2. INTRODUCTION
• Toxicokinetics is defined by The International Conference on Harmonization (ICH)
as the generation of pharmacokinetic data, either as an integral component in the
conduct of non-clinical toxicity studies.
• Toxicokinetics is the quantitation of the time course of toxicant in the body during
the process of ADME.
• It describes how the body handles a toxicant, as a function of dose and time, in
terms of ADME
3. CONT.
• Absorption, the rate of chemical absorption from the site of application into the
blood stream.
• The rate and extent of chemical movement out of blood into the tissue is
distribution.
• The rate and extent of chemical biotransformation into metabolites is called
metabolism.
• The rate of chemical removal from the body is called excretion.
4. IMPORTANCE
• Generation of kinetic data for systemic exposure and toxicity assessment of the
drugs.
• Check, If the safety ratio is balanced or safety is more then it will be used as good
therapeutic agent.
• Important in drug development, especially in preclinical stage.
• Tk evaluation is useful for the setting safe dose level in clinical phases, selection of
dose, form, alternative dosing route, evaluation of toxicological mechanism, and for
setting safe dose level in clinical phase.
• To reduce the animal used.
5. CONT.
• TK data practically used for the purpose of drug discovery such as lead-optimization
and candidate selection.
• Used to set safe dose for clinical use of new drugs.
• Useful in understanding the differences in responses or sensitivity between
individual animals, genders, species, and life stages.
6. APPLICATION
• Screening of anticancer drugs.
• Cell based bioassay.
• To determine the cytotoxicity.
• In vitro screening of several drugs.
• Production of antiviral vaccines.
• Cancer research, which require the study of uncontrolled cell division in culture.
• Cell fusion technique.
• Molecular biology and biotechnology.