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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 | ||
| ||
Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region . Annex 3 Test for particulate contamination : subdivisible particles general chapter
| Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region . Annex 3 Test for particulate contamination : subdivisible particles 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, 6 pages : digital, PDF file |
| Soggetto topico |
Pharmacopoeias - Standards - International cooperation
Drugs - Analysis - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698866703321 |
| 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 4A Microbiological examination of nonsterile products : microbial enumeration tests general chapter
| Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region . Annex 4A Microbiological examination of nonsterile products : microbial enumeration tests 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
Health products - Microbiology - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698866403321 |
| 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 4B Microbiological examination of nonsterile products : tests for specified microorganisms general chapter
| Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region . Annex 4B Microbiological examination of nonsterile products : tests for specified microorganisms 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
Health products - Microbiology - Standards - International cooperation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698866003321 |
| 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 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 region . 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 : , : Center for Biologics Evaluation and Research, , [2008] |
| Descrizione fisica | i, 3 pages : digital, PDF file |
| Soggetto topico |
Pharmacopoeias - Standards - International cooperation
Ash (Combustion product) |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698867603321 |
| 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 | ||
| ||
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 | ||
| ||
