Preclinical trials, also known as non-clinical trials are the laboratory tests of a new drug, device or medical treatment on animal subjects. The main aim of preclinical studies is to see whether the drug or the treatment really works and whether it is safe to test on humans.
Thus, the main goal of a preclinical research is to collect sufficient data and establish the safety profile of the drug or the treatment under question. And to fulfill this objective, various types of studies are carried out in a preclinical trial.
Here we enlist these types of studies and their significance in a preclinical studies:
It’s a simple and rapidly performed initial screening test to determine the presence or absence of a particular pharmacodynamic activity in the new drug. E.g. determination of analgesic or pain relieving activity in the new drug.
2.Tests on isolated organs and bacterial cultures
These are few preliminary tests to determine specific activity in the new drug like anti-histaminic, anti-bacterial, anti-secretory, vasodilatation etc. Healthy organs isolated from dead animals or bacterial cultures are used for these preliminary tests.
3.Tests on animal models
Animal models like rat, pig, mouse, hamster, and rabbit are used to determine the actual effects of the drug in a live organism. After successful results in initial stages, higher animals like cats, dogs, and monkeys are used for preclinical trials.
4.General observational test
The drug under the trial is injected in tripling doses to a small group of mice which are then observed for any hidden effects.
5.Confirmatory tests and analogous activities
Compounds which yield a desirable result are carried forward in the trial for more complex tests. Other activities like antipyretic and anti-inflammatory are further determined for an elaborate examination of the drug properties.
6.Mechanism of action
Experiments are conducted to determine the mechanism of the action of the drug. E.g. if the drug is an anti-hypertensive drug, whether it is an alpha or beta blocker, ACE inhibitor or calcium channel blocker.
Besides determination of the action of the drug, its effects on individual and major organ systems like nervous, cardio-vascular, respiratory, and renal are also examined. This can give a clue about any possible side-effects of the drug on any major organ system.
It includes examination of the dose-response relationship, maximal effects, and comparative efficacy of the new drug with the existing drug, thus establishing the market value of the drug.
It involves the study of the movement of the drug substance in the body of the living organism which includes the processes of absorption, distribution, metabolism, localization in tissues, and excretion from the body. They help to know the safe dose and preferred route of administration for the drug.
Both short-term or acute and long-term or chronic toxicity testing are carried out to determine the toxic effects of the drug and mortality in animal models.
All these tests are carried out under a standard procedure of “Good Laboratory Practice” to safeguard the quality, integrity, and safety of the preclinical trials.
Preclinical research services at Cognibrain supports to identify the therapeutic efficacy of bio-molecules, synthetic molecules, nutraceuticals and plant extracts using effective and results oriented preclinical models.