Early Clinical Development Plan
Completion requirements
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3. Importance of Pharmacokinetics (PK) and Pharmacodynamics (PD)
- Pharmacokinetics (PK) study what the body does to the medicine. This means they:
- Determine the plasma time-concentrations (active substance, metabolites).
- Establish the exposures that have an effect in vivo (Latin for ‘in the living’).
- Allow systematic exposure in order to assess toxicology
- Pharmacodynamics (PD) study what the medicine does to the body. This means they:
- Provide measures of on-target medicine effect and duration of effect.
- Assay depends on mechanism of action.
PK and PD influence how the dose is selected and they help schedule how it is used.