Phase I evaluations
- Study designs and research protocols for pharmacokinetic and bioavailability evaluations in animal models and humans.
- Pharmacokinetic studies for drug metabolites.
- Pharmacokinetic and pharmacodynamic modeling.
- Drug-drug and drug-food interaction study design and implementation.
- Evaluation of results and generation of pharmacokinetic profiles and parameters.
- Generation or review of technical documentation including CSR.
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