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The Importance of Pharmacokinetics Testing Before Beginning Clinical Trials

Researchers and pharmaceuticals in the midst of designing a stronger pre-clinical study will need to understand the ways pharmacokinetics testing can play a role in their trials. Pharmacokinetics is a science that studies how certain substances affect a living organism when administered.

This particular science determines what happens to a drug from the time it is administered throughout its circulation within the body and to the moment when it is ultimately eliminated from the body. The fate of  any drug may change based on the site of administration, formulation and dosage.

There are several different models that are used to understand the concepts of pharmacokinetics testing along with the processes that take place. The multi-compartment model is a commonly used mathematical standard and illustrates how certain materials or energies move throughout a system.

Four years ago, the European Medicines Agency released a guideline discussing safety issues within pharmacology studies. The brief discussed the importance of ensuring medications are safe to use in humans by analyzing the drug’s effects on cardiovascular, central nervous, and respiratory systems in animal models first.

The guideline recommends researchers to conduct in vivo testing along with standard toxicity studies to ensure their drug development efforts are safe and to reduce animal use within pre-clinical trials. These tests determine the overall effects of the medication when compared to its desired therapeutic target. Safety pharmacology studies can also be included in future clinical drug development.

There are specific studies that need to be conducted before researchers move forward with human clinical trials. These include in vitro metabolic and plasma protein binding trials on animals as well as systemic exposure data in repeated-dose toxicity studies.

Some of the most important pharmacokinetic properties to understand during pre-clinical testing include distribution, absorption, metabolism, and excretion. All species and in vitro biochemical data regarding drug reactions will need to be reported and analyzed before proceeding with human clinical trials.

Afterward, animal metabolites data can be compared to the statistics of human metabolites and then it can be determined whether further testing is necessary. Additionally, the EMA brief explains that for drugs with an administration dose of less than 10 milligrams, it may be necessary to test a greater amount of the drug material to learn of any adverse reactions.

Acute toxicity studies are also important to conduct, but lethality should not be the expected endpoint for such tests, according to the EMA guidelines. Pharmacokinetic testing can ensure that drugs do not fail during clinical trials for reasons that could have been predicted and avoided.

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Categories: Toxicology and Pharmacology

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