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Guidance for industry [[electronic resource] ] : integrated summaries of effectiveness and safety : location within the common technical document
| Guidance for industry [[electronic resource] ] : integrated summaries of effectiveness and safety : location within the common technical document |
| 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 | 7 pages : digital, PDF file |
| Soggetto topico |
Drugs - Effectiveness - United States
Biologicals - Effectiveness - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698895903321 |
| [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 | ||
| ||
Guidance for industry [[electronic resource] ] : standards for securing the drug supply chain : standardized numerical indentification for prescription drug packages
| Guidance for industry [[electronic resource] ] : standards for securing the drug supply chain : standardized numerical indentification for prescription drug packages |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner : , : Center for Drug Evaluation and Research (CDER) : , : Center for Biologics Evaluation and Research (CBER) : , : Office of Regulatory Affairs, , [2009] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico | Drugs - Packaging |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698135903321 |
Guidance for industry [[electronic resource] ] : assay development for immunogenicity testing of therapeutic proteins
| Guidance for industry [[electronic resource] ] : assay development for immunogenicity testing of therapeutic proteins |
| 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 (20 pages) : illustrations |
| Soggetto topico |
Immunogenetics - United States
Biological assay Proteins - Therapeutic use - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696923303321 |
| 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 | ||
| ||
Guidance for industry [[electronic resource] ] : residual solvents in drug products marketed in the United States
| Guidance for industry [[electronic resource] ] : residual solvents in drug products marketed in the United States |
| 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 electronic resource (6 pages) |
| Soggetto topico |
Solvents - United States
Drug adulteration - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910697097203321 |
| 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 for industry [[electronic resource] ] : SPL standard for content of labeling technical Qs & As
| Guidance for industry [[electronic resource] ] : SPL standard for content of labeling technical Qs & As |
| 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 (9 pages) |
| Soggetto topico | Drugs - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699293703321 |
| 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 | ||
| ||
Guidance for industry [[electronic resource] ] : presenting risk information in prescription drug and medical device promotion
| Guidance for industry [[electronic resource] ] : presenting risk information in prescription drug and medical device promotion |
| 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 electronic resource (24 pages) |
| Soggetto topico |
Drugs - Side effects - United States
Advertising - Drugs - United States Advertising - Medical instruments and apparatus |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696947903321 |
| 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 for industry [[electronic resource] ] : dosage delivery devices for OTC liquid drug products
| Guidance for industry [[electronic resource] ] : dosage delivery devices for OTC liquid drug products |
| 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 (10 pages) : illustrations |
| Soggetto topico |
Drugs - Dosage - United States
Drug delivery systems - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910703824503321 |
| 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 for industry [[electronic resource] ] : somatic cell therapy for cardiac disease
| Guidance for industry [[electronic resource] ] : somatic cell therapy for cardiac disease |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [2009] |
| Descrizione fisica | ii, 22 p : digital, PDF file |
| Soggetto topico |
Somatic cells
Cellular therapy - Government policy - United States Heart - Diseases - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698801903321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [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 region . Annex 4C Microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter
| Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region . Annex 4C Microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use 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 | i, 3 pages : digital, PDF file |
| Soggetto topico |
Pharmacopoeias - Standards - International cooperation
Drugs - Microbiology - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698865703321 |
| 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 | ||
| ||
Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region . 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 region . Annex 2 Test for extractable volume of parenteral preparations 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 | i, 3 pages : digital, PDF file |
| Soggetto topico |
Pharmacopoeias - Standards - International cooperation
Parenteral solutions - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698867203321 |
| 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 | ||
| ||
