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Record Nr. |
UNINA9910697093403321 |
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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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Pubbl/distr/stampa |
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Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [1997] |
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Descrizione fisica |
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1 electronic resource (ii, 36, 6, 6 pages) |
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Soggetti |
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Solid dosage forms - United States - Testing |
Drugs - Therapeutic equivalency - Documentation - United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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"CMC 8." |
"September 1997." |
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Nota di bibliografia |
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Includes bibliographical references (page 36). |
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