Clinical Pharmacology – Chemical
2019 PharmSci 360
This presentation will describe key clinical pharmacology questions to address during drug development and regulatory review. Critical areas will include how intrinsic factors (age, gender, genetics, organ function) and extrinsic factors (concomitant drug administration) may affect individual patients' PK, PD, and drug response. Data critical to have during drug development and review and post-approval will be discussed. How real world data and real world evidence can help address individual patient dosing will be presented.