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Refining processes for the co-development of genome-based therapeutics and companion diagnostic tests : workshop summary / / Sarah H. Beachy [and three others], Rapporteurs Roundtable on Translating Genomic-Based Research for Health Board on Health Sciences Policy
| Refining processes for the co-development of genome-based therapeutics and companion diagnostic tests : workshop summary / / Sarah H. Beachy [and three others], Rapporteurs Roundtable on Translating Genomic-Based Research for Health Board on Health Sciences Policy |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , 2014 |
| Descrizione fisica | 1 online resource (102 p.) |
| Disciplina | 615.19 |
| Soggetto topico |
Drug development - United States
Gene therapy - United States Therapeutics - United States |
| ISBN |
0-309-29824-5
0-309-29822-9 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Acknowledgments""; ""Contents""; ""Boxes, Figures, and Tables""; ""Abbreviations and Acronyms""; ""1 Introduction""; ""2 Regulatory Perspectives""; ""3 Perspectives from Patients, Providers, and Laboratory Representatives""; ""4 Perspectives of Diagnostic Test and Pharmaceutical Developers""; ""5 Perspectives of Payers and Regulators""; ""6 Concluding Observations""; ""References""; ""Appendix A: Workshop Agenda""; ""Appendix B: Speaker Biographical Sketches""; ""Appendix C: Statement of Task""; ""Appendix D: Registered Attendees"" |
| Record Nr. | UNINA-9910789360503321 |
| Washington, District of Columbia : , : National Academies Press, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Refining processes for the co-development of genome-based therapeutics and companion diagnostic tests : workshop summary / / Sarah H. Beachy [and three others], Rapporteurs Roundtable on Translating Genomic-Based Research for Health Board on Health Sciences Policy
| Refining processes for the co-development of genome-based therapeutics and companion diagnostic tests : workshop summary / / Sarah H. Beachy [and three others], Rapporteurs Roundtable on Translating Genomic-Based Research for Health Board on Health Sciences Policy |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , 2014 |
| Descrizione fisica | 1 online resource (102 p.) |
| Disciplina | 615.19 |
| Soggetto topico |
Drug development - United States
Gene therapy - United States Therapeutics - United States |
| ISBN |
0-309-29824-5
0-309-29822-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Acknowledgments""; ""Contents""; ""Boxes, Figures, and Tables""; ""Abbreviations and Acronyms""; ""1 Introduction""; ""2 Regulatory Perspectives""; ""3 Perspectives from Patients, Providers, and Laboratory Representatives""; ""4 Perspectives of Diagnostic Test and Pharmaceutical Developers""; ""5 Perspectives of Payers and Regulators""; ""6 Concluding Observations""; ""References""; ""Appendix A: Workshop Agenda""; ""Appendix B: Speaker Biographical Sketches""; ""Appendix C: Statement of Task""; ""Appendix D: Registered Attendees"" |
| Record Nr. | UNINA-9910813019103321 |
| Washington, District of Columbia : , : National Academies Press, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Strengthening a workforce for innovative regulatory science in therapeutics development [[electronic resource] ] : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy
| Strengthening a workforce for innovative regulatory science in therapeutics development [[electronic resource] ] : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, 2012 |
| Descrizione fisica | 1 online resource (119 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
OlsenSteve
ClaiborneAnne B |
| Soggetto topico | Drug development - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-38019-5
9786613558107 0-309-22215-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""1 Introduction""; ""2 The Importance of Innovative Regulatory Science""; ""3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce""; ""4 Education and Training of a Regulatory Science Workforce""; ""5 Career Paths Within Academia and Industry""; ""6 International Applications of Regulatory Science""; ""7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice""; ""References""; ""Appendix A: Workshop Agenda""
""Appendix B: Participant Biographies"" |
| Record Nr. | UNINA-9910451856403321 |
| Washington, D.C., : National Academies Press, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Strengthening a workforce for innovative regulatory science in therapeutics development [[electronic resource] ] : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy
| Strengthening a workforce for innovative regulatory science in therapeutics development [[electronic resource] ] : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, 2012 |
| Descrizione fisica | 1 online resource (119 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
OlsenSteve
ClaiborneAnne B |
| Soggetto topico | Drug development - United States |
| ISBN |
0-309-22217-6
1-280-38019-5 9786613558107 0-309-22215-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""1 Introduction""; ""2 The Importance of Innovative Regulatory Science""; ""3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce""; ""4 Education and Training of a Regulatory Science Workforce""; ""5 Career Paths Within Academia and Industry""; ""6 International Applications of Regulatory Science""; ""7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice""; ""References""; ""Appendix A: Workshop Agenda""
""Appendix B: Participant Biographies"" |
| Record Nr. | UNINA-9910779292703321 |
| Washington, D.C., : National Academies Press, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Strengthening a workforce for innovative regulatory science in therapeutics development : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy
| Strengthening a workforce for innovative regulatory science in therapeutics development : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, 2012 |
| Descrizione fisica | 1 online resource (119 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
OlsenSteve
ClaiborneAnne B |
| Soggetto topico | Drug development - United States |
| ISBN |
0-309-22217-6
1-280-38019-5 9786613558107 0-309-22215-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""1 Introduction""; ""2 The Importance of Innovative Regulatory Science""; ""3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce""; ""4 Education and Training of a Regulatory Science Workforce""; ""5 Career Paths Within Academia and Industry""; ""6 International Applications of Regulatory Science""; ""7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice""; ""References""; ""Appendix A: Workshop Agenda""
""Appendix B: Participant Biographies"" |
| Record Nr. | UNINA-9910813819603321 |
| Washington, D.C., : National Academies Press, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Strengthening Public Health Emergency Response Act of 2016 : report together with dissenting views (to accompany H.R. 3299) (including cost estimate of the Congressional Budget Office)
| Strengthening Public Health Emergency Response Act of 2016 : report together with dissenting views (to accompany H.R. 3299) (including cost estimate of the Congressional Budget Office) |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2016] |
| Descrizione fisica | 1 online resource (54 pages) |
| Collana | Report / 114th Congress, 2d session, House of Representatives |
| Soggetto topico |
Biosecurity - United States
Emergency management - Law and legislation - United States Drug development - United States Public health laws - United States |
| Soggetto genere / forma | Legislative materials. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Strengthening Public Health Emergency Response Act of 2016 |
| Record Nr. | UNINA-9910707689203321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2016] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
SUPAC-IR questions and answers about SUPAC-IR guidance [[electronic resource]]
| SUPAC-IR questions and answers about SUPAC-IR guidance [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, Md.] : , : Food and Drug Administration, , [1997] |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Solid dosage forms - United States
Drug development - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Scale-up, post-approval changes, immediate release |
| Record Nr. | UNINA-9910697093603321 |
| [Rockville, Md.] : , : Food and Drug Administration, , [1997] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Unsustainable drug prices : hearing before the Committee on Oversight and Reform, House of Representatives
| Unsustainable drug prices : hearing before the Committee on Oversight and Reform, House of Representatives |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2020-2021 |
| Descrizione fisica | 1 online resource (3 volumes) |
| Disciplina | 4.OV 2:116-123 |
| Soggetto topico |
Prescription pricing - United States
Drugs - Prices - United States Pharmaceutical industry - United States - Costs Pharmaceutical policy - United States Drug development - United States Drug development Drugs - Prices Pharmaceutical industry - Costs Pharmaceutical policy Prescription pricing |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Unsustainable drug prices |
| Record Nr. | UNINA-9910715175203321 |
| Washington : , : U.S. Government Publishing Office, , 2020-2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
