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Repeated Dose Relative Potency
Studies (continued):
For the reasons discussed
above, studying more than one dose level of one or more
of the treatments being compared makes it more likely that
one can compare side effects of the two treatments at equianalgesic
levels (or vice-versa). In this "explanatory"
approach, one is seeking a precise determination of the
comparative action of the two drugs. However, this may be
unethical in some cases. In the previous example it would
have been difficult or unethical to limit the patient’s
opioid dose, as the standard of care is to titrate the opioid
upwards until the patient feels the optimal tradeoff between
analgesia and side effects has been reached. If the dosage
of all treatments to be compared is limited by side effects,
comparison of the effects at the maximal tolerated doses
may provide the most pragmatic information.
Studies of Broader Patient
Populations Once there is evidence for analgesic efficacy
and optimal dose in one pain model, one may choose to study
the drug in other groups of patients to assess both efficacy
and adverse effects. Analgesic comparators should be those
commonly used in those populations.
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