Preclinical studies and clinical studies can be differentiated by a simple classification of the subjects used during studies. Testing is done before drug components are deemed safe for testing in humans fall under the preclinical study category.
This means preclinical studies are conducted mostly in other organisms. Preclinical drug development plays a crucial role in drug discovery and development as the data generated here is further used in clinical studies.
What Is The Basic Goal Of Preclinical Studies?
The preclinical trial comprises testing processes that indicate drug safety for use in humans. This considers many parameters like the dosage of the drug, efficacy for each dose, iterative study, and drug feasibility.
This is a very rigorous process of drug development as around one in fifty thousand drug component is finally approved in preclinical studies for further research in the clinical phase. In this form of initial trials, drugs are mostly tested for safety. The safety profile of a chosen component is assessed in subjects through these processes.
It will be wrong to assume that the preclinical trial only comprises of drug testing. These studies are also carried out for medical devices, gene therapy solutions, and multiple other therapeutic tools.
Such tools skip the pharmacodynamics and pharmacokinetics processes and are sent forward to check for good laboratory practices. This happens only when a drug is not associated with these tools.
Types Of Preclinical Studies
Depending on the drug component, there can be various forms of concepts used in preclinical studies. Here we will look at a few processes that are commonly used in preclinical drug development studies.
- Pharmacodynamics
This is a phase of preclinical CRO process to study how the drug affects an organism’s body. This concept surrounds the complex areas of biochemical and physiological effects a drug component has on the body.
It lays great emphasis on the dose-response data, which helps to figure out how an animal or some other organism used as a testing subject responds to different doses of the same drug component. This concept also looks into drug-receptor interactions and lays the path for further research in drug development.
- Pharmacokinetics
This is a follow-up concept in pharmacology which revolves around the reaction the body has to drug components. It comprises of some fundamental studies that generate data on absorption, distribution, metabolism, and excretion of drug components.
This reflects on how the body absorbs a new drug component, the pathway for best absorption, if and how it is distributed and metabolized. The excretion part looks into whether or not the body can excrete out the remaining component, unused parts, et cetera.
- Toxicology
This is the most critical part of drug safety. Toxicology studies focus on finding adverse effects of drug components and lay the ground rules for safe usage. It also looks into how the body can efficiently eliminate the toxins that it produces under the influence of a drug.
Studies in preclinical CRO make use of these basic concepts at all times in case of generic and brand name version drug development.
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