[Active ingredients, pharmaceutic aids and efficacy of topical drugs].
In local therapy, in contrast to all other forms of therapy, the galenic vehicle or various so-called inactive ingredients can influence the efficacy of the preparations to a great extent. This means that when such drugs are licensed, i.e. when their efficacy and safety are investigated, the therapeutic effects of the total compound under clinical conditions should form the basis for judgement, and not the pharmacological profile of the active substance alone. Taking these point into consideration, the value of application in phases, vehicle tolerance and the therapeutic properties of inactive ingredients, as compared with active ingredients, are assessed in relation to the range of indications of drugs. In this connection, the efficacy of generic products and the declaration of so-called inactive ingredients are discussed.
Zesch
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Institut für Arzneimittel des Bundesgesundheitsamtes Berlin.
D003879:Dermatologic Agents / Q000592:standards*; D004341:Drug Evaluation; D006801:Humans; D014677:Pharmaceutical Vehicles / Q000494:pharmacology* / Q000592:standards; D012867:Skin / Q000187:drug effects*
D003879:Dermatologic Agents; D014677:Pharmaceutical Vehicles
Wirkstoffe, Hilfsstoffe und Wirksamkeit von Externa-Fertigarzneimitteln.