This white paper explores translational pharmacology and how to ensure safe and effective dosing of an investigational medicinal product (IMP) in clinical trials. The relationship between dose, systemic exposure, safety and efficacy are critical to demonstrate a favorable risk/benefit relationship at each development milestone.
Although safety is the main focus in the preclinical studies and early clinical trials, sponsors should also be thinking in terms of defining the relationship between dose, exposure and efficacy.
The importance of a preclinical and clinical pharmacokinetics (PK) strategy in a successful clinical trial design is critical for:
- designing a preclinical pharmacology-toxicology program;
- designing successful clinical trials;
- achieving a positive benefit/risk balance supporting licensure;
- establishing an effective post-marketing and pharmacovigilance program.