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Guidance for industry and review staff [[electronic resource] ] : recommended approaches to integration of genetic toxicology study results
| Guidance for industry and review staff [[electronic resource] ] : recommended approaches to integration of genetic toxicology study results |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] |
| Descrizione fisica | 1 online resource (5 pages) |
| Soggetto topico |
Genetic toxicology - United States
Drug development - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and review staff |
| Record Nr. | UNINA-9910696958303321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Legislative hearing on 21st century cures : hearing before the Subcommittee on Energy and Commerce, House of Representatives, One Hundred Fourteenth Congress, first session, April 30, 2015
| Legislative hearing on 21st century cures : hearing before the Subcommittee on Energy and Commerce, House of Representatives, One Hundred Fourteenth Congress, first session, April 30, 2015 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2016 |
| Descrizione fisica | 1 online resource (iv, 128 pages) |
| Soggetto topico |
Medical innovations - Law and legislation - United States
Drug development - United States Clinical trials - Law and legislation - United States Medical instruments and apparatus - Testing - Law and legislation - United States Clinical trials - Law and legislation Drug development Medical innovations - Law and legislation Medical instruments and apparatus - Testing - Law and legislation |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Legislative hearing on 21st century cures |
| Record Nr. | UNINA-9910707168503321 |
| Washington : , : U.S. Government Publishing Office, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Maximizing the impact of the Cures Acceleration Network : accelerating the development of new drugs and diagnostics : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Maximizing the impact of the Cures Acceleration Network : accelerating the development of new drugs and diagnostics : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , [2012] |
| Descrizione fisica | 1 online resource (132 p.) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug monitoring
Drug development - United States Drugs - United States - Design Pharmaceutical industry - United States - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN | 0-309-26117-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction [The history and goals of CAN (Cures Acceleration Network)] -- Approaches to accelerating translational science -- Application of matching authority -- Application of flexible research authority -- Situating CAN within the drug development ecosystem -- Final reflections on ways to maximize the goals of CAN. |
| Record Nr. | UNINA-9910463950903321 |
| Washington, District of Columbia : , : National Academies Press, , [2012] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Maximizing the impact of the Cures Acceleration Network : accelerating the development of new drugs and diagnostics : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Maximizing the impact of the Cures Acceleration Network : accelerating the development of new drugs and diagnostics : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , [2012] |
| Descrizione fisica | 1 online resource (132 p.) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug monitoring
Drug development - United States Drugs - United States - Design Pharmaceutical industry - United States - Quality control |
| ISBN |
0-309-26119-8
0-309-26117-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction [The history and goals of CAN (Cures Acceleration Network)] -- Approaches to accelerating translational science -- Application of matching authority -- Application of flexible research authority -- Situating CAN within the drug development ecosystem -- Final reflections on ways to maximize the goals of CAN. |
| Record Nr. | UNINA-9910787308103321 |
| Washington, District of Columbia : , : National Academies Press, , [2012] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Maximizing the impact of the Cures Acceleration Network : accelerating the development of new drugs and diagnostics : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Maximizing the impact of the Cures Acceleration Network : accelerating the development of new drugs and diagnostics : workshop summary / / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , [2012] |
| Descrizione fisica | 1 online resource (132 p.) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug monitoring
Drug development - United States Drugs - United States - Design Pharmaceutical industry - United States - Quality control |
| ISBN |
0-309-26119-8
0-309-26117-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction [The history and goals of CAN (Cures Acceleration Network)] -- Approaches to accelerating translational science -- Application of matching authority -- Application of flexible research authority -- Situating CAN within the drug development ecosystem -- Final reflections on ways to maximize the goals of CAN. |
| Record Nr. | UNINA-9910826891403321 |
| Washington, District of Columbia : , : National Academies Press, , [2012] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 : report (to accompany H.R. 4369)
