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Human Abuse Potential & Abuse Liability

Innovative and Comprehensive Solutions for Human Abuse Potential Studies

The opioid crisis has had devastating consequences of drug abuse that has become widely recognized. As many as 841,000 people have died from a drug overdose between 1999 and 2019.[i] This increased awareness has led to strict regulatory guidance for the assessment of Human Abuse Potential (HAP) of novel drugs. 

BioPharma Services, Inc. has extensive expertise in all essential areas necessary for performing HAP studies and Abuse Deterrent Assessment programs. BioPharma Services can also support our clients’ HAP programs competently and efficiently.

Comprehensive Experience with all CNS Compounds

 

Analgesics | Antidepressants | Anesthetics | Stimulants | Antiparkinsonian Agents

BioPharma’s Accomplished Human Abuse Potential Team

BioPharma’s core HAP team includes experienced abuse potential specialists that were involved in the first-in-human abuse potential studies conducted according to the principles of GCP during the early 2000s, prior to the introduction of the U.S. Food and Drug Administration’s (FDA) Guidance on Abuse Potential and Abuse Deterrent Assessment.[ii] Under the expert care and guidance of our Principal Investigator, Dr. Isabella Szeto, we have created innovative and safe study designs, including a strategy for the administration of 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 – over 15 years of clinical research experience and has conducted and overseen 200+ studies. She has played a key role in the success of multiple HAP programs and is an expert in the creation of innovative and safe study designs

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

Project Team – Our talented project team has over 10 years of experience conducting complex HAP studies and building a robust database of recreational drug users.

The Unique Strengths of BioPharma’s HAP Services

Why choose BioPharma Services for your Human Abuse Potential Study? Let us show you The BioPharma Benefits of working with a niche CRO with massive impact.

Clinical Trial Services

State of the art facilities. World class leaders. Innovative scientific expertise.

A Large Database of Study Volunteers

From protocol development through to regulatory submission, quality is a given – every step of the way.

Clinical Trial Recruitment

 

State-of-the-art Facilities

Two state-of-the-art clinical study sites with controlled substance licenses in Toronto, Canada and St. Louis, Missouri, that offer extensive safety monitoring.

Visit Us Virtually 

 

Pharmacy Expertise

Our team has extensive pharmacy compounding capabilities and has been involved in landmark studies on Abuse Deterrent Formulations (ADFs).

Pharmacy Capabilities 

 

Expert Regulatory Support

We competently guide and represent our clients to ensure compliance with all regulatory requirements for HAP studies.

Data Management Services

 

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State of the art facilities. World class leaders. Innovative scientific expertise

  • Dr. John Oldenhof, MSc, Ph.D., Chief Scientific Officer  Dr. Oldenhof has overseen 300+ early phase HAP and Abuse Deterrent Assessment studies. His 18-year tenure in clinical pharmacology has largely been dominated by his work on the design and execution of HAP programs that support the FDA’s mandate for abuse potential assessment of novel chemical entities and abuse deterrence of tamper-resistant technologies. His published work and experience include the development of novel methodologies and study designs, as well as direct collaboration with the US Food and Drug Administration (FDA) to advance HAP studies and pharmacometric 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
    preferred partners

Schedule a Discovery
Call Today

Complete the form to schedule a Discovery Call with one of our medical experts to learn how BioPharma Services can be your trusted clinical trial partner.