Info
- Utilizzare la checkbox di selezione a fianco di ciascun documento per attivare le funzionalità di stampa, invio email, download nei formati disponibili del (i) record.
Guidance for indusry [[electronic resource] ] : integrated summary of effectiveness
| Guidance for indusry [[electronic resource] ] : integrated summary of effectiveness |
| Pubbl/distr/stampa | Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) |
| Descrizione fisica | 13 pages : digital, PDF file |
| Soggetto topico |
Drugs - Effectiveness
Biologicals - Effectiveness |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for indusry |
| Record Nr. | UNINA-9910698759103321 |
| Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter
| Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter |
| Pubbl/distr/stampa | Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) |
| Descrizione fisica | i, 5 pages : digital, PDF file |
| Soggetto topico | Drugs - Microbiology - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698131003321 |
| Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : clinical pharmacology section of labeling for human prescription drug and biological products : content and format
| Guidance for industry [[electronic resource] ] : clinical pharmacology section of labeling for human prescription drug and biological products : content and format |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : , : Center for Biologics Evaluation and Research (CBER), , [2009] |
| Descrizione fisica | 11 pages : digital, PDF file |
| Soggetto topico |
Drugs - Labeling - United States
Biological products - Labeling - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698139103321 |
Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter
| Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter |
| Pubbl/distr/stampa | Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) |
| Descrizione fisica | i, 3 pages : digital, PDF file |
| Soggetto topico | Parenteral therapy |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698131703321 |
| Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : animal models : essential elements to address efficacy under the animal rule
| Guidance for industry [[electronic resource] ] : animal models : 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 (CDER) : , : Center for Biologics Evaluation and Research (CBER), , [2009] |
| Descrizione fisica | 19 pages : digital, PDF file |
| Soggetto topico |
Laboratory animals
Drugs - Effectiveness |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698135403321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : , : Center for Biologics Evaluation and Research (CBER), , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions, annex 1, residue on ignition/sulphated ash, general chapter
| Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions, annex 1, residue on ignition/sulphated ash, 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 (CDER) : , : Center for Biologics Evaluation and Research (CBER), , [2008] |
| Descrizione fisica | i, 3 pages : digital, PDF file |
| Soggetto topico |
Pharmacopoeias - Evaluation
Ash (Combustion product) |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698710203321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : , : Center for Biologics Evaluation and Research (CBER), , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : process validation, general principles and practices
| Guidance for industry [[electronic resource] ] : process validation, general principles and practices |
| Pubbl/distr/stampa | Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) |
| Descrizione fisica | 20 unnumbered pages : digital, PDF file |
| Soggetto topico |
Biologicals - Evaluation
Drugs - Testing Manufacturing processes - Evaluation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698126603321 |
| Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : tropical disease priority review vouchers
| Guidance for industry [[electronic resource] ] : tropical disease priority review vouchers |
| Pubbl/distr/stampa | Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) |
| Descrizione fisica | 9 pages : digital, PDF file |
| Soggetto topico |
Tropical medicine
Drugs - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698126203321 |
| Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : contents of a complete submission for the evaluation of proprietary names
| Guidance for industry [[electronic resource] ] : contents of a complete submission for the evaluation of proprietary names |
| Pubbl/distr/stampa | Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) |
| Descrizione fisica | i, 17 pages : digital, PDF file |
| Soggetto topico |
Drugs - Labeling - Evaluation
Brand name products - Evaluation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698127103321 |
| Silver Spring, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
