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Toxicokinetics in preclinical evaluation.
1Consultancy and Regulatory Services, Covance Laboratories, Harrogate, UK. paul.baldrick@covance.com
Drug Discovery Today
|February 6, 2003
Summary
Toxicokinetics, the study of drug absorption and metabolism, is crucial for drug development. Understanding toxicokinetic data helps link drug exposure to toxicity and informs clinical safety assessments.
Area of Science:
- Pharmacology
- Drug Development
- Toxicology
Background:
- Toxicokinetic evaluation is a regulatory and scientific necessity in drug development.
- The term "toxicokinetics" is relatively new and its precise application is often misunderstood within the pharmaceutical industry.
Purpose of the Study:
- To clarify the definition and role of toxicokinetics in drug development.
- To explain how toxicokinetic data aids in understanding the relationship between drug dosage and observed toxicity.
- To highlight the importance of toxicokinetics in clinical settings for establishing safety parameters.
Main Methods:
- Toxicokinetics involves generating kinetic data to evaluate systemic exposure.
- Data is collected either as part of preclinical toxicity studies or in dedicated supportive investigations.
Main Results:
- Toxicokinetic data are essential for correlating toxicity with administered doses.
- These data assist in determining safe plasma concentration limits for initial human trials.
- Toxicokinetic information is vital for calculating safety margins during drug development.
Conclusions:
- Toxicokinetics is indispensable for assessing systemic exposure and its relationship to toxicity.
- Accurate toxicokinetic evaluation supports informed decision-making throughout the drug development lifecycle, from preclinical to clinical phases.