- Pharmacokinetic blood samples will be analysed and reviewed before each dose escalation. After the first dose level administration, the dose level and the timing of each blood sample may be adjusted for the subsequent dose escalation. The basis for this decision will depend upon the pharmacokinetic profiles obtained from the preceding group of subjects. All changes will be documented in a file note. The number of samples or volume of blood drawn must not be increased without prior approval of the relevant ethics committee.