PKPD Incorporated is a specialized Clinical Pharmacology and Pharmacometric Research and Development Organization, providing advanced pharmacokinetic data analysis services to the pharmaceutical and biotechnology industry.
PKPD utilizes cutting edge, computer-based drug modeling and clinical trial simulation techniques to develop optimized dosing regimens during pre-clinical and clinical drug development.
PKPD builds models to link drug exposure (pharmacokinetics, PK) with drug response (pharmacodynamics, PD) and then integrates into the model estimates of patient variability. With these models PKPD is able to conduct advanced clinical trial simulations to predict the likely safety and efficacy of a given dose or dosing regimen. This approach enables “what-if” scenario’s to be conducted with multiple clinical trial designs thereby facilitating the design and selection of the optimal dosing regimen for Phase II (proof of concept) and Phase III (registration) studies.
Drug modeling and simulation has been recognized by the FDA as a “critical path” enabling technology that assists pharmaceutical and biotechnology companies in the selection of safe and effective dosing regimens for late stage clinical development and registration. The approach minimizes the costly risk of failure inherent in conventional, empirical dose selection techniques and provides an expedited route to approval through rational dose selection and efficient clinical trial design. This innovative and rational approach to drug development assists companies to more rapidly and safely advance new medicines to the marketplace for an earlier return on investment. PKPD Incorporated also provides consultancy services in drug metabolism, drug-drug interactions, ADME, toxicology/toxicokinetics, special patient population analyses, and pre-clinical/clinical pharmacology study designs from IND to NDA.