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This overview addresses go or
no go decision making with
particular emphasis on
the fundamental rationale
and key criteria behind go
or no go decision making
in pharmaceutical
research and development,
including how safety, efficacy,
and pharmacokinetics
are evaluated
throughout pre clinical
and clinical stages.
We will discuss
structured approaches
such as risk benefit analysis,
expert interpretation,
and portfolio management
in guiding these
crucial decisions.
The importance of
managing uncertainty,
leveraging data
driven frameworks,
and aligning decisions with
corporate strategy will
also be highlighted.
Ultimately, we aim
to illustrate how
these principles help
optimize resources,
prioritize promising assets,
and promote patient safety.
Go or no go decision making is
central to pharmaceutical
research and development,
shaping the fate
of new molecules
from discovery to
regulatory approval.
These pivotal
decisions determine
whether a candidate advances,
aiming to optimize resources and
maximize clinical and
commercial success.
The key criteria,
safety, efficacy,
and pharmacokinetics
are evaluated alongside
risk benefit analysis and
portfolio management frameworks.
This disciplined data
driven approach helps
navigate early
stage uncertainties
in the development process.
In the pre clinical phase,
go or no go decisions depend on
a candidate's safety
in animal models,
early efficacy in
relevant essays,
and pharmacokinetic
features like
bioavailability and half life.
