Pharmacokinetics

Naïve, protein-naïve and non-naïve study subjects with potential distinct genetic, clinical and immunological phenotypes.

Standard, non-standard and surgical routes of administration (oral, intravenous, subcutaneous, spinal, parenteral, intracerebral, cisternal, ocular, gastric tract)

Dose formulation for liquid forms (sterile or non-sterile) with sample retention for analysis.

Acute, short-infusion or repeated dosing using experimental or latin-square study designs.

Standard, dose escalation and dose tolerability drug exposure levels.

Enzyme(s) induction and drug-drug interaction studies.

Pre-formulated liquid or solid dosage forms.

Tissue-specific drug levels by biosampling, biopsy or microdialysis (cerebrospinal fluid, liver, muscle, skin).

Standard and extended-time tissue samples collection for small molecules and biologics with or without recovery phase.

Drug disposition assessment using metabolic sampling, including bile secretion.

Information
Assess the oral bioavailability, exposure level and half-life of the test compound

Protocol
The test compound is administered acutely orally (intragastric; one dose) and intravenously (one dose) at two diferent times (cross-over design) or in two sets of primates (experimental design). Blood is collected at different time-points over the course of 24 hours after administration. The level of test compound is quantified in the samples.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, bioanalysis is conducted and a full report generated.

Information
Assess the systemic availability, exposure level and half-life of the test protein

Protocol
The test compound is administered acutely subcutaneously or intravenously (one dose; bolus or infusion). Blood is collected at different time-points over the course of multiple days.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, bioanalysis is conducted and a full report generated.

Information
Assess the dose-depency of the systemic availability, exposure level and half-life of the test protein or compound

Protocol
The test compound or protein is administered acutely at different dose levels at different times (cross-over design) or in different sets of primates (experimental design). Blood is collected at different time-points after administration based of the nature of the test material. The level of test compound is quantified in the samples.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, bioanalysis is conducted and a full report generated.

Information
Assess drug tolerance during dose-escalation pharmacokinetic

Protocol
The adverse effects of drug exposure are evaluated using clinical chemistry, clinical pathology and clinical toxicology. General adverse effects are evaluated using clinical assessments (neurologic and behavioral).

Delivery
Clinical laboratory profile and/or clinical assessments reports.

Information
Assess the systemic availability, exposure level and half-life of the test protein or compound after multiple administration

Protocol
The test compound or protein is administered repeatedly at the same or different intervals. Blood is collected at different time-points after administration based of the nature of the test material. The level of test compound is quantified in the samples.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, bioanalysis is conducted and a full report generated.

Information
Assess tissue drug level during standard or non-standard pharmacokinetic

Protocol
The drug levels are measured in specific tissues and fluids by biopsies or microdialysis during the conduct of a standard or specialized pharmacokinetic study.

Delivery
Tissue samples or tissue extracts are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, bioanalysis is conducted and a full report generated.

Information
Assess the effect of repeated compound exposure on liver enzymes.

Protocol
The test compound is administered repeatedely at the same or different intervals. Blood is collected at different time-points over the course of 24 hours after administration on the first day and last day of the study. The level of test compound is quantified in the samples. The two pharmacokinetic profiles are compared to assess effects on liver enzymes.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, bioanalysis is conducted and a full report generated.

Information
Assess enzyme and transporter-mediated drug-drug interactions

Protocol
A probe substrate cocktail is co-administrated with the test compound to simultaneously evaluate impact on multiple clinically relevant enzymes and transporters. Alternatively, specific inhibitors are used to identify metabolic pathways during standard pharmacokinetic.

Delivery
Substrate cocktail kinetic profile with/without the test compound. Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for test compound bioanalysis (DAS: dose-and-ship). Alternatively, bioanalysis is conducted and a full report generated.

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