Pharmacometrics

Pharmacometrics

Regulatory agencies are responsible for approving all new drugs and 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 regulatory authorities increasingly emphasize M&S analyses and the wealth of information they provide, it is essential to consider M&S to advance your drug development program.  XP Pharma Consulting has expertise in M&S analysis and reporting. We can work with you to optimize dose and regimen, improve the probability of success, and ensure ideal labeling, prescribing, and an optimal patient experience. 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