ABSTRACT
Introduction I was sitting in my office one day minding my own business (i.e.,
staring out the window) when I received a call from one of our clinical research scientists. I refer to it as resting one’s eyes - staring out the window, that is. After staring at statistical outputs of a computer screen all day, it is good to dwell on distance for just a moment or two - if for no other reason than to keep your eyes from going bad. If anyone gives you a hard time about it, hand them a stack of sta-
tistical outputs needing sorting out, review, and interpretation, and ask them to come back to you in two to three hours if they still really have a problem with it. They will not likely come back, and it is possible you will never see them again. The scientist had received a message from one of our company’s offices
in the Far East (South Korea), requesting assistance with a statistical issue. It related to one of our key drug projects and was, to paraphrase, ‘How does one go about statistically analysing pharmacokinetic data? We just did a study and do not know what to do with the data.’ I was tempted to tell her I did not know either (and to call someone
else), but I knew I could not get away with that.... It was my drug project; I did know how to analyse pharmacokinetic data; and even if I referred her to someone else in the company, eventually the question would make its way back to me. I was the one with the Western pharmacokinetic data to which they would wish (even though they did not know it yet) to compare these new data. I must admit I was tempted, though. What started off as a seeming annoyance, turned into a very inter-
esting project as we began looking at the data that had been generated in South Korea, and we will discuss the statistical assessment of population pharmacokinetics at some length in this chapter. This information is generally used in the label of new drug products to ensure they are used safely and effectively in different populations. Some aspects also may impact regulatory approval of drugs.
