Abstract

The need for careful testing of new drugs in animal models before study in humans has been recognised by physicians since the First World War. Now, first human studies on new drugs are subject to detailed government guidelines, which in the European Union are presently being reinforced through the wide-ranging Clinical Trials Directive. However, despite their long history and widespread application, these guidelines are empirical and have been formulated with a paucity of critical scientific evidence. Here, we review the principles and the available, albeit limited, evidence that support the design and conduct of preclinical studies in a way that permits effective and safe first-dose studies of potential new medicines in humans.

Author affiliations

1. Medical Research Council Toxicology Unit, Hodgkin Building, University of Leicester, Lancaster Road, Leicester LE1 9HN, UK.
2. Marix Drug Development, Rhodfa Marics, Llantrisant, CF72 8UX, UK.
3. Pfizer Clinical Research Unit, Kent and Canterbury Hospital, Ethelbert Road, Canterbury, Kent CT1 3NG, UK.

Correspondence to: Peter Greaves¹ Email: pg29@le.ac.uk

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