PK/PD Modeling & Simulation

PK/PD Modeling & Simulation

Regulatory agencies are responsible for approving all new drugs and for ensuring that all available drugs on the market are effective and safe for human use. Understanding the safety and effectiveness of any drug depends, in large part, on pharmacokinetics (PK), pharmacodynamics (PD), PK/PD modeling and simulation (M&S). Because of the growing emphasis placed on M&S analyses by regulatory authorities, and the wealth of information that these analyses provide, it is more important to consider where M&S can advance your drug development program. We offer following services:

• Population PK analysis
• PK exposure-response (E-R) analysis
• Concentration-QT analysis and modeling
• Dose selection and justification
• NONMEM data set preparation
• Identify intrinsic and extrinsic factors impacting PK exposure
• Dose simulations for different populations and formulations
• Submission-ready authoring report authoring