Date: 18 February, Tuesday
Time: 1 - 1:45 p.m. (Malaysia and Singapore) | 10:30 - 11:15 a.m. (India) | 4 - 4:45 p.m. (Australia)
Presenter: Yin Hoong MOK
Location: Zoom Live Webinar
Registration: Free for JMP users and non-users
Live Webinar
Biosimilar Assessment: A Tiered Testing Approach for Regulatory Approvals
Join us for a webinar on mastering biosimilar assessment, showcasing analytical strategies and tools to meet regulatory standards.
What we cover
Biosimilar assessments focus on critical quality attributes (CQAs) impacting clinical outcomes. The FDA’s tiered approach includes:
- Tier 1: Equivalence testing to establish similarity
- Tier 2: Quality range approach for comparability
- Tier 3: Graphical or raw data representation
Using JMP software, you can:
Perform equivalence testing
- Use JMP’s equivalence or noninferiority tests for precise t-tests or Wilcoxon tests.
- Set variance assumptions, define margins, and customize hypotheses.
Conduct quality range analysis
- Leverage control charts and capability analysis to evaluate metrics.
Create graphical representations
- Create visuals with Graph Builder for Tier 3 assessments.
Key features covered
- Hypothesis selection (equivalence or noninferiority)
- Customizable alpha levels
- Flexible comparison options
Why attend?
Learn to perform robust biosimilarity assessments with JMP tools, ensuring statistical confidence for regulatory submissions.
Don’t miss out! Register now to secure your spot in this free webinar!
Recommended level: Beginner to intermediate