ABSTRACT
The PK/TK analysis is an essential part of assessing drug safety in the course of drug discovery and development through preclinical investigations, clinical trials and the post-marketing surveillance of a new drug entity. The preclinical TK analysis is associated with the quantitative toxicity assessment of a new synthetic compound immediately after the initial phase of discovery. The analysis provides information and guidance in planning to optimize the dose and dosing regimen for human. The merged notion of PK/TK analysis is clearly dened and expressed in the ICH guidelines S3A as “… the generation of pharmacokinetic data, either as an integral component of the conduct of non-clinical toxicity studies or in specialty designed supportive studies, in order to assess systemic exposure.”
