Special Populations and Evidence of Safety and Efficacy for Drug Registration
Every patient presents individual characterisitics, and the dosage of a drug has to be adapted according to the pharmacokinetics and pharmacodynamics in that patient. It is therefore somewhat misleading to talk about dosage requirements in the “average adult”. From a practical point of view it is however necessary to define such an average dosage requirement. Still, one has to be aware that the dosage has to be adapted according to the characteristics of the individual patient and to the response to the starting dose.
KeywordsSpecial Population Special Group Drug Application Package Insert Average Adult
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