| National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 : report (to accompany H.R. 4369) |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2021] |
| Descrizione fisica | 1 online resource (16 pages) |
| Collana | Report / 117th Congress, 1st session, House of Representatives |
| Soggetto topico |
Pharmaceutical technology - United States
Drug development - United States Medical innovations - Law and legislation - United States |
| Soggetto genere / forma | Legislative materials. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 |
| Record Nr. | UNINA-9910716998003321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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New drug development [[electronic resource] ] : science, business, regulatory, and intellectual property issues cited as hampering drug development efforts : report to congressional requesters
| New drug development [[electronic resource] ] : science, business, regulatory, and intellectual property issues cited as hampering drug development efforts : report to congressional requesters |
| Pubbl/distr/stampa | [Washington, D.C.] : , : U.S. Government Accountability Office, , [2006] |
| Descrizione fisica | ii, 47 pages : digital, PDF file |
| Soggetto topico |
Pharmaceutical industry - Research - United States
Drug development - United States Drug approval - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | New drug development |
| Record Nr. | UNINA-9910695592703321 |
| [Washington, D.C.] : , : U.S. Government Accountability Office, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pediatric non-clinical drug testing : principles, requirements, and practice / / edited by Alan M. Hoberman, Elise M. Lewis
| Pediatric non-clinical drug testing : principles, requirements, and practice / / edited by Alan M. Hoberman, Elise M. Lewis |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, 2012 |
| Descrizione fisica | 1 online resource (370 p.) |
| Disciplina | 615.7/040287 |
| Altri autori (Persone) |
HobermanAlan M
LewisElise M |
| Soggetto topico |
Drug development - United States
Pediatric pharmacology - United States Pediatrics - United States - Formulae, receipts, prescriptions - Safety measures |
| ISBN |
1-280-59042-4
9786613620255 1-118-16825-9 1-118-16822-4 1-118-16826-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Machine generated contents note: Introduction and the history of pediatric nonclinical drug testing / Elise M. Lewis, Luc M. deSchepdrijver, Timothy P. Coogan -- Overview of pediatric diseases and clinical considerations on developing medicines for children / Bert Suys, Jose Ramet -- Nonclinical safety assessment for biopharmaceuticals : challenges and strategies for juvenile animal testing / Timothy P. Coogan -- FDA approach to pediatric testing / Robert E. Osterberg -- Pediatric drug development plans / Kimberly Brennan, Beatriz Silva Lima -- Application of principles of nonclinical pediatric drug testing to the hazard evaluation of environmental contaminants / Susan L. Makris -- Nonclinical testing procedures - pharmacokinetics / Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert -- Preclinical development of a pharmaceutical product for children / Graham P. Bailey, Timothy P. Coogan, Luc M. De Schaepdrijver -- Juvenile toxicity study design for the rodent and rabbit / Alan M. Hoberman, and John Barnett Jr. -- Dog juvenile toxicity / Keith Robinson, Susan Y. Smith, and Andre Viau -- Use of the swine pediatric model / Paul C. Barrow -- Juvenile immuno-development in minipigs / Andre H Penninks ... [et al.] -- Use of primate pediatric model / Gerhard F. Weinbauer -- Approaches to rat juvenile toxicity studies and case studies : a pharmaceutical perspective / Susan B. Laffan, and Lorraine Posobiec. |
| Record Nr. | UNINA-9910139706303321 |
| Hoboken, N.J., : John Wiley & Sons, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pharmaceutical development phases [[electronic resource] ] : a duration analysis / / Rosa M. Abrantes-Metz, Christopher P. Adams, Albert Metz
| Pharmaceutical development phases [[electronic resource] ] : a duration analysis / / Rosa M. Abrantes-Metz, Christopher P. Adams, Albert Metz |
| Autore | Abrantes-Metz Rosa M |
| Pubbl/distr/stampa | Washington, DC : , : Bureau of Economics, Federal Trade Commission, , [2004] |
| Descrizione fisica | 29 pages : digital, PDF file |
| Altri autori (Persone) |
AdamsChristopher P
MetzAlbert |
| Collana | Working paper |
| Soggetto topico |
Drug development - United States
Pharmaceutical industry - United States - Quality control |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Pharmaceutical development phases |
| Record Nr. | UNINA-9910696622903321 |
Abrantes-Metz Rosa M
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| Washington, DC : , : Bureau of Economics, Federal Trade Commission, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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 |
| Soggetto genere / forma | Electronic books. |
| ISBN | 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-9910464441603321 |
| Washington, District of Columbia : , : National Academies Press, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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