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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 | ||
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Reviewer guidance [[electronic resource] ] : integration of study results to assess concerns about human reproductive and developmental toxicities
| Reviewer guidance [[electronic resource] ] : integration of study results to assess concerns about human reproductive and developmental toxicities |
| 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 | 1 electronic resource (26 pages) : charts |
| Soggetto topico |
Reproductive toxicology - United States
Developmental toxicology - United States Drugs - United States - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Reviewer guidance |
| Record Nr. | UNINA-9910696977803321 |
| 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 | ||
| ||
Reviewer guidance [[electronic resource] ] : validation of chromatographic methods
| Reviewer guidance [[electronic resource] ] : validation of chromatographic methods |
| Pubbl/distr/stampa | Rockville, MD : , : Center for Drug Evaluation and Research, , [1994] |
| Descrizione fisica | 1 electronic resource (ii, 30 pages) |
| Soggetto topico |
Drugs - Analysis - Government policy - United States
Chromatographic analysis - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Reviewer guidance |
| Record Nr. | UNINA-9910697097003321 |
| Rockville, MD : , : Center for Drug Evaluation and Research, , [1994] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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