One critical aspect to successfully introduce a novel pharmaceutical or even
One essential step to introduce a novel pharmaceutical - or even
a generic compound is to establish that the drug as packaged and sold will
to begin selling a generic compound - is to establish that the drug as packaged and sold will
have acceptable safety and efficacy profiles.
have acceptable safety and efficacy profiles.
This is done using clinical trials.
When evaluating these compounds in a clinical trial, both outcomes are possible:
\begin{enumerate}
\item The compound demonstrates sufficient safety and efficacy, and proceeds in the appoval process. \ref{Item:EndSuccess}
\item The compound fails to demonstrate sufficient safety and efficacy, and the approval process halts. \ref{Item:EndFail}
\item The trial is terminated before it can acheive one of the first two outcomes, for reasons unrelated to safety and efficacy concerns. \label{Item:Terminate}