Guiding dose selection

Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late‐stage attritions in clinical development.

At every stage of your development, relevant pharmacometric approaches can be properly developed to guide dose selection

At preclinical and translational steps

  • Scaling PK/PD animal data to humans
  • Translation modeling (in vitro-in vivo, interspecies, preclinical to clinical) using PBPK models
  • Identify exposure-safety, exposure-PD, and exposure-activity relationships
  • Establish early view on drug-drug interactions (DDI) using PBPK models
  • FIH dose justification
  • First-in-Human Simulation incorporating Target-Mediated Drug Disposition (TMDD) for a Biologic

During your Phase I/II program execution

PhinC Development can support your dose and regimen selection by bridging Phase 1 PK/PD data using pharmacometrics and quantitative systems pharmacology models.

Dose selection for phase III trials

This dose selection should be informed by well‐designed dose‐finding studies. PhinC Development supports you with appropriate methods for study design optimization like Fisher Information Matrix (FIM)‐based methods, clinical trial simulations or adaptive studies.

See also Dose Selection in special population (pediatric, elderly, …).
 

Club Phase 1
GMP - Groupe de Métabolisme et Pharmacocinétique
EUFEMED
AFSSI