Our Services
We provide quantitative solutions to key issues that clients face throughout the clinical development process, including:
| Phase of Development | Our Typical Services |
| Phase 1 through Proof-of-Concept |
• Support FIH designs by bridging animal PKPD data and predecessor compounds • Clinical Pharmacology Quantitative PK/PD Evaluation • Support PoC designs by modeling the time-course of disease, the compound effect, and the effect of patient variables. Evaluate PoC success criteria. • Support strategies to evaluate Proof of Mechanism |
| Proof-of-concept through pre-NDA activities | • Support dose and regimen selection trials by bridging Phase 1 PKPD data and predecessor compounds • Support expansion into new indications by bridging across indication. • Define the efficacy and/or safety margin vs. comparators by performing a comprehensive safety/efficacy evaluation utilizing literature data. • Develop and implement strategic modeling and simulation plans that are integrated into the Clinical Development Plan • Develop criteria for interim analysis. Evaluate innovative designs. • Population PK and exposure-response design • Support regulatory interactions |
| Registration activities | • Dose justification • Population PK analysis • Exposure-response analysis • Support response to regulatory questions |
| Post-marketing | • Comprehensive safety/efficacy evaluation including comparison of double-blind and open-label trials. • Support publication strategy |
| Other | • Special populations - support pediatric trial designs • Special populations - PKPD bridging to Asia • IVIVC • OTC, generics |
Learn more about the advantages of Quantitative Solutions’ services.
Read about how large pharmaceutical companies perceive the role of modeling and simulation in drug development.
Learn more about how FDA view the impact of pharmacometrics on drug approval and labeling decisions.