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Accelerating the development of biomarkers for drug safety [[electronic resource] ] : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Accelerating the development of biomarkers for drug safety [[electronic resource] ] : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2009 |
| Descrizione fisica | 1 online resource (99 p.) |
| Disciplina | 616.075 |
| Altri autori (Persone) |
GiffinRobert B
OlsonSteve <1956-> RobinsonSally |
| Soggetto topico |
Biochemical markers
Drugs - Safety measures Drugs - Testing |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-282-27265-9
9786612272653 0-309-13125-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910454905103321 |
| Washington, D.C., : National Academies Press, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Accelerating the development of biomarkers for drug safety [[electronic resource] ] : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Accelerating the development of biomarkers for drug safety [[electronic resource] ] : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2009 |
| Descrizione fisica | 1 online resource (99 p.) |
| Disciplina | 616.075 |
| Altri autori (Persone) |
GiffinRobert B
OlsonSteve <1956-> RobinsonSally |
| Soggetto topico |
Biochemical markers
Drugs - Safety measures Drugs - Testing |
| ISBN |
0-309-14231-8
1-282-27265-9 9786612272653 0-309-13125-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Overview Of key issues -- Cardiac safety biomarkers -- Assessing and predicting kidney safety -- Biomarkers of acute idiosyncratic hepatocellular injury in clinical trials -- Future considerations. |
| Record Nr. | UNINA-9910778330203321 |
| Washington, D.C., : National Academies Press, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Accelerating the development of biomarkers for drug safety : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Accelerating the development of biomarkers for drug safety : workshop summary / / Steve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2009 |
| Descrizione fisica | 1 online resource (99 p.) |
| Disciplina | 616.075 |
| Altri autori (Persone) |
GiffinRobert B
OlsonSteve <1956-> RobinsonSally |
| Soggetto topico |
Biochemical markers
Drugs - Safety measures Drugs - Testing |
| ISBN |
0-309-14231-8
1-282-27265-9 9786612272653 0-309-13125-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Overview Of key issues -- Cardiac safety biomarkers -- Assessing and predicting kidney safety -- Biomarkers of acute idiosyncratic hepatocellular injury in clinical trials -- Future considerations. |
| Record Nr. | UNINA-9910974537203321 |
| Washington, D.C., : National Academies Press, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug safety [[electronic resource] ] : FDA faces challenges overseeing the foreign drug manufacturing supply chain : testimony before the Committee on Health, Education, Labor, and Pensions, U.S. Senate / / statement of Marcia Crosse
| Drug safety [[electronic resource] ] : FDA faces challenges overseeing the foreign drug manufacturing supply chain : testimony before the Committee on Health, Education, Labor, and Pensions, U.S. Senate / / statement of Marcia Crosse |
| Autore | Crosse Marcia |
| Pubbl/distr/stampa | [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2011] |
| Descrizione fisica | 1 online resource (15 pages) |
| Collana | Testimony |
| Soggetto topico |
Drugs - Safety measures
Drugs - Safety measures - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Drug safety |
| Record Nr. | UNINA-9910701237703321 |
Crosse Marcia
|
||
| [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2011] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drug safety [[electronic resource] ] : preliminary findings suggest recent FDA initiatives have potential, but do not fully address weaknesses in its foreign drug inspection program : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives / / statement of Marcia Crosse
| Drug safety [[electronic resource] ] : preliminary findings suggest recent FDA initiatives have potential, but do not fully address weaknesses in its foreign drug inspection program : testimony before the Subcommittee on Oversight and Investigations, 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, , [2008] |
| Descrizione fisica | 19 pages : digital, PDF file |
| Collana | Testimony |
| Soggetto topico |
Drugs - Safety measures
Drugs - Inspection |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Drug safety |
| Record Nr. | UNINA-9910696615703321 |
|
Crosse Marcia
|
||
| [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drug safety [[electronic resource] ] : preliminary findings suggest weaknesses in FDA's program for inspecting foreign drug manufacturers : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives / / statement of Marcia Crosse
| Drug safety [[electronic resource] ] : preliminary findings suggest weaknesses in FDA's program for inspecting foreign drug manufacturers : testimony before the Subcommittee on Oversight and Investigations, 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 | 24 pages : digital, PDF file |
| Collana | Testimony |
| Soggetto topico |
Drugs - Safety measures
Drugs - Inspection |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Drug safety |
| Record Nr. | UNINA-9910696397103321 |
|
Crosse Marcia
|
||
| [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug safety [[electronic resource] ] : further actions needed to improve FDA's postmarket decision-making process : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives / / statement of Marcia Crosse
| Drug safety [[electronic resource] ] : further actions needed to improve FDA's postmarket decision-making process : 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 | 13 pages : digital, PDF file |
| Collana | Testimony |
| Soggetto topico |
Drugs - Safety measures
Drugs - Safety measures - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Drug safety |
| Record Nr. | UNINA-9910695979303321 |
|
Crosse Marcia
|
||
| [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drug safety [[electronic resource] ] : better data management and more inspections are needed to strengthen FDA's foreign drug inspection program : report to congressional requesters
| Drug safety [[electronic resource] ] : better data management and more inspections are needed to strengthen FDA's foreign drug inspection program : report to congressional requesters |
| Pubbl/distr/stampa | [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2008] |
| Descrizione fisica | ii, 53 pages : digital, PDF file |
| Soggetto topico |
Drugs - Safety measures
Pharmaceutical industry - Foreign countries |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Drug safety |
| Record Nr. | UNINA-9910697853703321 |
| [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Expert opinion on drug safety
| Expert opinion on drug safety |
| Pubbl/distr/stampa | London, : Ashley Publications, 2002- |
| Soggetto topico |
Drugs - Toxicology
Drugs - Side effects Drugs - Safety measures Consumer Product Safety Drug-Related Side Effects and Adverse Reactions Product Surveillance, Postmarketing Pharmaceutical Preparations Drug Evaluation Drug Therapy - adverse effects Médicaments - Effets secondaires Médicaments - Toxicologie Chimiothérapie Médicaments Pharmacovigilance |
| Soggetto genere / forma |
Periodical
Periodicals. |
| ISSN | 1744-764X |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910985991203321 |
| London, : Ashley Publications, 2002- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Integrated cardiac safety : assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance / / J. Rick Turner, Todd A. Durham
| Integrated cardiac safety : assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance / / J. Rick Turner, Todd A. Durham |
| Autore | Turner J. Rick |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2009 |
| Descrizione fisica | 1 online resource (500 p.) |
| Disciplina | 616.1/23061 |
| Altri autori (Persone) | DurhamTodd A |
| Soggetto topico |
Cardiovascular toxicology
Heart - Effect of drugs on Drugs - Side effects - Testing Drugs - Safety measures |
| ISBN |
9786612002069
9781282002067 1282002066 9780470411292 0470411295 9780470411285 0470411287 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | The importance of cardiac safety assessments -- The biological basis of adverse drug reactions -- Cardiac structure and function -- Cardiac pathophysiology and disease -- Drug discovery and drug design -- Nonclinical development -- The thorough QT/QTc trial -- General safety assessments -- Therapeutic use trials and meta-analyses -- Assessment methodologies in nonexperimental postmarketing surveillance -- Postmarketing proarrhythmic cardiac safety assessments -- Generalized cardiac safety -- Medication errors, adherence, and concordance -- Future directions in drug safety. |
| Record Nr. | UNINA-9910144409203321 |
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Turner J. Rick
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| Hoboken, N.J., : John Wiley & Sons, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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