Pharmacokinetics
Naïve, protein-naïve and non-naïve study subjects with potential distinct genetic, clinical and immunological phenotypes.
Enzyme(s) induction and drug-drug interaction studies.
Standard, non-standard and surgical routes of administration (oral, intravenous, subcutaneous, spinal, parenteral, intracerebral, cisternal, ocular, gastric tract)
Pre-formulated liquid or solid dosage forms.
Dose formulation for liquid forms (sterile or non-sterile) with sample retention for analysis.
Tissue-specific drug levels by biosampling, biopsy or microdialysis (cerebrospinal fluid, liver, muscle, skin).
Acute, short-infusion or repeated dosing using experimental or latin-square study designs.
Standard and extended-time tissue samples collection for small molecules and biologics with or without recovery phase.
Standard, dose escalation and dose tolerability drug exposure levels.
Drug disposition assessment using metabolic sampling, including bile secretion.