ABSTRACT
Clinical pharmacokinetics are studied in detail, and pharma cokinetic analysis may be non-compartmental or compartmental, based on mathematical modelling. The primary aim of these studies is to determine the maximum tolerated dose (MTD) and the dose recommended for Phase II studies. This is achieved by means of dose escalations, which are determined through observed toxicities and pharmacokinetic analysis and pharma codynamic studies relating drug toxicity to drug exposure (AUC). Phase I studies usually involve patients who have failed on previous treatment regimes, and usually small numbers of patients are treated at each dose level, the total number of patients involved in the trial tending to be around 30 on average. Patients are selected on the basis of strict eligibility criteria.
