Guidance for industry [[electronic resource] ] : SUPAC-MR : modified release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation
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| Titolo: |
Guidance for industry [[electronic resource] ] : SUPAC-MR : modified release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation
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| Pubblicazione: | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [1997] |
| Descrizione fisica: | 1 electronic resource (ii, 36, 6, 6 pages) |
| Soggetto topico: | Solid dosage forms - United States - Testing |
| Drugs - Therapeutic equivalency - Documentation - United States | |
| Note generali: | "CMC 8." |
| "September 1997." | |
| Nota di bibliografia: | Includes bibliographical references (page 36). |
| Altri titoli varianti: | Guidance for industry |
| Titolo autorizzato: | Guidance for industry |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910697093403321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |