Clinical safety data management [[electronic resource] ] : definitions and standards for expedited reporting |
Pubbl/distr/stampa | [Rockville, Md.] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [1995] |
Descrizione fisica | 1 online resource (ii, 11, 3 pages) |
Collana | Guideline for industry |
Soggetto topico |
Drugs - Dosage - United States
Drugs - Side effects - Reporting - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Clinical safety data management |
Record Nr. | UNINA-9910699267803321 |
[Rockville, Md.] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [1995] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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The extent of population exposure to assess clinical safety [[electronic resource] ] : for drugs intended for long-term treatment of of non-life threatening conditions |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [1995] |
Descrizione fisica | 1 online resource (4 pages) |
Collana | Guideline for industry |
Soggetto topico |
Drugs - Dosage - United States
Drugs - Side effects - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Extent of population exposure to assess clinical safety |
Record Nr. | UNINA-9910699268403321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [1995] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : dosage delivery devices for OTC liquid drug products |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2009] |
Descrizione fisica | 1 online resource (10 pages) : illustrations |
Soggetto topico |
Drugs - Dosage - United States
Drug delivery systems - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910703824503321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2009] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Guidance for industry [[electronic resource] ] : single dose acute toxicity testing for pharmaceuticals |
Pubbl/distr/stampa | [Rockville, MD] : , : Center for Drug Evaluation and Research, , [1996] |
Descrizione fisica | 1 electronic resource (2 pages) |
Soggetto topico |
Drugs - Dosage - United States
Acute toxicity testing - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910696957203321 |
[Rockville, MD] : , : Center for Drug Evaluation and Research, , [1996] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Guidance for industry - dosage delivery devices for OTC liquid drug products |
Pubbl/distr/stampa | [Rockville, Md.] : , : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , 2011 |
Descrizione fisica | 1 online resource (11 pages) : illustrations |
Soggetto topico |
Drugs - Dosage - United States
Drug delivery systems - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti |
Guidance for industry - dosage delivery devices for over the counter liquid drug products
Dosage delivery devices for OTC liquid drug products |
Record Nr. | UNINA-9910703824103321 |
[Rockville, Md.] : , : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , 2011 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Memorandum report : renal dialysis facilities' dosage protocols for administering erythropoiesis-stimulating agents |
Pubbl/distr/stampa | Washington, D.C. : , : Department of Health & Human Services, Office of Inspector General, , 2009 |
Descrizione fisica | 1 online resource (15 pages) : illustrations |
Soggetto topico |
Medicare
Erythropoiesis Hemodialysis - United States Chronic renal failure - Treatment - United States Drugs - Dosage - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Memorandum report |
Record Nr. | UNINA-9910707366003321 |
Washington, D.C. : , : Department of Health & Human Services, Office of Inspector General, , 2009 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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