Pharmacometrics

We offer advanced mathematical modeling and statistical analyses to optimize drug development and improve patient outcomes. Our expert team provides tailored solutions in Population PK and PD modeling, exposure-response analysis, disease progression modeling, model-based meta-analysis, clinical trial simulations, and regulatory support. We have extensive experience providing quantitative decision-making guidance for pediatric studies, special populations, and rare disease indications. A model-informed drug development (MIDD) strategy with A2-Ai can help to…

• Arrive at the correct dose faster, and avoid unnecessary expense of studying the wrong dose levels
• Reduce trial group sizes, allowing faster completion
• Accelerate timelines to reach a go/no-go decision

Preclinical

We provide a diverse range of analysis approaches for preclinical programs, depending on your needs:

1. Projects informing IND & Pre-IND
2. Physiological-Based PK (PBPK) analysis
3. Non-compartmental analysis (NCA)
4. Translational modeling/simulation

Phase 1 + 2

Engage us for a range of modeling and simulation approaches such as Population PK/PD modeling, exposure-response, and C-QTc to guide quantitative decision-making for your Phase I/II program:

1. Dose selection
2. Study design
3. Clinical trial simulation
4. Drug-Drug interactions
5. Bioavailability/Equivalence

Phase 3 + 4

Our comprehensive modeling and statistical analysis support can inform many aspects of your late phase development, such as:

1. Pharmacometrics analyses to support regulatory submissions
2. Clinical Study Reports
3. Exposure-Response assessments for efficacy and safety
4. Risk/benefit assessments for NDA/BLA submissions
5. Phase 3 dosing defense
6. Labeling language
7. Approvals for unstudied doses