Special Populations

One of the most widely sought out labeling changes in special populations is that for pediatrics. The application of M&S towards establishing in vivo characteristics as a way to making labeling changes is worth discussing further. The pediatric exclusivity policy is previously described (Sec. 2.3). If there is reasonable belief that the disease process is similar in adults and pediatrics and further an acceptable pharmacological effect marker is available, then studies in pediatrics measuring the concentration-pharmacological effect(s) can be potentially used to recommend dosing changes in pediatrics. The question that is being posed in the pediatric studies is: "Are the pharmacokinetics/pharmacodynamics in pediatrics predictable from those in adults?" Such a question can only be answered by developing concentration-effect relationships. The sponsors are encouraged to employ the model developed based on the PK/PD data in adults to design trials in pediatrics. The analysis of the PK/PD data from trials in pediatrics may require combining data from adults for a more complete understanding of the drug behavior.

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