Spring Intro 2023

16/02/2023

Important terminology

“Superiority” • Treatment A is better than Treatment B

“Non-inferiority” • Treatment A is no worse than Treatment B

“Interim analysis” • Mid-trial analysis of data available at that time • Objective is to facilitate decisions about the future of the trial

The Organisation for Professionals in Regulatory Affairs

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Single rising / ascending dose = SRD / SAD Multiple rising / ascending dose = MRD / MAD

Rising ascending dose studies

• Typical cohort size = 8 subjects

• Often 6 on active drug plus 2 on placebo

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Cohort 8

The Organisation for Professionals in Regulatory Affairs

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