Pre-Clinical Research Services: An Overview

Pre-clinical research services refers to the arduous testing and the assessment stage which takes place before the clinical trials and after the compound has been identified as being promising. In this stage, the chemical properties of the new drug are assessed and then the desired steps for synthesis and purification are determined. During this research stage, important data is gathered on drug safety, iterative testing and feasibility by evaluating the toxicity and pharmacological effects of the new drug with the help of in vitro and in vivo animal testing.

In order to analyze the effect of the drug in different species, pre-clinical research services typically includes testing of a drug in a rodent as well as non-rodent. In the pre-clinical research services, animal testing generally provides answer to the following four questions

Amount of absorption of the new drug into the bloodr
Breakage of the drug into the bodyr
Toxicity of the new drug and its breakdown productsr
The rate of excretion of the new drug and its breakdown products from the body

Pre-clinical research services offers testing not only on drugs but also on gene therapy solutions, medical devices and so on. Each of these different categories requires different types of pre-clinical research services.

For example: Through testing on animals, drugs undergo pharmacokinetics, pharmacodynamics, Absorption, Distribution, Metabolism, Excretion and toxicity testing. The information and the data collected with the help of these testing enables the researchers to evaluate a starting point of safe drug dosage in order to carry out clinical trials on humans.

These additional tests will not be carried out in the case of medical devices without drug attachment. They will just undergo Good Laboratory Practices (GLP) in order to evaluate the safety of the medical device and its various components. However there are certain medical devices on which biocompatibility testing in order to assess the sustainability of the components of the medical device in a living world. In the case of pre-clinical research services for medical devices, the research is generally carried out on larger species which enables the testing in models that are almost similar in size to that of a human. These can either be pigs, dogs or sheep. However some species are also used for research on the basis of similarity in physiology of organ system. For instance, Goats are used in researches related to mammary implant while dogs are utilized for the studies pertinent to gastric and so on.

On the basis pre-clinical research services, drugs are allocated ‘No Observable Effect Levels (NOEL)’, which helps the researchers in determining safe drug dosage in order to carry out clinical trials on humans.