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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