The Effective Statistician - in association with PSI

What is the ASAP and what you should know about it

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Interview with Greg Ball
  • The US FDA has been advocating for aggregate program-level safety evaluations since 1988 when the ISS was introduced (the IND Safety Reporting Final Rule).
  • Aggregate data analysis looks at all available data holistically rather than relying on individual case reports. This allows for a more complete understanding of potential risks associated with a drug or vaccine.
  • In the near future, more companies will adopt a systematic approach to aggregate safety assessment planning and IND safety reporting.
  • This process will develop a better understanding of the safety profile of drugs and ensure that patients' safety is well-thought-of.
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    The Effective Statistician - in association with PSIBy Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry
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