United States Drugs - Generic substitution Drug approval - United States Drug approval Drugs - Prices Generic drugs - Prices Prescription pricing |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Generic drug user fee amendments |
| Record Nr. | UNINA-9910706703803321 |
| Washington : , : U.S. Government Publishing Office, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Liste de médicaments : Drug list
| Liste de médicaments : Drug list |
| Pubbl/distr/stampa | [Quebec, : Quebec Health Insurance Board], 1973- |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Drugs - Prices - Québec (Province) - Periodicals
Drugs - Québec (Province) - Generic substitution - Periodicals Médicaments Médicaments - Prix - Québec (Province) - Périodiques Médicaments - Québec (Province) - Dénomination commune - Périodiques Drugs - Generic substitution Drugs - Prices |
| Soggetto genere / forma |
Electronic journals.
Periodicals. |
| Classificazione | cci1icc |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996207343903316 |
| [Quebec, : Quebec Health Insurance Board], 1973- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
Liste de médicaments : Drug list
| Liste de médicaments : Drug list |
| Pubbl/distr/stampa | [Quebec, : Quebec Health Insurance Board], 1973- |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Drugs - Prices - Québec (Province) - Periodicals
Drugs - Québec (Province) - Generic substitution - Periodicals Médicaments Médicaments - Prix - Québec (Province) - Périodiques Médicaments - Québec (Province) - Dénomination commune - Périodiques Drugs - Generic substitution Drugs - Prices |
| Soggetto genere / forma |
Electronic journals.
Periodicals. |
| Classificazione | cci1icc |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910144807203321 |
| [Quebec, : Quebec Health Insurance Board], 1973- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Rift-lines within European regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account / / Malik Osmane
| Rift-lines within European regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account / / Malik Osmane |
| Autore | Osmane Malik |
| Pubbl/distr/stampa | Hamburg, Germany : , : Anchor Academic Publishing, , 2014 |
| Descrizione fisica | 1 online resource (283 p.) |
| Disciplina | 572 |
| Soggetto topico |
Biological products
Drugs - Generic substitution Pharmaceutical biotechnology industry |
| Soggetto genere / forma | Electronic books. |
| ISBN | 3-95489-687-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account; Abstract; Table of Contents; Acknowledgements; List of abbreviations; Chapter 1.0: Introduction; 1.0. Rationale on the selection of the topic (as guide for future students); 1.1 Definitions; 1.2 Statement of the main problem, subsequent research questions and test-functions; 1.3 Study "Within Scope" and "Out of Scope"; 1.4 Description of the European Regulatory Environment with Regard to Biosimilars
1.5. Why are biosimilars interesting for the generic industry?Chapter 2.0: Literature review; 2.1. Re-presenting the current biosimilar legislation and regulatory requirements; 2.2 Life cycle in relation to heterogeneity and variation; 2.3 Screening the above presented literature related to current biosimilar regulation withregard to the research questions; 2.4. Reference to other biosimilar regulations; 2.2 Teil 2:Life cycle in relation to heterogeneity and variation 2.3 Teil 2: Screening the above presented literature related to current biosimilar regulation with regard to the research questions2.4. Teil 2:Reference to other biosimilar regulations (for informationalpurposes only); Chapter 3.0: Materials and Methods; 3.1 Methods used and rational for choosing them; 3.2 Rationale for using the employed research methodologies; 3.3 Practical aspects; Chapter 4.0: What are the implications of heterogeneity and variation through the life cycle of the biosimilar and the reference biologic, from a European perspective?; 4.1 Introduction 4.2 Experimental procedure (methods and materials) employed4.3 Results for main research questions 1.0 and directly associated research questions 1.1 and 1.2 that discuss the impact of the dynamic to the quality profile; 4.4 Discussion; Chapter 5.0: What should be the scope of trials?; 5.1 Introduction; 5.2 Experimental procedure (methods and materials) employed; 5.3 Results for the series 2 research questions; 5.4 Discussion; Chapter 6.0: Why is extrapolation of indications for biosimilar controversial?; 6.1 Introduction; 6.2 Experimental procedure (methods and materials) employed 6.3 Results from why is extrapolation of indications for biosimilar controversial?6.4 Discussion; Chapter 7.0 Integrated discussion; 7.1 Part I: General Comments; 7.2 Part II: Findings evaluation; 7.3 Part III: Discussion of solutions (and outlook); Chapter 8.0 Integrated conclusion; Bibliography or References; List of Appendices; Appendix: 1; Appendix: 2; Appendix: 3; Appendix: 4; Appendix: 5 |
| Record Nr. | UNINA-9910464060003321 |
|
Osmane Malik
|
||
| Hamburg, Germany : , : Anchor Academic Publishing, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Rift-lines within European regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account / / Malik Osmane
| Rift-lines within European regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account / / Malik Osmane |
| Autore | Osmane Malik |
| Pubbl/distr/stampa | Hamburg, Germany : , : Anchor Academic Publishing, , 2014 |
| Descrizione fisica | 1 online resource (283 p.) |
| Disciplina | 572 |
| Soggetto topico |
Biological products
Drugs - Generic substitution Pharmaceutical biotechnology industry |
