ICH M13A-Bioequivalence for Immediate-Release Solid Oral Dosage Forms

Wishlist Share
Share Course
Page Link
Share On Social Media

About Course

Focuses on latest bioequivalence (BE) requirements from ICH, 

EMA, USFDA, & SFDA perspectives highlighting on: 

ICH Guideline M13A that came into effect in Jan 2025 in Europe 

Newly added/revised FDA Product-Specific Guidances’ (PSGs) Impacted by M13A by Feb 2026. 

USFDA Data Integrity & Handling & Retention of Testing Samples 2024

What Will You Learn?

  • Understand the updated BE requirements according to ICH M13A for the Study design, conduct including reference & strength selection & study evaluation
  • Ability to implement the study report, identify & compile the data needed to be submitted
  • Recognize requirements for handling & retention of testing samples in BE studies
  • Interpret criticality of Data Integrity in BE studies
  • Ability to recognize when BE is required in variation (post approval changes)

Course Content

Module 1 – Study Design

  • Module 1
    58:32

Module 2 – Subjects & Selection of Products

Module 3 – Study Conduct

Module 4 – Fating versus Fed studies & Characteristics to be investigated

Module 5 – Study Evaluation

Module 6 – In vitro dissolution & Data Integrity

Module 7 – Retention of Testing Samples & Variation application

Final quiz

Earn a certificate

Add this certificate to your resume to demonstrate your skills & increase your chances of getting noticed.

selected template

Student Ratings & Reviews

No Review Yet
No Review Yet

Notify Me When Live

Hiring Notification