Early phase pharmacokinetic studies continue to be challenging. Current issues from regulatory, CRO/Sponsor, and site perspectives will be discussed and suggestions for optimizing protocols and operations will be presented.
Learning Objective : Describe the design challenges of special population studies; Develop practical solutions to special population study obstacles.
Critical Challenges in Conducting PK Studies in Patients and Special Populations
Charu Gautam, MD
Head- Early Clinical Development, Asia Pacific
Special Population Studies: Thirty Years Experience Shared
Harry Alcorn, PharmD
Chief Scientific Officer
DaVita Clinical Research, United States