Selection of the First-in-Human (FIH) dose and the Recommended Phase II Dose (RP2D) is a critical step in early clinical development. It links nonclinical findings to clinical trial design and provides the scientific basis for safe dose escalation and subsequent evaluation of therapeutic activity.
This service supports the identification and justification of FIH dose and RP2D based on nonclinical data, toxicology findings, and PK/PD analysis. It includes translational assessment, evaluation of exposure-response relationship, and integration of emerging Phase I data when available. The output is a clear, data-driven rationale for dose selection that can be incorporated into clinical protocols and regulatory documentation.
Key Questions Dose Identification Can Address
- What is a justified First-in-Human (FIH) starting dose?
- How should dose escalation be structured?
- Which dose should be recommended for Phase II (RP2D)?
Case Studies
