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Guidance for clinical investigators, sponsors, and IRBs [[electronic resource] ] : adverse event reporting to IRBs : improving human subject protection
| Guidance for clinical investigators, sponsors, and IRBs [[electronic resource] ] : adverse event reporting to IRBs : improving human subject protection |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] |
| Descrizione fisica | 1 online resource (6 pages) |
| Soggetto topico |
Clinical trials - Reporting
Human experimentation in medicine Institutional review boards (Medicine) - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for clinical investigators, sponsors, and IRBs |
| Record Nr. | UNINA-9910699066203321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : granularity document : annex to M4, organization of the CTD
| Guidance for industry [[electronic resource] ] : granularity document : annex to M4, organization of the CTD |
| 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, , [2005] |
| Descrizione fisica | 10 pages : digital, PDF file |
| Soggetto topico | Clinical trials - Reporting |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698972603321 |
| 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, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : E2B(M), data elements for transmission of individual case study reports, questions and answers
| Guidance for industry [[electronic resource] ] : E2B(M), data elements for transmission of individual case study reports, questions and answers |
| 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, , [2005] |
| Descrizione fisica | 17 pages : digital, PDF file |
| Soggetto topico |
Clinical pharmacology
Clinical trials - Reporting Drugs - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698976403321 |
| 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, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : M4, the CTD, efficacy questions and answers
| Guidance for industry [[electronic resource] ] : M4, the CTD, efficacy questions and answers |
| 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, , [2004] |
| Descrizione fisica | 9 pages : digital, PDF file |
| Soggetto topico | Clinical trials - Reporting |
| Soggetto genere / forma | Electronic records. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698954003321 |
| 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, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : M4, the CTD, general questions and answers
| Guidance for industry [[electronic resource] ] : M4, the CTD, general questions and answers |
| 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, , [2004] |
| Descrizione fisica | 8 pages : digital, PDF file |
| Soggetto topico | Clinical trials - Reporting |
| Soggetto genere / forma | Electronic records. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698953803321 |
| 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, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : E2BM data elements for transmission of individual case safety reports
| Guidance for industry [[electronic resource] ] : E2BM data elements for transmission of individual case safety reports |
| 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, , [2002] |
| Descrizione fisica | 34 pages : digital, PDF file |
| Soggetto topico |
Clinical pharmacology
Clinical trials - Reporting Drugs - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698976003321 |
| 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, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : submitting marketing applications according to the ICH-CTD format, general considerations
| Guidance for industry [[electronic resource] ] : submitting marketing applications according to the ICH-CTD format, general considerations |
| 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 | 13, 1, 2 pages : digital, PDF file |
| Soggetto topico |
Drug approval
Drugs - Marketing Clinical trials - Reporting |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698953703321 |
| 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 | ||
| ||
Revision of the ICH guideline on clinical safety data management [[electronic resource] ] : data elements for transmission of individual case safety reports
| Revision of the ICH guideline on clinical safety data management [[electronic resource] ] : data elements for transmission of individual case safety reports |
| Pubbl/distr/stampa | [Rockville, MD] : , : [Center for Drug Evaluation and Research] : , : [Center for Biologics Evaluation and Research], , [2005] |
| Descrizione fisica | 25 pages : digital, PDF file |
| Soggetto topico |
Clinical pharmacology
Clinical trials - Reporting Drugs - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Revision of the ICH guideline on clinical safety data management |
| Record Nr. | UNINA-9910698976903321 |
| [Rockville, MD] : , : [Center for Drug Evaluation and Research] : , : [Center for Biologics Evaluation and Research], , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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