ABSTRACT

Nobody would nowadays contemplate taking a new drug into clinical trials without some preclinical PK information — as a minimum, data on plasma halflife, clearance, and volume of distribution in rats. The value of such information is undisputed: we need to know what plasma concentration to expect (and this can often be related to in vitro efficacy data), how long this concentration will be sustained after a single dose, and what dose was required to achieve it.