Go with the Flow

The average heart can move 6 liters of blood in one minute and 7600 liters (2000 gallons) per day.

Basics of Pharmacokinetics and Toxicokinetics

Pharmacokinetics investigates how a drug affects the body via Absorption, Distribution, Metabolism, and Excretion (ADME). Toxicokinetics is analogous to PK whereby exploring the ADME at doses that can potentially affect toxicity over time, ie. for use in pivotal non-clinical programs.

PK helps determine the optimal dosing regimen, duration of action, and overall pharmacological effect of a drug.
TK helps assess the potential risks associated with exposure to toxic substances and aids in understanding their mechanisms of toxicity.

The dose makes the poison.
In the same vein;
The poison can be medicinal, depending on the dose.

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Blood is a liquid tissue: fluid makes up more than half; plasma, white and red blood cells make up the remainder.

What is non-compartmental analysis (NCA)?

NCA is a method used to evaluate pharmacokinetic and toxicokinetic profiles of a drug. It is a valuable tool for evaluating PK\TK data during all phases of drug development, as it provides a quick and straightforward analysis of the data. It also allows for a comparison of PK or TK profiles between different doses, formulations, or routes of administration. Additionally, NCA can be used to estimate PK parameters for a wide range of drug molecules, including those with complex PK profiles.

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Predictive PK Generation

Pharmacokinetic analysis to support bioanalytical data:
Standard single or multiple dose designs (SAD/MAD), dose proportionality
Bioavailability / Bioequivalence
Drug accumulation
Multiple routes of administration and species
Integration of metabolite(s) profile relative to parent drug

Toxicokinetic analysis to support non-clinical safety and toxicology data:
Full range of studies from Maximum Tolerated Dose (MTD) to pivotal GLP subchronic and chronic studies
Sparse or full bioanalytical data in a variety of biological fluids

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GxP Compliance

- Quick and efficient lead time, saving time and costs
- Analyses are performed in FDA 21 Part 11 GLP/GCP-compliant and validated computerized system, with full QC/QA for reliable, reproducible and accurate results
- Regulatory submission-ready report preparation

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