Impact of Comorbidity

The pharmacokinetics of the drug is evaluated in the target population fulfilling the criteria for which the indication is sought. The target population may be very wide and include subpopulations suffering from additional diseases affecting the pharmacokinetics of the drugs. These patients might not at all be represented in the trials or in too low numbers, not allowing their altered pharmacokinetic characteristics to be detected. It would be useful to know the kinetics of drugs in a very large number of patho-physiological situations; however, it is clear that this knowledge requires multiple, long, and expensive studies, which cannot all be performed. Examples of therapeutic areas for which the intended population is wide and difficult to fully incorporate in the usual clinical trials are pain medications, antihypertensive drugs, and antibiotics. If important disease-related effects on the pharmacokinetics are detected for a certain patient population, the information should be included in the labeling and, if necessary, appropriate restrictions such as contraindication, warnings, or dose adjustment should be included in the labeling.

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