Early Phase Research - First in Human
CRI Lifetree offers high-quality expertise and experience in the conduct of first in human studies involving the measurements of pharmacodynamic parameters.
Our Phase 1 team has performed more than 200 clinical studies, including First-in-Human (FIH) studies for biologics, reformulations and new chemical entities. In addition to measuring safety and pharmacokinetic parameters, we can provide expert advice on selecting the most appropriate pharmacodynamic evaluations for your compound.
Accurate and well-interpreted pharmacodynamic data can expedite the subsequent evaluation of investigational drugs. By delivering science-driven solutions to phase I safety and pharmacologic questions, CRI Lifetree can help facilitate more confident decisions to accelerate product development.
- First in Human and First in Patient, Single Ascending Dose / Maximum Tolerated Dose
- Multiple Ascending Dose
- Full PK/PD collections in plasma, urine, and CSF
- Safety/tolerability, optimal dosing schedules and MTD in target populations
- Cardiac Safety (QTc) evaluations
- Abuse Liability Studies
- Drug-Drug Interactions
- Bioavailability/Bioequivalence Studies
- Dose Proportionality Studies