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Guidance for industry and review staff [[electronic resource] ] : labeling for human prescription drug and biological products : determining established pharmacologic class for use in the highlights of prescribing information
| Guidance for industry and review staff [[electronic resource] ] : labeling for human prescription drug and biological products : determining established pharmacologic class for use in the highlights of prescribing information |
| Pubbl/distr/stampa | Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research |
| Descrizione fisica | 1 electronic text (7 pages) |
| Soggetto topico |
Drugs - Labeling
Biologicals - Labeling |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and review staff |
| Record Nr. | UNINA-9910699378103321 |
| Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry and review staff [[electronic resource] ] : nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route
| Guidance for industry and review staff [[electronic resource] ] : nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2008] |
| Descrizione fisica | 1 electronic resource (8 pages) |
| Soggetto topico | Drugs - United States - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and review staff |
| Record Nr. | UNINA-9910696963303321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and review staff [[electronic resource] ] : recommended approaches to integration of genetic toxicology study results
| Guidance for industry and review staff [[electronic resource] ] : recommended approaches to integration of genetic toxicology study results |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] |
| Descrizione fisica | 1 online resource (5 pages) |
| Soggetto topico |
Genetic toxicology - United States
Drug development - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and review staff |
| Record Nr. | UNINA-9910696958303321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||