Pharmacokinetics is the science that studies how an administered substance affects a living organism in relation to the substance’s absorption, distribution and metabolism. This can help researchers and pharmaceuticals formulate better products by understanding the amount of a substance required for various effects.
Pharmacokinetics is the study of what happens to a drug when it is administered versus while it’s circulating in the body, and how these processes may change when taking a drug orally, via injection or transdermally.
Pharmacokinetics testing is an important aspect of understanding the way your drug or supplement works during its life cycle. The process could involve changing models over time to give a more accurate representation of the ways in which substances move inside the body, initiate multiple chemical reactions at once and how they interact with other compounds. As such, it is important to test different models to understand what happens when a drug is administered.
The European Medicines Agency’s (EMA) guideline on pharmacokinetic testing for drugs used in the treatment of patients with cardiovascular disease has become an important document for those working in this field. The EMA summarises its expectations for safety assessment by stating that studies should begin with pharmacodynamic analyses and follow up with pharmacokinetic ones.
The guideline recommends researchers conduct pharmacokinetic 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 effects of a medication on the body at various stages, such as absorption and elimination over time. Safety pharmacology studies can also be included in future clinical drug development.
Pre-clinical testing required for drug approval is conducted to ensure that the drug is safe for human use. These studies measure the pharmacokinetics of a compound in the body. This includes distribution, absorption, metabolism and excretion. Species and in vitro biochemical data regarding drug reactions will need to be reported and analysed before proceeding with human clinical trials.
Pre-clinical and clinical pharmacokinetic testing is integral to understanding how a drug will be delivered to the tissues in the body. Characterization of pharmacokinetic properties allows us to optimise delivery methods, determine appropriate doses, and ultimately help ensure safety in certain patient populations. Understanding these properties before clinical trials can help you ensure patients receive an optimal dose of medication and are not at risk for overdosing by accident or design.
The pharmacokinetic testing will take up to two weeks and can be carried out with certain drugs only when they are not being used. The animal metabolites data can then be compared with that of human metabolites and it could determine if further testing on the drug is necessary.
In addition to that, pharmacokinetic testing is important to conduct before clinical trials in order to ensure that drugs do not fail during these studies. If a pharmacokinetic test shows that after a certain dosage level, a drug does not show the desired results, this can be taken into consideration for adjusting any necessary dosage levels during follow-up clinical trials.
Acute tox study are currently used to determine the safety of new drug candidates, but these tests should not be used as an endpoint when assessing a chemical’s fate. Based on a review of the available data, pharmacokinetic testing can ensure that drugs do not fail during clinical trials for reasons that could have been predicted and avoided.