Is something that’s quite relevant

It has a lot of different steps

And it’s kind of long and complex

Preclinical studies are what happen first

So starting here let’s get immersed

Cell cultures or animals are used to check

If a drug seems safe and has the wanted effect

Then clinical studies, they come next

Four phases take place with human subjects

For Phase I the volunteers are healthy and strong

Twenty to a hundred of them for several months long

About two thirds of drugs make it to the next phase

Because these are the ones that seem to be safe

Phase II involves hundreds of folks with the target condition

Checking for effectiveness is the primary mission

It takes several months to two years to see

And only 45 percent of these drugs move on to Phase III

In Phase III it takes 1 to 4 years to collect data like a detective

Confirming if a drug is both safe and effective

Hundreds to thousands of patients participate

But only five to ten percent of these drugs will graduate

Phase IV begins after a drug hits the market

To post-marketing surveillance we’ve gotta commit

Monitoring for rare adverse events in the population

To protect public health across the nation

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