Strategies for dose escalation during first-in-human studies are critical for volunteer safety and for study success. Decisions regarding dose escalation involve balancing three elements: risks to individual volunteers; risks of failing to identify the correct dose range to use in subsequent studies; and risks of delaying or stopping development of a potentially useful product. Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation offer a set of tools to increase the predictability of drug candidate performance. By identifying the best individualized dosing regimen to treat a given indication, patient outcomes can be improved, and the probability of a molecule’s success can be increased.

Authors: Professor Tim Mant, FRCP FFPM, Vice President, Medical Research and Principal Investigator, Quintiles & N. Seth Berry, PharmD, Director, Clinical PK/PD and Modeling & Simulation, Quintiles