- Pharmacokinetic studies: Metabolism and kinetics of drugs in target species
- Bioavailability and bioequivalence studies
- Dose confirmation studies: pharmacokinetic-pharmacodynamic relationship: pK/pD reports
- MIC Studies: assessment of the risk of generating antimicrobial resistance
- Tolerance studies in the target species (EMEA/CVMP/VICH/393388/2006)
- Clinical efficacy studies: experimental and field studies
- Follow-up studies of adverse reaction reports: Pharmacovigilance
- Expert Report
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