First in Human Studies - ABPI

First in Human Studies : Points to Consider in Study Placement, Design and ConductJanuary 2011 AcknowledgementsThe primary authors were: Pauline Williams, DamianO'Connell, and Odile article was produced under the auspices of theABPI Experimental Medicine Expert Network. The authors based the article on FIH guidelines thathad been produced within GSK and Pfizer. The authors thank David Sciberras, Cyril Clarke,Corinne Cummings, Jo Collier, Juliet McColm, GerryParker and Oliver Schmidt from the Network forreview, and Jan de Hoon for external in Human (FIH) clinical trials are part of theexploratory phase of drug development and represent asignificant milestone in the clinical development of newmedicines. When only preclinical data are available toguide dose-selection, population, study design, safetymonitoring and appropriate expertise are all critical tomaximise the safety of the study subjects and thequality of the has been intense focus on the risks of FIHclinical trials since the TeGenero TGN1412 incident in2006, and much has been published on the evidenceand recommendations [1, 2, 3, 4].

Introduction First in Human (FIH) clinical trials are part of the exploratory phase of drug development and represent a significant milestone in the clinical development of new

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