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An Act to Amend the Federal Food, Drug, and Cosmetic Act with Respect to the Scope of New Chemical Exclusivity
| An Act to Amend the Federal Food, Drug, and Cosmetic Act with Respect to the Scope of New Chemical Exclusivity |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2021] |
| Descrizione fisica | 1 online resource (4 unnumbered pages) |
| Soggetto topico |
Drug approval - United States
Pharmaceutical policy - United States Drug approval Pharmaceutical policy |
| Soggetto genere / forma | Statutes and codes. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910716073503321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Annual report / / Patented Medicine Prices Review Board
| Annual report / / Patented Medicine Prices Review Board |
| Pubbl/distr/stampa | [Ottawa], : Patented Medicine Prices Review Board, [199-]- |
| Disciplina | 353.9/98285/097105 |
| Soggetto topico |
Drugs - Prices - Canada
Patents - Canada Pharmaceutical policy - Canada Pharmacy - Research - Canada Drugs - Research - Canada Médicaments - Prix - Canada Brevets d'invention - Canada Médicaments - Politique gouvernementale - Canada Médicaments - Recherche - Canada Drugs - Research Drugs - Prices Patents Pharmaceutical policy Pharmacy - Research |
| Soggetto genere / forma | Periodicals |
| Classificazione |
cci1icc
coll11 coll14 coll29 coll108 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | PMPRB annual report |
| Record Nr. | UNINA-9910892804103321 |
| [Ottawa], : Patented Medicine Prices Review Board, [199-]- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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 |
1-04-018910-5
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-9910971108603321 |
|
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 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 | ||
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Center for Drug Evaluation and Research update
| Center for Drug Evaluation and Research update |
| Pubbl/distr/stampa | [Silver Spring, MD], : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] |
| Descrizione fisica | 1 online resource |
| Disciplina | 615 |
| Soggetto topico |
Drugs - United States - Testing
Pharmaceutical policy - United States Drug approval - United States Drug Approval Drug Industry Drug approval Drugs - Testing Pharmaceutical policy |
| Soggetto genere / forma |
Statistics
Periodicals. Statistics. |
| ISSN | 2150-2390 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Update
CDER ... update Improving public health through human drugs |
| Record Nr. | UNINA-9910702844903321 |
| [Silver Spring, MD], : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The cost of prescription drugs : examining the President's blueprint 'American Patients First' to lower drug prices : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, second session, on examining the cost of prescription drugs, focusing on examining the President's blueprint 'American Patients First' to lower drug prices, June 12, 2018
| The cost of prescription drugs : examining the President's blueprint 'American Patients First' to lower drug prices : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, second session, on examining the cost of prescription drugs, focusing on examining the President's blueprint 'American Patients First' to lower drug prices, June 12, 2018 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2020 |
| Descrizione fisica | 1 online resource (iii, 41 pages) |
| Collana | S. hrg. |
| Soggetto topico |
Drugs - United States - Cost control
Pharmaceutical policy - United States Prescription pricing - United States Drugs - Cost control Pharmaceutical policy Prescription pricing |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Cost of Prescription Drugs |
| Record Nr. | UNINA-9910714807303321 |
| Washington : , : U.S. Government Publishing Office, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Curbing prescription drug abuse in Medicare : hearing before the Committee on Homeland Security and Governmental Affairs, United States Senate, One Hundred Thirteenth Congress, first session, June 24, 2013
| Curbing prescription drug abuse in Medicare : hearing before the Committee on Homeland Security and Governmental Affairs, United States Senate, One Hundred Thirteenth Congress, first session, June 24, 2013 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2014 |
| Descrizione fisica | 1 online resource (iii, 131 pages) |
| Collana | S. hrg. |
| Soggetto topico |
Drugs - Prescribing - Corrupt practices - United States
Medication abuse - United States - Prevention Medicare fraud - Prevention Medicaid fraud - Prevention Pharmaceutical policy - United States Drugs - Prescribing - Corrupt practices Medication abuse - Prevention Pharmaceutical policy |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Curbing prescription drug abuse in Medicare |
| Record Nr. | UNINA-9910705315603321 |
| Washington : , : U.S. Government Printing Office, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drug compounding, FDA has taken steps to implement compounding law, but some states and stakeholders reported challenges : report to Congressional Committees
| Drug compounding, FDA has taken steps to implement compounding law, but some states and stakeholders reported challenges : report to Congressional Committees |
| Pubbl/distr/stampa | [Washington, D.C.] : , : United States Government Accountability Office, , 2016 |
| Descrizione fisica | 1 online resource (iii, 65 pages) : color illustrations |
| Soggetto topico |
Drugs - Dosage forms
Pharmaceutical policy Drug control Drugs - Law and legislation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Drug compounding, FDA has taken steps to implement compounding law, but some states and stakeholders reported challenges |
| Record Nr. | UNINA-9910707890003321 |
| [Washington, D.C.] : , : United States Government Accountability Office, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drug importation : would the price be right? : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining the price of drug reimportation, focusing on implications for United States consumers, pricing, research and development, and innovation, February 17, 2005
| Drug importation : would the price be right? : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining the price of drug reimportation, focusing on implications for United States consumers, pricing, research and development, and innovation, February 17, 2005 |
| Descrizione fisica | 1 online resource (iii, 105 p.) : ill |
| Soggetto topico |
Drug reimportation - United States
Prescription pricing - United States Drugs - Purchasing - United States Pharmaceutical policy - United States Foreign trade regulation - United States Drug reimportation Drugs - Purchasing Foreign trade regulation Pharmaceutical policy Prescription pricing |
| Soggetto non controllato |
Pricing
Drugs Pharmaceutical policy Foreign trade regulation Business & economics Medical Political science Law |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Drug Importation |
| Record Nr. | UNINA-9910694099103321 |
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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