Certificate Course on Bioequivalence Analysis
in Drug Development
Conducted by
SOPHAS in Collaboration with Pumas-AI Inc
Duration
3 months (August to October 2025)
Teaching Methodology
Flipped Classroom approach
Target Audience
This program is designed for professionals involved in pharmaceutical development, research, and regulatory affairs, including:
● Scientists and researchers in the pharmaceutical industry
● Regulatory affairs professionals
● Statisticians working in the pharmaceutical domain
● Academics and students interested in bioequivalence
Objectives:
This certificate program offers a practical and comprehensive introduction to bioequivalence (BE) analysis in drug development. Designed for professionals and students in pharmaceutical sciences, clinical research, and biostatistics, the course provides hands-on experience with real-world tools and methods essential for modern bioequivalence studies.
Participants will learn to:
- Design, analyze, and interpret bioequivalence studies using statistical methods
- Select appropriate study designs tailored to both regulatory and developmental scenarios
- Make informed decisions based on accurate interpretation of BE data
- Reason about the suitability and assumptions of statistical approaches to bioequivalence.
- Use state of the art software tools including Pumas and PumasCP, in view of classical SAS procedures that are sometimes specified in guidelines.
Key skills covered include:
- Statistical inference
- Power and sample size planning
- Data analysis
- Interpreting study results for informed decision-making
- Comprehend FDA guidelines and product specific guidelines.
- Have knowledge about bioequivalence methodology research.
Course Structure
Phase 1:
Structured Virtual Learning
Duration: 1 month (1 Aug to 31 Aug 2025)
Format: Online, self-paced with guided materials
A structured virtual module designed to build strong theoretical foundations in bioequivalence analysis.
Participants will receive:
- Access to recorded lectures, curated reading materials, and licensed software tools for self-paced learning
- Assignments and problem sets designed to test and reinforce key concepts
- Exercises to prepare for more advanced hands-on work in the next phase
This phase ensures that learners are equipped with the essential background knowledge and tools before moving into application-based project work.
Phase 2:
In-Person Project-Based Learning
Duration: 5 days (1st Week of Sep 2025)
Location: PSG IMSR, Coimbatore
An immersive, five-days in-person workshop that blends theory with hands-on, project-based learning experience.
This phase includes:
- A capstone project simulating a real-world bioequivalence analysis along with case studies
- A special module on virtual bioequivalence, focusing on innovative trial simulation approaches
- In-depth training sessions with Pumas and PumasCP, industry-standard software for pharmacometrics modeling and simulation
- Expert-led sessions to reinforce Phase 1 topics with a special focus on regulatory guidelines, handling missing data, and advanced statistical methods
This intensive workshop equips learners with the confidence and capability to conduct and critically evaluate bioequivalence studies in professional settings.
Phase 3:
Submission and Certification
Duration: 1 month (Dates TBD)
Final Submission: 2nd Week of Oct 2025
In the final phase of the program, learners will complete their learning journey through project submissions and final assessments.
This phase concludes the program, recognizing participants based on their engagement and performance:
Based on participation and performance, participants will be awarded one of the following:
- Certificate of Attendance: For those who complete the virtual learning and attend the in-person workshop.
- Certificate of Completion: For those who submit the capstone project and meet performance criteria.
These certificates formally acknowledge the participant’s proficiency in leveraging artificial intelligence techniques to advance drug development processes and make data-driven decisions.
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
Expert Statistical Consultant, Pumas-AI Inc.
Vijay Ivaturi, PhD
Co-Founder & CEO, Pumas-AI Inc. Endowed Chair, Center for Pharmacometrics, Manipal
Fee Structure
|
Category
|
Full Course Fee
|
|---|---|
|
Students
|
₹6,000
|
|
Academics
|
₹7,000
|
|
Industry
|
₹20,000
|
Registration Form
Call for Sponsors: Support the Future of Bioequivalence Research
We are pleased to invite sponsorship for the upcoming three-months hybrid certificate program in Bioequivalence Analysis in Drug Development. This initiative brings together early-career researchers, professionals, and students from across the country to build essential, hands-on expertise in a critical area of generic drug development.
Sponsorship contributions will be directed toward supporting travel and accommodation for course participants attending the in-person workshop (Phase 2) at PSG IMSR, Coimbatore, ensuring broader access and inclusion.
Sponsor Benefits
In recognition of your support, sponsors will receive prominent visibility across all phases of the course through:
- Inclusion of sponsor logos on all official course communications—both digital and print (brochures, certificates, presentation decks, etc.)
- Dedicated shoutouts and acknowledgments on our social media platforms
- On-site recognition during the in-person workshop through banners, displays, and verbal mentions
- Optional engagement opportunities, such as addressing participants or distributing branded materials during the event
We believe that your partnership will not only help foster the next generation of scientific talent but also highlights your organization’s commitment to education and innovation in drug development.
For sponsorship inquiries and customized partnership options, please contact us at connect@sophas.net