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Guidance for industry [[electronic resource] ] : M4S, the CTD, safety
| Guidance for industry [[electronic resource] ] : M4S, the CTD, safety |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2001] |
| Descrizione fisica | ii, 21 pages : digital, PDF file |
| Soggetto topico |
Drug approval - Government policy - United States
Clinical trials - Reporting - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698948603321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : M4S, the CTD, safety appendices
| Guidance for industry [[electronic resource] ] : M4S, the CTD, safety appendices |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2001] |
| Descrizione fisica | pages 21-115 : digital, PDF file |
| Soggetto topico |
Drug approval - Government policy - United States
Clinical trials - Reporting - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698948403321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : M4Q, the CTD, quality
| Guidance for industry [[electronic resource] ] : M4Q, the CTD, quality |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2001] |
| Descrizione fisica | 29 pages : digital, PDF file |
| Soggetto topico |
Drugs - Quality control - Government policy - United States
Drug approval - Government policy - United States Clinical trials - Reporting - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698948703321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2001] | ||
| 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 | ||
| ||
Reviewer guidance [[electronic resource] ] : conducting a clinical safety review of a new product application and preparing a report on the review
| Reviewer guidance [[electronic resource] ] : conducting a clinical safety review of a new product application and preparing a report on the review |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2005] |
| Descrizione fisica | 1 online resource (79 pages) |
| Soggetto topico |
Clinical trials - Reporting - Government policy - United States
Drug approval - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Reviewer guidance |
| Record Nr. | UNINA-9910699113103321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Structure and content of clinical study reports [[electronic resource]]
| Structure and content of clinical study reports [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, Md] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], , [1996] |
| Descrizione fisica | 1 online resource (various pagings) : forms, charts |
| Collana | Guideline for industry |
| Soggetto topico | Clinical trials - Reporting - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910699264003321 |
| [Rockville, Md] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], , [1996] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Soggetto topico
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Clinical trials - Reporting - Government policy - United States
(6)
- Drug approval - Government policy - United States (4)
- Drugs - Quality control - Government policy - United States (1)
- Institutional review boards (Medicine) - Government policy - United States (1)
- Medical research personnel - Government policy - United States (1)