The Problem of Special Populations and Issues of Safety and Efficacy for Drug Registration
It is sensible that therapeutic trials of a new drug should be conducted on patients having the disease(s) concerned, but with as few complicating factors as possible. This is because the first priority must be to discover whether the drug is capable of giving benefit and to do this as quickly and as clearly as is practicable.
KeywordsSpecial Population Data Sheet European Economic Community Positive Duty Creatinine Clearance Rate
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