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Adverse Events Associated with Oral First-in-Man Administration of New Chemical Entities Compared with Placebo – An Analysis of 14 Single- and Multi-Dosing, Double-Blind, Placebo-Controlled StudiesBy Rahul S Dimber, Peter Dewland
Abstract: This investigation is a retrospective analysis of the adverse events (AEs) associated with oral administration of new chemical entities (NCEs)for the first time in humans. We gathered data from 14 single- and multiple-dosings of FIM NCE studies conducted in our centre over a period of 5 years. In total, 452 subjects were dosed. A total of 2280 doses were administered. Active medication was given on 1763 dosing occasions and placebo …
Published in Research and Reviews: A Journal of Toxicology · Vol. 2, Issue 3, 2012 · pp. 1–6 Read article →