Info
- Utilizzare la checkbox di selezione a fianco di ciascun documento per attivare le funzionalità di stampa, invio email, download nei formati disponibili del (i) record.
Addendum to ICH S6 [[electronic resource] ] : preclinical safety evaluation of biotechnology-derived pharmaceuticals
| Addendum to ICH S6 [[electronic resource] ] : preclinical safety evaluation of biotechnology-derived pharmaceuticals |
| Pubbl/distr/stampa | [Rockville, Md.?] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [2009] |
| Descrizione fisica | 1 online resource (iv, 14 pages) |
| Soggetto topico |
Pharmaceutical biotechnology
Drugs - Testing |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Addendum to ICH S6 |
| Record Nr. | UNINA-9910699222303321 |
| [Rockville, Md.?] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Data elements and standards for drug dictionaries, M5 [[electronic resource]]
| Data elements and standards for drug dictionaries, M5 [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, MD?] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [2005] |
| Descrizione fisica | 31 pages : digital, PDF file |
| Soggetto topico | Drugs |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910698957603321 |
| [Rockville, MD?] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Detection of toxicity to reproduction for medicinal products [[electronic resource]]
| Detection of toxicity to reproduction for medicinal products [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1994] |
| Descrizione fisica | 1 online resource (iii, 17, 2, 11 pages) |
| Collana | Guideline for industry |
| Soggetto topico |
Fertility - Effect of drugs on
Drugs - Toxicology |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910699222603321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1994] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (a guide to informed consent)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (a guide to informed consent) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Informed consent (Medical law) - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698912503321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (charging for investigational products)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (charging for investigational products) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698919003321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (cooperative research)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (cooperative research) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Institutional review boards (Medicine) - Government policy - United States
Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698926203321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (use of investigational products when subjects enter a second institution)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (use of investigational products when subjects enter a second institution) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698911803321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (frequently asked questions)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (frequently asked questions) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Institutional review boards (Medicine) - Government policy - United States
Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698926303321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (acceptance of foreign clinical studies)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators (acceptance of foreign clinical studies) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Clinical trials - Reporting - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698919203321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators ("off-label" and investigational use of marketed drugs, biologics, and medical devices)
| Information sheet [[electronic resource] ] : guidance for institutional review boards and clinical investigators ("off-label" and investigational use of marketed drugs, biologics, and medical devices) |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Medicine, Experimental - Government policy - United States
Institutional review boards (Medicine) - Government policy - United States Medical research personnel - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Information sheet |
| Record Nr. | UNINA-9910698911403321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration], , [1998?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
