Assessment of value and applications of in vitro testing of topical dermatological drug products

The FDA recently issued a guidance covering practices of scaleup and post approval changes with semisolids (SUPAC-SS). This guidance outlines the steps that must be taken by a company to maintain certification of its semisolid dermatological products after quantitative changes have been made in thei...

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Veröffentlicht in:	Pharmaceutical research 1999-09, Vol.16 (9), p.1325-1330
Hauptverfasser:	FLYNN, G. L, SHAH, V. P, SWARBRICK, J, WANG, J. C. T, YACOBI, A, ZATZ, J. L, TENJARLA, S. N, CORBO, M, DEMAGISTRIS, D, FELDMAN, T. G, FRANZ, T. J, MIRAN, D. R, PEARCE, D. M, SEQUEIRA, J. A
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Topical Biological and medical sciences Drug Industry - legislation & jurisprudence Drug Industry - standards General pharmacology Guidelines as Topic Humans In Vitro Techniques Medical sciences Ointments - administration & dosage Ointments - pharmacokinetics Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Skin Diseases - drug therapy Skin, nail, hair, dermoskeleton United States United States Food and Drug Administration - standards
Online-Zugang:	Volltext
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