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Clinical safety data management [[electronic resource] ] : definitions and standards for expedited reporting
| Clinical safety data management [[electronic resource] ] : definitions and standards for expedited reporting |
| Pubbl/distr/stampa | [Rockville, Md.] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [1995] |
| Descrizione fisica | 1 online resource (ii, 11, 3 pages) |
| Collana | Guideline for industry |
| Soggetto topico |
Drugs - Dosage - United States
Drugs - Side effects - Reporting - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Clinical safety data management |
| Record Nr. | UNINA-9910699267803321 |
| [Rockville, Md.] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [1995] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
E2f development safety update report [[electronic resource]]
| E2f development safety update report [[electronic resource]] |
| Pubbl/distr/stampa | [Silver Spring, MD] : , : [Center for Drug Evaluation and Research] |
| Descrizione fisica | 33 pages : digital, PDF file |
| Soggetto topico | Drug development - Evaluation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Development safety update report |
| Record Nr. | UNINA-9910698736003321 |
| [Silver Spring, MD] : , : [Center for Drug Evaluation and Research] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The extent of population exposure to assess clinical safety [[electronic resource] ] : for drugs intended for long-term treatment of of non-life threatening conditions
| The extent of population exposure to assess clinical safety [[electronic resource] ] : for drugs intended for long-term treatment of of non-life threatening conditions |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [1995] |
| Descrizione fisica | 1 online resource (4 pages) |
| Collana | Guideline for industry |
| Soggetto topico |
Drugs - Dosage - United States
Drugs - Side effects - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Extent of population exposure to assess clinical safety |
| Record Nr. | UNINA-9910699268403321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [1995] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
PDUFA pilot project [[electronic resource] ] : proprietary name review
| PDUFA pilot project [[electronic resource] ] : proprietary name review |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [2008] |
| Descrizione fisica | 38 pages : digital, PDF file |
| Soggetto topico | Business names - Evaluation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | PDUFA pilot project |
| Record Nr. | UNINA-9910698125503321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions [[electronic resource] ] : annex 5, disintegration test general chapter
| Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions [[electronic resource] ] : annex 5, disintegration test general chapter |
| Pubbl/distr/stampa | [Silver Spring, MD] : , : [Center for Drug Evaluation and Research] |
| Descrizione fisica | 5 unnumbered pages : digital, PDF file |
| Soggetto topico |
Tablets (Medicine) - Testing
Capsules (Pharmacy) - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions |
| Record Nr. | UNINA-9910698737203321 |
| [Silver Spring, MD] : , : [Center for Drug Evaluation and Research] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter [[electronic resource] /] / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
| Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter [[electronic resource] /] / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [2007] |
| Descrizione fisica | 4 unnumbered pages : digital, PDF file |
| Soggetto topico | Parenteral therapy |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter |
| Record Nr. | UNINA-9910698901303321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Q4B, annex 3, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles [[electronic resource] /] / International Conference on Harrmonisation of Technical Requrements for Registration of Pharmaceuticals for Human Use
| Q4B, annex 3, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles [[electronic resource] /] / International Conference on Harrmonisation of Technical Requrements for Registration of Pharmaceuticals for Human Use |
| Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [2007] |
| Descrizione fisica | 7 unnumbered pages : digital, PDF file |
| Soggetto topico | Drugs - Microbiology - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles |
| Record Nr. | UNINA-9910698901103321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
