Pharmacokinetics (PK) is a fundamental component of the clinical drug development process. Understanding the basic PK and metabolism characteristics of the drug compound will eventually reveal the appropriate drug regimen for a patient. Before this milestone materializes, years of clinical design and research is needed with copious amounts of data generated from pharmacokinetics studies to establish the appropriate route of administration, safe and effective therapeutic doses, and the frequency and duration of dosing to sustain the intended therapeutic effects.
BIOPHARMA’S Pharmacokinetic TEAM
BioPharma’s team of Pharmacokinetic Scientists are experts in their field, having generated thousands of study designs to support drug submissions to multiple regulatory markets across the globe. The team is also responsible for developing innovative design solutions for all drug programs from generic equivalents to new drug candidates.
Dr. Janice Faulknor MD, CCFP, Medical Director and Principal Investigator – 15 years of research experience in HAP and Abuse Deterrent Assessment.
Dr. Isabella Szeto MD, CCFP, FCFP, CPI, PrincipalInvestigator – 13 years of clinical research experience with 200+ studies.
Dr. John Oldenhof, MSc, PhD, VP of Clinical Pharmacology – 18 years of experience having overseen 250+ early phase and HAP and Abuse
Deterrent Assessment studies
Shein Nanji, Manager of Subject Recruitment with over 10 years of experience building a robust database of recreational drug user.
All pharmacokinetic study designs, clinical trials and clinical development plans at BioPharma are supported by our panel of expert Medical Physicians that ensure foremost that the safety and well-being of our study volunteers is the priority. Whether the strategy is to dose a generic drug equivalent in healthy volunteers versus a patient panel or proceed with a new drug candidate, our Physician team’s primary objective is to maintain the health and welfare of our subjects with ethical and safety considerations driving their decisions. By understanding the drug product’s pharmacokinetics, pharmacodynamics, mechanism of action and potentially serious or adverse events, our Physicians provide safe, reliable, data-driven solutions to clinical development programs.