The First Time (dose) in Man (FTIM) of a new compound is a singular occasion having detrimental consequences if not approached correctly. DMC has extensive experience in all pre-clinical PK domains from 6 completed projects for big pharmaceutical companies using animal data to successfully achieve FTIM. All pre-clinical to FTIM work at DMC follows the “Minimum Anticipated Biological Effect Level” (MABEL) paradigm, based on circulating drug concentrations and PK/PD analysis. These methods are contrasted with physiological model based and classical regression allometry models.

Our pre-clinical to FTIM team performs:
• Protocol preparation and optimization
• Toxicokinetic / Pharmacokinetic analysis
• Noncompartmental Analyses (NCA)
• Allometric Scaling – FTIM
• Population pharmacokinetic allometric scaling including trial simulation
• Regulatory reporting