The solid organ transplantation landscape in Chile: a focus on basic and clinical research.

Drug development focused on the central nervous system space has been increasingly active; particularly since 2005 where one notes an acceleration of the number of phase II and III trials starts (). Central nervous system disorder study starts per year as derived from ClinTrials.Gov. In response to this increase in investigational new drug and new drug applications, the Food and Drug Administration (“The Agency”; FDA) produced a draft guidance on . Their rationale was that driving reflected a complex behavior requiring attention and executive function and that monitoring for potential drug-induced effects on this activity would be a final stage in a tiered strategy of safety monitoring, for example, receptor and nonclinical observations in the pre-IND phase, through clinical observations in large phase II and III patient trials. Ultimately, this surrogate testing could result in a formal Driving Test if the data suggested that a greater degree of characterization was needed (c.f., Ref. 3). Within the Guidance, the agency suggested five