Is it not necessary to conduct studies in mixed population if the drug is meant for both male and female?
CHP – Good question. The answer is “Yes”. It makes sense to be required to test a drug on the intended population – all of the intended population. This is the reason given for testing medications in children if this is the intended population. You would not want to take a medication that has not been tested on your peers so why would you want your child to be given a medication that has not been tested on children the same age.
