ABSTRACT
Toxicology studies in animals are carried out very early in the drug development process. Designing and analyzing data from these toxicokinetic and pharmacokinetic (PK) studies are part of the vast number of duties of nonclinical statisticians or biomarker statisticians. The clinical trial sponsor should consider the nonclinical safety/toxicological data requirements outlined in ICH M3(R2) guidance of the Food and Drug Administration to design the appropriate nonclinical toxicology/toxicokinetic studies to support a ‘proof of concept’ trial in humans. Calculating the number of animals needed for the preclinical tox study needs statistical guidance and input. For large animals, each animal is usually sampled per time point giving rise to a complete design. Rodent in-vivo toxicology studies are initiated and completed prior to clinical PK studies in humans. Drug exposure is measured by the area under the concentration × time curve or maximum concentration at the expected peak concentration time.
