Certificate Course on Bioequivalence Analysis in Drug Development
Conducted by:
SOPHAS in Collaboration with Pumas-AI Inc
Duration:
August – October, 2025
Teaching Methodology:
Flipped Classroom approach
Target Audience:
Professionals involved in pharmaceutical development, research, and regulatory affairs,
including:
o Scientists and researchers from the pharmaceutical industry
o Regulatory affairs professionals
o Statisticians in the pharmaceutical domain
o Academics and students interested in bioequivalence
Objectives
This certificate program offers a practical and comprehensive introduction to bioequivalence analysis in drug development. Participants will learn to design, analyze, and interpret bioequivalence studies using statistical methods while selecting appropriate study designs and approaches for various scenarios. Key skills covered include:
- Statistical inference
- Power and sample size planning
- Data analysis
- Interpreting study results for informed decision-making
Course Structure
Phase 1:
Access to course materials, lectures, and software for self-study and practice.
Duration: August 1-30, 2025 5
Fees:
- Students – ₹6,000
- Academics – ₹7,000
- Industry – ₹20,000
Phase 2:
In-person, five-day workshop at Manipal Academy of Higher Education.
Focus on Pumas software, including PumasCP.
All topics from Phase 1 will be reinforced with a special focus on regulatory guidelines, missing data, statistical methods, and virtual bioequivalence.
Hands-on projects and case studies.
Duration: September 2nd Week, 2025
Phase 3:
Submission of assignments and participation in assessments.
Course completion certificates awarded upon successful completion.
Duration: October 2nd Week, 2025
Topics to be Covered:
Design studies aligning with regulatory guidelines and industry best practices
Perform and interpret statistical inference using various models
Techniques for highly variable drugs and narrow therapeutic index drugs
Skills in power analysis and sample size determination
Use statistical methods and software tools to analyze data
Proficiency with Pumas and PumasCP
Advanced scenarios including virtual bioequivalence and multicenter trials
Understanding of statistical principles and methodologies
Instructors
Yoni Nazarathy
PhD
