Журнал фармакокинетики и экспериментальной терапии

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From A Regulatory Standpoint, Clinical Pharmacokinetics: Existing Requirements and Future Views

Pravin Shende

The importance of medication pharmacokinetics in determining their safety for human clinical usage is becoming better recognised. Clinical pharmacokinetic data regulatory criteria have developed over time to emphasise and solve these safety concerns. Historically, the dose plans that were commonly prescribed were excessively high, resulting in catastrophic repercussions. As a result, establishing trustworthy dose-response correlations (both therapeutic and harmful) must be a priority. Concurrent advances in our understanding of metabolite pharmacology (therapeutic or toxic), interethnic and interindividual differences in drug responses, and toxicological aspects of drug chirality now provide compelling reasons for bioactivation, pharmacogenetics, and stereochemical factors to be addressed in pharmacokinetic studies during drug development. Capecitabine is one of the fluoro pyrimidine anticancer agents which is extensively used in the management of colorectal cancer. We have noticed a discrepancy between the doses we are using in our patients and the recommended dosing regimen. Thus, this study aims to assess the pharmacokinetic parameters of capecitabine and its metabolites in colorectal cancer patients and report some clinical outcomes.