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This talk introduces statistics
in drug development,
using it as a basis for
further exploration of
the essential role of statistics
throughout drug development,
from discovery to regulatory
approval and clinical use.
We will examine how
statistical thinking
informs experimental design,
manages biological
variability, and
supports evidence based
decisions in clinical trials.
The lecture will highlight
frameworks and methods that
statisticians use to guide
study interpretation,
regulatory assessment, and
the adoption of new innovations.
Finally, we will discuss
the growing importance of
statistical literacy and
discipline amid the
increasing complexity
of modern drug development.
Statistics is integral
to drug development
from early discovery to
regulatory approval and beyond.
Statistical reasoning
supports robust
experimental design,
sound interpretation, and
reliable decision making.
This lecture explores
a medicine's journey
from laboratory to clinical use,
highlighting how
statistical thinking
navigates scientific,
medical, and regulatory
complexities.
It addresses biological
variability,
informs decisions
under uncertainty,
shapes trial analysis, and
guides conclusions accepted
by regulators and clinicians.
Drug discovery starts with
numerous chemical or
biological candidates
screened for safety
and effectiveness.
Statistical methods design
high throughput screens,
quantify assay variability,
and prioritize hits.
These tools distinguish
real signals from noise,
