Nonclinical safety assessment of Efinaconazole Solution (10%) for onychomycosis treatment

•Efinaconazole administered dermally to mice, rats and minipigs was well tolerated.•Reversible mild skin irritation after efinaconazole and vehicle dermal treatment.•Target organ of systemic toxicity was liver (vacuolation) in rats dosed dermally.•Efinaconazole was not carcinogenic in a 2-year mouse...

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Veröffentlicht in:	Regulatory toxicology and pharmacology 2014-10, Vol.70 (1), p.242-253
Hauptverfasser:	Jo, William, Glynn, Marian, Nejishima, Hiroaki, Sanada, Hisakazu, Minowa, Kenji, Calvarese, Barry, Senda, Hisato, Pillai, Radhakrishnan, Mutter, Linda
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Cutaneous Administration, Topical Animals Antifungal Antifungal Agents - administration & dosage Antifungal Agents - toxicity Dose-Response Relationship, Drug Efinaconazole Female Injections, Subcutaneous Male Mice Mice, Inbred ICR No-Observed-Adverse-Effect Level Onychomycosis Onychomycosis - drug therapy Pharmaceutical Solutions Rats Rats, Sprague-Dawley Safety assessment Skin - drug effects Swine Swine, Miniature Time Factors Toxicity Triazoles - administration & dosage Triazoles - toxicity
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