First dose of potential new medicines to humans: how animals help

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