Smarter, patient-led drug development decisions for a smoother journey to market.
Together, quantitative clinical pharmacology, pharmacometrics and programming ensuring a more strategic approach to clinical development, ultimately helping investigators match the right patient to the right treatment at the right dose. By leveraging pharmacokinetic and pharmacodynamic information (safety and efficacy) to understand the relationship between drugs, disease, and patients, our solutions guide clinical trial design, dose selection, and target population identification. These insights help determine the optimal drug to deliver the greatest benefit to the patients with the fewest unwanted side effects, thus minimizing the patient burden and eventually reducing the time and cost of bringing promising treatments to market.
Solution Highlights
Quantitative clinical pharmacology
- Regulatory submissions & labeling to ensure compliance with regulations at all levels
- Bioequivalence and biosimilar development strategies
- Pediatric development (PIP/PSP)
- First-in-human dose selection, clinical study design, and dose escalation support (including power model analysis)
- Clinical study designs (e.g., food effect, drug-drug interactions, special populations, QT risk assessment, etc)
- Gap analysis and due diligence
- Expert interpretation of clinical PK data
Pharmacometrics
- Strategic implementation of model-informed drug development
- Population Pharmacokinetic (PopPK) Modeling
- Population pharmacokinetic-pharmacodynamic (PK-PD) analyses for efficacy and safety
- Exposure-Response (ER) analyses for efficacy and safety
- Physiologically based Pharmacokinetic (PBPK) modeling
- Dose and dosing regimen selection and justification
- Disease & placebo models
- Virtual population studies
- Reporting and data analysis/management in a secure, regulatory-compliant format
- Use of state-of-the-art methodologies
PK analysis & programming
- Non-compartmental PK analysis
- PK/PD programming support (SAS/R)
- NONMEM dataset generation (for popPK, popPK-PD, ER)
The path to smarter drug development begins with Parexel’s quantitative clinical pharmacology, pharmacometrics, and PK analysis & programming.