A set of 52 cards containing questions and answers about best practices relating to the conduct of Phase I studies. The questions are based on “Guidelines for Phase I Trials”, Association of the British Pharmaceutical Industry (ABPI), September 2007 and European Medicines Agency 2007 “Guideline on Strategies to Identify and Mitigate Risks For First-in-human Clinical Trials with Investigational Medicinal Products” (EMEA/CHMP/SWP/28367/07). Still Good Practice May 2014.
Ideal for all members of a Phase I unit, as well as monitors, auditors and ethics committee members.
Best Practices for Phase I studies
- Product Code: Best Practices for Phase I studies
- Availability: In Stock