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Animal models [[electronic resource] ] : essential elements to address efficacy under the animal rule
| Animal models [[electronic resource] ] : essential elements to address efficacy under the animal rule |
| 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], , [2008] |
| Descrizione fisica | 15 pages : digital, PDF file |
| Soggetto topico |
Laboratory animals
Drugs - Effectiveness |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Animal models |
| Record Nr. | UNINA-9910698771203321 |
| [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], , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Dose-response information to support drug registration [[electronic resource]]
| Dose-response information to support drug registration [[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], , [1994] |
| Descrizione fisica | 1 online resource (15 pages) |
| Collana | Guideline for industry |
| Soggetto topico |
Dose-response relationship (Biochemistry)
Drug approval - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910699262303321 |
| [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], , [1994] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
E 16 genomic biomarkers related to drug response [[electronic resource] ] : context, structure, and format of qualification submissions
| E 16 genomic biomarkers related to drug response [[electronic resource] ] : context, structure, and format of qualification submissions |
| Pubbl/distr/stampa | [Rockville, Md.?] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], , [2009] |
| Descrizione fisica | 1 online resource (9 pages) |
| Soggetto topico |
Genomics - United States
Biochemical markers - United States Drug approval - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | E 16 genomic biomarkers related to drug response |
| Record Nr. | UNINA-9910699265003321 |
| [Rockville, Md.?] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals [[electronic resource]]
| Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals [[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], , [2008] |
| Descrizione fisica | iii, 20 pages : digital, PDF file |
| Soggetto topico |
Clinical trials
Drugs - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals |
| Record Nr. | UNINA-9910698761603321 |
| [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 | ||
| ||
Manual del Centro para la Evaluacion e Investigacion de Farmacos [[electronic resource]]
| Manual del Centro para la Evaluacion e Investigacion de Farmacos [[electronic resource]] |
| Edizione | [[Rev. 03/16/01].] |
| 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 | 90 pages : digital, PDF file |
| Soggetto topico | Drugs - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Altri titoli varianti | Manual del CDER |
| Record Nr. | UNINA-9910698134903321 |
| [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 | ||
| ||
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions [[electronic resource] ] : annex 9, tablet friability general chapter
| Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions [[electronic resource] ] : annex 9, tablet friability general chapter |
| 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], , [2009] |
| Descrizione fisica | 1 online resource (3 pages) |
| Soggetto topico |
Pharmacopoeias - Standards - International cooperation
Tablets (Medicine) |
| 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-9910699240603321 |
| [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], , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Q8(R1) pharmaceutical development revision 1 [electronic resource]
| Q8(R1) pharmaceutical development revision 1 [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] : , : [Center for Biologics Evaluation and Research], , [2008?] |
| Descrizione fisica | 1 online resource (14 pages) : illustrations (some color) |
| Soggetto topico | Drug development - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Q8 |
| Record Nr. | UNINA-9910702187703321 |
| [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], , [2008?] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Quality of biotechnological products [[electronic resource] ] : analysis of the expression construct in cells used for production of r-DNA derived protein products
| Quality of biotechnological products [[electronic resource] ] : analysis of the expression construct in cells used for production of r-DNA derived protein products |
| 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 ( i, 4, 1 page) |
| Collana | Guideline for industry |
| Soggetto topico |
Biotechnology - Safety measures
Protein engineering |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Quality of biotechnological products |
| Record Nr. | UNINA-9910699239103321 |
| [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 | ||
| ||
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 | ||
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