Human Abuse Potential & Abuse Liability
From our inception in 2006, BioPharma has amassed extensive experience in the conduct of first in human (FIH) clinical trials and clinical studies in opioids, narcotics and cannabinoid products. Our team has extensive experience with CNS products, Human Abuse Potential (HAP) and Abuse Deterrent Assessment programs and has the capability to support your human abuse potential programs. Learn more about our award winning team.
BioPharma’s Human Abuse Potential TEAM
BioPharma’s Human Abuse Potential team consists of a core team of Human Abuse Potential specialists that have been involved in the very first in human abuse potential studies conducted under GCP in the early 2000s, and prior to the introduction of the FDA Guidances on Human Abuse Potential and Abuse Deterrent Assessment. Under the expert care and guidance of our Principal Investigator, Dr. Isabella Szeto, we have created innovative and safe solutions to conduct first in human studies such as propofol in healthy volunteers. Learn more about our award winning team.
Medical Director and Principal Investigator with
15 years of research experience in Human Abuse Potential and Abuse Deterrent Assessment.
Dr. Isabella Szeto MD, CCFP, FCFP, CPI,
Principal Investigator – 15 years of early phase clinical research experience with 200+ studies.
Dr. John Oldenhof, MSc, PhD,
Chief Scientific Officer – over 18 years of experience having overseen 300+ early phase clinical research and Human Abuse Potential and Abuse Deterrent Assessment studies
with over 10 years of experience building a robust database of recreational drug users.
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State of the art facilities. World class leaders. Innovative scientific expertise
Dr. Oldenhof’s 18 year tenure in clinical pharmacology has largely been dominated by his work on the design and execution of Human Abuse Potential programs to support the FDA’s mandate for assessing the Human Abuse Potential of novel chemical entities and abuse deterrence for tamper-resistant technologies. His published work and experience includes the development of novel methodologies, innovative phase 1 trial designs and direct collaboration with the US Food and Drug Administration (FDA) to advance food effect studies, human abuse potential studies and pharmacometrics analyses.
- Regulatory consultation
- Protocol design and development
- Clinical study execution
- Recreational drug user recruitment
- Clinical Trial Data Management
- Biostatistical analysis and Statistical Analysis Plan (Development)
- Interpretation and report writing
- Ancillary services are also provided through our