PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment

  • Dates: 15 – 15 Oct, 2019
2:00pm to 3:30pm

Speakers: 

  • Thomas Lang (EMA BSWP / AGES)
  • Johanna Mielke (Bayer)
  • Bruno Boulanger (Pharmalex)

This webinar will discuss statistical requirements for the assessment of analytical comparability and similarity assessments, for example between biosimilars and reference products or before and after manufacturing changes. This topic has been the subject of a recent EMA reflection paper and an EFSPI working group. New strategies are proposed as an alternative to mean comparisons and include the assessment of ranges, inferential approaches or the use of Bayesian methods.

This webinar is free to attend, to register please click here.


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