| ISBN | 3-95489-687-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account; Abstract; Table of Contents; Acknowledgements; List of abbreviations; Chapter 1.0: Introduction; 1.0. Rationale on the selection of the topic (as guide for future students); 1.1 Definitions; 1.2 Statement of the main problem, subsequent research questions and test-functions; 1.3 Study "Within Scope" and "Out of Scope"; 1.4 Description of the European Regulatory Environment with Regard to Biosimilars
1.5. Why are biosimilars interesting for the generic industry?Chapter 2.0: Literature review; 2.1. Re-presenting the current biosimilar legislation and regulatory requirements; 2.2 Life cycle in relation to heterogeneity and variation; 2.3 Screening the above presented literature related to current biosimilar regulation withregard to the research questions; 2.4. Reference to other biosimilar regulations; 2.2 Teil 2:Life cycle in relation to heterogeneity and variation 2.3 Teil 2: Screening the above presented literature related to current biosimilar regulation with regard to the research questions2.4. Teil 2:Reference to other biosimilar regulations (for informationalpurposes only); Chapter 3.0: Materials and Methods; 3.1 Methods used and rational for choosing them; 3.2 Rationale for using the employed research methodologies; 3.3 Practical aspects; Chapter 4.0: What are the implications of heterogeneity and variation through the life cycle of the biosimilar and the reference biologic, from a European perspective?; 4.1 Introduction 4.2 Experimental procedure (methods and materials) employed4.3 Results for main research questions 1.0 and directly associated research questions 1.1 and 1.2 that discuss the impact of the dynamic to the quality profile; 4.4 Discussion; Chapter 5.0: What should be the scope of trials?; 5.1 Introduction; 5.2 Experimental procedure (methods and materials) employed; 5.3 Results for the series 2 research questions; 5.4 Discussion; Chapter 6.0: Why is extrapolation of indications for biosimilar controversial?; 6.1 Introduction; 6.2 Experimental procedure (methods and materials) employed 6.3 Results from why is extrapolation of indications for biosimilar controversial?6.4 Discussion; Chapter 7.0 Integrated discussion; 7.1 Part I: General Comments; 7.2 Part II: Findings evaluation; 7.3 Part III: Discussion of solutions (and outlook); Chapter 8.0 Integrated conclusion; Bibliography or References; List of Appendices; Appendix: 1; Appendix: 2; Appendix: 3; Appendix: 4; Appendix: 5 |
| Record Nr. | UNINA-9910787997303321 |
|
Osmane Malik
|
||
| Hamburg, Germany : , : Anchor Academic Publishing, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Rift-lines within European regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account / / Malik Osmane
| Rift-lines within European regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account / / Malik Osmane |
| Autore | Osmane Malik |
| Pubbl/distr/stampa | Hamburg, Germany : , : Anchor Academic Publishing, , 2014 |
| Descrizione fisica | 1 online resource (283 p.) |
| Disciplina | 572 |
| Soggetto topico |
Biological products
Drugs - Generic substitution Pharmaceutical biotechnology industry |
| ISBN | 3-95489-687-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account; Abstract; Table of Contents; Acknowledgements; List of abbreviations; Chapter 1.0: Introduction; 1.0. Rationale on the selection of the topic (as guide for future students); 1.1 Definitions; 1.2 Statement of the main problem, subsequent research questions and test-functions; 1.3 Study "Within Scope" and "Out of Scope"; 1.4 Description of the European Regulatory Environment with Regard to Biosimilars
1.5. Why are biosimilars interesting for the generic industry?Chapter 2.0: Literature review; 2.1. Re-presenting the current biosimilar legislation and regulatory requirements; 2.2 Life cycle in relation to heterogeneity and variation; 2.3 Screening the above presented literature related to current biosimilar regulation withregard to the research questions; 2.4. Reference to other biosimilar regulations; 2.2 Teil 2:Life cycle in relation to heterogeneity and variation 2.3 Teil 2: Screening the above presented literature related to current biosimilar regulation with regard to the research questions2.4. Teil 2:Reference to other biosimilar regulations (for informationalpurposes only); Chapter 3.0: Materials and Methods; 3.1 Methods used and rational for choosing them; 3.2 Rationale for using the employed research methodologies; 3.3 Practical aspects; Chapter 4.0: What are the implications of heterogeneity and variation through the life cycle of the biosimilar and the reference biologic, from a European perspective?; 4.1 Introduction 4.2 Experimental procedure (methods and materials) employed4.3 Results for main research questions 1.0 and directly associated research questions 1.1 and 1.2 that discuss the impact of the dynamic to the quality profile; 4.4 Discussion; Chapter 5.0: What should be the scope of trials?; 5.1 Introduction; 5.2 Experimental procedure (methods and materials) employed; 5.3 Results for the series 2 research questions; 5.4 Discussion; Chapter 6.0: Why is extrapolation of indications for biosimilar controversial?; 6.1 Introduction; 6.2 Experimental procedure (methods and materials) employed 6.3 Results from why is extrapolation of indications for biosimilar controversial?6.4 Discussion; Chapter 7.0 Integrated discussion; 7.1 Part I: General Comments; 7.2 Part II: Findings evaluation; 7.3 Part III: Discussion of solutions (and outlook); Chapter 8.0 Integrated conclusion; Bibliography or References; List of Appendices; Appendix: 1; Appendix: 2; Appendix: 3; Appendix: 4; Appendix: 5 |
| Record Nr. | UNINA-9910820224803321 |
|
Osmane Malik
|
||
| Hamburg, Germany : , : Anchor Academic Publishing, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
