By Dr. Tom Zhang, Chief Scientist, Large Molecule Bioanalysis, Worldwide Clinical Trials
Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse. This is because the stages differ both in scale (small vs. large) and focus (safety vs. safety and efficacy).
Explore a few points to jumpstart your thinking as you approach this challenge.