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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 | ||
| ||
Guideline for industry [[electronic resource] ] : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility
| Guideline for industry [[electronic resource] ] : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility |
| Pubbl/distr/stampa | [Rockville, MD] : , : [Center for Drug Evaluation and Research] : , : [Center for Biologics Evaluation and Research], , [1996] |
| Descrizione fisica | i, 3 pages : digital, PDF file |
| Soggetto topico |
Fertility - Effect of drugs on
Drugs - Toxicology |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guideline for industry |
| Record Nr. | UNINA-9910698977603321 |
| [Rockville, MD] : , : [Center for Drug Evaluation and Research] : , : [Center for Biologics Evaluation and Research], , [1996] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions . Annex 5 Disintegration test general chapter [[electronic resource]]
| Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions . Annex 5 Disintegration test general chapter [[electronic resource]] |
| Edizione | [[Draft].] |
| Pubbl/distr/stampa | [College Park, Md.?] : , : [Center for Drug Evaluation and Research], , [2008] |
| Descrizione fisica | 6 unnumbered pages : digital, PDF file |
| Soggetto topico |
Solid dosage forms - Mechanical properties - Standards - International cooperation
Pharmacopoeias - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Disintegration test general chapter |
| Record Nr. | UNINA-9910698865503321 |
| [College Park, Md.?] : , : [Center for Drug Evaluation and Research], , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions . Annex 7 Dissolution test general chapter [[electronic resource]]
| Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions . Annex 7 Dissolution test general chapter [[electronic resource]] |
| Edizione | [[Draft].] |
| Pubbl/distr/stampa | [College Park, Md.?] : , : [Center for Drug Evaluation and Research], , [2008] |
| Descrizione fisica | 3 pages : digital, PDF file |
| Soggetto topico |
Drugs - Solubility - Standards - International cooperation
Pharmacopoeias - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Dissolution test general chapter |
| Record Nr. | UNINA-9910698858603321 |
| [College Park, Md.?] : , : [Center for Drug Evaluation and Research], , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions . Annex 6 Uniformity of dosage units general chapter [[electronic resource]]
| Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions . Annex 6 Uniformity of dosage units general chapter [[electronic resource]] |
| Edizione | [[Draft].] |
| Pubbl/distr/stampa | [College Park, Md.?] : , : [Center for Drug Evaluation and Research], , [2008] |
| Descrizione fisica | 3 pages : digital, PDF file |
| Soggetto topico |
Drugs - Dosage - Standards - International cooperation
Pharmacopoeias - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Uniformity of dosage units general chapter |
| Record Nr. | UNINA-9910698865403321 |
| [College Park, Md.?] : , : [Center for Drug Evaluation and Research], , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions . Annex 8 Sterility test general chapter [[electronic resource]]
| Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions . Annex 8 Sterility test general chapter [[electronic resource]] |
| Edizione | [[Draft].] |
| Pubbl/distr/stampa | [College Park, Md.?] : , : [Center for Drug Evaluation and Research], , [2008] |
| Descrizione fisica | 10 pages : digital, PDF file |
| Soggetto topico |
Sterilization - Standards - International cooperation
Pharmacopoeias - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Sterility test general chapter |
| Record Nr. | UNINA-9910698858503321 |
| [College Park, Md.?] : , : [Center for Drug 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 | ||
| ||
Revision of the ICH guideline on clinical safety data management [[electronic resource] ] : data elements for transmission of individual case safety reports
| Revision of the ICH guideline on clinical safety data management [[electronic resource] ] : data elements for transmission of individual case safety reports |
| Pubbl/distr/stampa | [Rockville, MD] : , : [Center for Drug Evaluation and Research] : , : [Center for Biologics Evaluation and Research], , [2005] |
| Descrizione fisica | 25 pages : digital, PDF file |
| Soggetto topico |
Clinical pharmacology
Clinical trials - Reporting Drugs - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Revision of the ICH guideline on clinical safety data management |
| Record Nr. | UNINA-9910698976903321 |
| [Rockville, MD] : , : [Center for Drug Evaluation and Research] : , : [Center for Biologics Evaluation and Research], , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
