EMA updates first-in-human guidance

In newly released draft guidance, EMA outlined revised strategies to identify and reduce risks in first-in-human testing, emphasizing the use of non-clinical pharmacokinetic, pharmacodynamic and toxicology data in forming risk assessments.

The guidance took into account comments received on a concept paper published in July that encouraged better integration of toxicology data. The document noted prior guidance focused on single-ascending dose designs rather than on integrated protocols that are now commonly used (see BioCentury Extra, July 21)...