SAAMnow Spring 2019 Workshop [Conferences / Workshops]

posted by Helmut Homepage – Vienna, Austria, 2019-03-03 18:24 (1734 d 21:11 ago) – Posting: # 19989
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Dear all,

last year Charlie DiLiberti founded the not-profit organization SAAMnow and provided me the detailed program of the Spring 2019 Workshop

Challenging Statistical Issues with In Vitro and In Vivo Bioequivalence Studies: Extreme Variability, Special Study Designs and Novel Approaches

which will take place April 4/5 in Rockville, MD, USA.

Day 1 – Session 1: Extreme Variability and Aberrant Data in BE Studies

Day 1 – Session 2: In Vitro BE Statistical Issues

Day 2 – Session 3: Practical Issues in BE Statistics

Day 2 – Session 4: Modeling in Bioequivalence

Quoting from his email:

Although we are describing this as a “statistics” workshop, we will be bringing together statisticians and, importantly, the scientists involved in the generation of in vivo and in vitro bioequivalence data. We are hoping that this collaborative, multidisciplinary approach will help to finally break some of the longstanding logjams that have plagued those of us dealing with BE for years, including outliers/aberrant/messy BE data, dealing with zero Cmax and AUC values in data sets, extremely variable drugs (CVs >100%), steady-state BE studies in patients, issues with baseline correction for endogenous drugs, issues with dose-scale (Emax) modeling, and much more. We will have a faculty of well-known speakers, moderators, and panelists, including strong FDA representation.

Sounds extremely interesting!

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Helmut Schütz

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