Course Overview
This course equips students to navigate the regulatory, scientific, and ethical landscape of pharmaceutical and health product development. Students will examine how drugs and biomedical products move from discovery through clinical approval, the frameworks that govern that process nationally and internationally, and the professional opportunities the industry offers. Topics include the history and purpose of drug regulation, the drug development pipeline, pharmacokinetics and pharmacoeconomics, biotechnology applications, clinical trials, compliance and documentation, ethics, intellectual property, and career pathways.
Prerequisite(s)
- No prerequisites are required for this course.
Credits
3.0
- Not offered this term
- This course is not offered this term. Notify me to receive email notifications when the course opens for registration next term.
Learning Outcomes
Upon successful completion of this course, the student will be able to:
- Explain the public health goals for pharmaceutical regulation, with reference to landmark regulatory failures.
- Apply graphical and written communication techniques to present and interpret pharmacological and laboratory data.
- Use discipline-specific vocabulary accurately to describe pharmaceutical development.
- Analyze case studies of drug development successes and failures to evaluate the causes of failure, and the role of compliance and scientific caution.
- Evaluate the implications of intellectual property rights and licensing for biomedical innovation.
- Understand and practice good documentation and laboratory record keeping.
- Distinguish the stages of discovery, proof of concept, and clinical trials, and identify key decisions at each stage.
- Evaluate the clinical trials process as a framework for assessing the safety and efficacy of new drugs and devices.
- Compare regulatory pathways and approval barriers across product types and jurisdictions.
- Describe the key factors in successful drug development, including target screening, pharmacokinetics, and pharmacoeconomics.
- Explain how biotechnology tools are applied in compound and target identification.
- Describe the structure and function of CROs and the role of outsourcing in clinical development.
- Assess the current and emerging landscape of biotechnology-derived biomedical products.
- Evaluate ethical principles governing clinical trials, including informed consent, risk-benefit analysis, and equity in participant selection, with reference to historical breaches (e.g., Tuskegee, thalidomide, HIV from factor IIIV).
- Identify career pathways in the biotechnology and pharmaceutical industries, including non-R&D roles.
Effective as of Fall 2026
Related Programs
Introduction to Pharmaceutical Development (BIOT 3250) is offered as a part of the following programs:
- Indicates programs accepting international students.
- Indicates programs with a co-op option.
- Indicates programs eligible for students to apply for Post-graduation Work Permit (PGWP).
School of Health Sciences
- Honours in Biotechnology
Bachelor of Science Full-time
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