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Discussion drafts concerning Prescription Drug User Fee Act reauthorization, Medical Device User Fee and Modernization Act reauthorization, drug safety, and certain pediatric pharmaceutical and device legislation [[electronic resource] ] : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, June 12, 2007
| Discussion drafts concerning Prescription Drug User Fee Act reauthorization, Medical Device User Fee and Modernization Act reauthorization, drug safety, and certain pediatric pharmaceutical and device legislation [[electronic resource] ] : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, June 12, 2007 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2008 |
| Descrizione fisica | vi, 311 pages : digital, PDF file |
| Soggetto topico |
Prescription pricing - Law and legislation - United States
Medical instruments and apparatus industry - Law and legislation - United States Pediatric pharmacology - United States Drugs - Safety measures - Government policy - United States User charges - Law and legislation - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Discussion drafts concerning Prescription Drug User Fee Act reauthorization, Medical Device User Fee and Modernization Act reauthorization, drug safety, and certain pediatric pharmaceutical and device legislation |
| Record Nr. | UNINA-9910697826103321 |
| Washington : , : U.S. G.P.O., , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Ensuring safe medicines and medical devices for children [[electronic resource] ] : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007
| Ensuring safe medicines and medical devices for children [[electronic resource] ] : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2008 |
| Descrizione fisica | iii, 60 pages : digital, PDF file |
| Collana | S. hrg. |
| Soggetto topico |
Children - Diseases - Treatment - United States - Safety measures
Children - Diseases - Treatment - Technological innovations - United States - Safety measures Pediatric pharmacology - United States Pediatrics - Research - United States Medical instruments and apparatus - Safety regulations - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Ensuring safe medicines and medical devices for children |
| Record Nr. | UNINA-9910697989103321 |
| Washington : , : U.S. G.P.O., , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Evaluating the effectiveness of the Food And Drug Administration Modernization Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, first session, May 3, 2001
| Evaluating the effectiveness of the Food And Drug Administration Modernization Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, first session, May 3, 2001 |
| Descrizione fisica | 1 online resource (iii, 166 p.) |
| Soggetto topico |
Pharmaceutical policy - United States
Drugs - United States - Testing Pediatric pharmacology - United States |
| Soggetto non controllato |
United States
Pharmaceutical policy Drugs Pediatric pharmacology Political science Medical |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Evaluating the effectiveness of the Food And Drug Administration Modernization Act |
| Record Nr. | UNINA-9910689420003321 |
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Johnson & Johnson's recall of Children's Tylenol and other children's medicines [[electronic resource] ] : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Eleventh Congress, second session
| Johnson & Johnson's recall of Children's Tylenol and other children's medicines [[electronic resource] ] : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Eleventh Congress, second session |
| Pubbl/distr/stampa | Washington, : U.S. G.P.O., 2011- |
| Descrizione fisica | 1 online resource (v.) : illustrations |
| Soggetto topico |
Product recall - United States
Drugs, Nonprescription - United States Pediatric pharmacology - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Johnson & Johnson's recall of Children's Tylenol and other children's medicines |
| Record Nr. | UNINA-9910703143203321 |
| Washington, : U.S. G.P.O., 2011- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pediatric drug research [[electronic resource] ] : the study and labeling of drugs for pediatric use under the Best Pharmaceuticals for Children Act : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives / / statement of Marcia Crosse
| Pediatric drug research [[electronic resource] ] : the study and labeling of drugs for pediatric use under the Best Pharmaceuticals for Children Act : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives / / statement of Marcia Crosse |
| Autore | Crosse Marcia |
| Pubbl/distr/stampa | [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2007] |
| Descrizione fisica | 14 pages : digital, PDF file |
| Collana | Testimony |
| Soggetto topico |
Pediatric pharmacology - United States
Drugs - Research - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Pediatric drug research |
| Record Nr. | UNINA-9910695984403321 |
Crosse Marcia
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| [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2007] | ||
| 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 |
9786613620255
9781280590429 1280590424 9781118168257 1118168259 9781118168226 1118168224 9781118168264 1118168267 |
| 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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Programs affecting safety and innovation in pediatric therapies [[electronic resource] ] : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 22, 2007
| Programs affecting safety and innovation in pediatric therapies [[electronic resource] ] : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 22, 2007 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2008 |
| Descrizione fisica | v, 153 pages : digital, PDF file |
| Soggetto topico |
Children - Diseases - Treatment - United States - Safety measures
Children - Diseases - Treatment - Technological innovations - United States - Safety measures Pediatric pharmacology - United States Pediatrics - Research - United States Medical instruments and apparatus - Safety regulations - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Programs affecting safety and innovation in pediatric therapies |
| Record Nr. | UNINA-9910697868003321 |
| Washington : , : U.S. G.P.O., , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Safety efforts in pediatric drug development [[electronic resource] /] / Conor D. Byrne, editor
| Safety efforts in pediatric drug development [[electronic resource] /] / Conor D. Byrne, editor |
| Pubbl/distr/stampa | New York, : Nova Science Publishers, c2010 |
| Descrizione fisica | 1 online resource (149 p.) |
| Disciplina | 615/.190083 |
| Altri autori (Persone) | ByrneConor D |
| Collana | Pharmacology--research, safety testing and regulation series |
| Soggetto topico |
Pediatric pharmacology - United States
Pediatrics - United States - Formulae, receipts, prescriptions - Safety measures Drug development - United States - Safety measures |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-61209-368-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910465691903321 |
| New York, : Nova Science Publishers, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Safety efforts in pediatric drug development [[electronic resource] /] / Conor D. Byrne, editor
| Safety efforts in pediatric drug development [[electronic resource] /] / Conor D. Byrne, editor |
| Pubbl/distr/stampa | New York, : Nova Science Publishers, c2010 |
| Descrizione fisica | 1 online resource (149 p.) |
| Disciplina | 615/.190083 |
| Altri autori (Persone) | ByrneConor D |
| Collana | Pharmacology--research, safety testing and regulation series |
| Soggetto topico |
Pediatric pharmacology - United States
Pediatrics - United States - Formulae, receipts, prescriptions - Safety measures Drug development - United States - Safety measures |
| ISBN | 1-61209-368-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | FDA's authority to ensure that drugs prescribed to children are safe and effective / Susan Thaul -- Guidance for industry nonclinical safety evaluation of pediatric drug products / U.S. Dept. of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER) -- Pediatric drug research : studies conducted under Best Pharmaceuticals for Children Act / GAO -- Pediatric drug research : the study and labeling of drugs for pediatric use under the Best Pharmaceuticals for Children Act / GAO. |
| Record Nr. | UNINA-9910791770003321 |
| New York, : Nova Science Publishers, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Soggetto topico
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Pediatric pharmacology - United States
(9)
- Pediatrics - United States - Formulae, receipts, prescriptions - Safety measures (3)
- Children - Diseases - Treatment - Technological innovations - United States - Safety measures (2)
- Children - Diseases - Treatment - United States - Safety measures (2)
- Drug development - United States - Safety measures (2)