The materials of the professional presentations delivered by leading biosimilar research experts at the 4th Annual Biosimilars Forum are available to download as a courtesy of the event series. Don't miss out, this exclusive offer is available only for a couple of weeks!
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Inside you will find all the presentation materials delivered during the 4th Biosimilars Forum by subject matter experts from the fields of regulatory, academic and clinical research (17-18 OCT, 2019).
These lectures provide essential information for research management, leadership and support teams working in and for biosimilar drug development:
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Professional short course (111 pages)
Robust methods for assessment of average and scaled average bioequivalence
Theoretical considerations (13 pages)
Balaam’s Design Revisited
Theoretical considerations (17 pages)
Measuring switchability using observational data
Theoretical considerations (31 pages)
Applications of the expected power (statistical assurance) for bioequivalence trials
Regulatory Questions - Keynote (18 pages)
Current challenges in the development of biosimilars
Regulatory Questions (32 pages)
Quality and statistics: bringing two worlds together
Regulatory Questions (20 pages)
Regulatory reflections on biosimilar development and statistical methods used at quality level
Regulatory Questions (18 pages)
Is similarity different? – Recent developments from the regulatory perspective
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