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 | ||
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Lo trovi qui: Univ. Federico II | ||
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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 |
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 | ||
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Lo trovi qui: Univ. Federico II | ||
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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 |
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-9910828713903321 |
Washington, D.C., : National Academies Press, c2009 | ||
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Lo trovi qui: Univ. Federico II | ||
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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
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[Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2011] | ||
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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 |
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
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[Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2008] | ||
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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 |
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
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[Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2007] | ||
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Lo trovi qui: Univ. Federico II | ||
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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
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[Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2007] | ||
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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 |
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] | ||
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Lo trovi qui: Univ. Federico II | ||
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Integrated cardiac safety [[electronic resource] ] : 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 |
1-282-00206-6
9786612002069 0-470-41129-5 0-470-41128-7 |
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 |
Turner J. Rick
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Hoboken, N.J., : John Wiley & Sons, c2009 | ||
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Lo trovi qui: Univ. Federico II | ||
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Las medicinas en la vejez [[electronic resource]] |
Pubbl/distr/stampa | Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, , [2000] |
Descrizione fisica | 12 pages : digital, PDF file |
Collana | (FDA) |
Soggetto topico |
Older people - Drug use - United States
Drugs - Overdose Drugs - Safety measures |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | spa |
Record Nr. | UNINA-9910695326403321 |
Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, , [2000] | ||
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Lo trovi qui: Univ. Federico II | ||
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