The webinar will provide a general introduction to the topic of combining sexes for statistical analysis in Toxicology. For electrocardiography and .. Read more jacketed external telemetry data, it will discuss scientific preferences, historical data review and statistical recommendations. For Developmental and Reproductive Toxicology endpoints, it will focus on neurobehavioral data. However, these tests are conducted at various stages in development so a statistical plan that accounts for potential sex differences, whilst still allowing for the additional power that may be observed from pooling the sexes is required. PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date. In this Webinar focus will be given to safety biomarkers.
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