Please wait while the transcript is being prepared...
0:00
This overview addresses Drug Development,
with particular emphasis on
the key stages of drug development,
starting from initial discovery and
preclinical testing through
human clinical trials
and regulatory approval.
We will discuss the roles
of regulatory agencies,
the challenges and high
failure rates inherent in
the process, and the importance of
designing safe and effective formulations.
Finally, we’ll highlight how
post-marketing surveillance and
ongoing innovation ensure
continued patient safety
and access to new therapies..
Drug development is a
complex process turning
scientific discoveries into
safe, effective medicines.
It begins with discovery, where
thousands of compounds are
screened using genomics,
molecular modeling, and
high-throughput methods.
Of up to ten thousand initial compounds,
only a few proceed to
preclinical research, where
lab and animal studies assess toxicity,
pharmacokinetics, and biological effects.
These preclinical models aim
to predict human responses, but
species differences pose challenges.
Good laboratory practice (GLP)
ensures reliable data
before human testing.
After preclinical safety is shown,
drug candidates advance to
human clinical trials in
Phases one through four.
In Phase one, small groups of healthy
volunteers—or sometimes patients—receive the drug to assess safety,
metabolism, pharmacokinetics,
maximum tolerated dose, and
initial pharmacodynamics.
Phase two explores the
drug in patients with
the target condition,
focusing on efficacy,
