Regulatory Pharmacokinetics Analysis

Pharmacokinetics describes a drug’s absorption, distribution, metabolism, and excretion properties. Using a combination of biology, pharmacology and physiology training with mathematical and statistical methods we evaluate pharmacokinetic data and use it to guide critical decisions throughout the drug development process. Dose and dose frequency optimization, calculation of important pharmacokinetic parameters in various populations, and understanding the exposure-response relationship are examples of the critical tasks dependent on pharmacokinetic analysis.

Our Pharmacokinetic Services:

• Noncompartmental PK Analysis
• GLP Toxicokinetic Analysis and Reporting
• Designing and Interpreting Nonclinical and Clinical ADME Studies
• Preparation of toxicokinetic reports for regulatory Submission
• PK Guided Study Design and Dose Selection
• Population Pharmacokinetic Modeling
• Exposure Response Analysis