Pharmacokinetics (PK) assay for Preclinical Research

Pharmacokinetics (PK) in rodents is the quantitative study of the time course of drug disposition. It describes the fate of a xenobiotic compound within a living organism. This involves determining the concentration of the drug in systemic circulation and at its site of action over a given period, providing a foundation for understanding the relationship between drug dose, exposure, and effect.
At Vibiosphen, we provide robust Pharmacokinetics models in rodents to support the development of novel antibiotics, antifungals, and antivirals. Our models are designed to generate clinically relevant data that help pharmaceutical, and biotechnology companies accelerate drug discovery and vaccine research.
 

Background of Pharmacokinetics (PK) assay

Pharmacokinetics (PK) is often summarized by the acronym ADME:
•    Absorption: How the drug enters the body and reaches the bloodstream from its site of administration (e.g., oral, intravenous).
•    Distribution: How the drug travels from the bloodstream to different tissues and organs in the body.
•    Metabolism: How the body chemically changes the drug, typically making it easier to excrete.
•    Excretion: How the body eliminates the drug and its metabolites from the system (e.g., urine, feces, bile).
While not perfect, rodents share many metabolic pathways with humans, making them a useful model for predicting how a drug might be processed in a human body.
The data collected from rodent PK studies are used to predict human equivalent doses, inform the design of later-stage efficacy and safety studies, and guide the selection of a suitable drug candidate for further development.

Rodent Models of Pharmacokinetics assay

Mouse lineages

•    The primary mouse lineages used in preclinical studies are inbred strains known for their genetic uniformity, which minimizes experimental variability.

    C57BL/6 mice have a T-helper type 1 (Th1) biased immune response, which is a cellular immune response important for fighting intracellular pathogens and cancer.
    BALB/c mice have a T-helper type 2 (Th2) biased immune response. A Th2 response is a humoral immune response that relies on antibodies and is essential for combatting extracellular parasites.

•    Outbred mice, unlike their inbred counterparts, are maintained in large, randomly bred colonies to maximize genetic variation. This heterogeneity makes each mouse genetically unique.
    CD-1/OF1 (also known as ICR) mice
    Swiss mice
The decision to use an inbred or outbred strain depends on the specific research question. Inbred mice are for when you want to minimize all genetic variables and pinpoint the effect of a single factor. Outbred mice are for when you want to see how a factor affects a genetically varied population.

Rat lineages

•    Inbred strain, meaning they are genetically uniform, and provide a consistent baseline for preclinical studies, which is essential for reproducibility.
    Fischer 344 (F344) rats

•    Outbred rats. They have a wide range of genetic variability, which better represents the genetic diversity found in the human population 
    Sprague Dawley rats 
    Wistar rats

The decision to use an inbred or outbred strain depends on the specific research question. Inbred rats are for when you want to minimize all genetic variables and pinpoint the effect of a single factor. Outbred rats are for when you want to see how a factor affects a genetically varied population.

Routes of Administration

Compounds under evaluation can be administered through several routes to reflect clinical usage and pharmacological profiles:
•    Oral gavage 
•    Intraperitoneal route
•    Intravenous route
•    Subcutaneous route
•    Intramuscular route
•    Intranasal route
•    Inhalation / aerosolization route
•    Intratracheal route
 

Readouts in Pharmacokinetics Models

A study design can vary in complexity, from simple to sophisticated, because the choice of design depends on the specific research question being asked and the stage of drug development.

Blood, urine and organs (liver, kidney, lung, spleen, stomach, intestine, bladder, heart…) can be sampled at different time points.
Advanced analytical techniques like Liquid Chromatography-Mass Spectrometry (LC-MS/MS) are used to identify and quantify the drug's metabolites in various samples.

This provides insight into its distribution.

Why Choose Vibiosphen?

•    Proven expertise in preclinical research
•    Flexible and customized study designs adapted to sponsor requirements (see downloads available as example) 
•    Advanced facilities to ensure reliable and reproducible results (BSL2 and BSL3) 
•    Strong collaborations with pharmaceutical companies, biotech firms, and academic partners
Vibiosphen combines scientific excellence with industry know-how to deliver actionable preclinical data that drive innovation in infectious disease therapeutics.
 

Contact Us

If you are developing new treatments or vaccines, Vibiosphen can help accelerate your research.
Contact us today to discuss your project and explore how our Pharmacokinetics models can support your development strategy. 
We will be pleased to facilitate your project by providing a customized study design to your project objectives.