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As the name suggest, Pre-clinical Development/Research is before starting the clinical research/trials. The safety testing of a drug which is conducted in vitro (in the test tube or laboratory) and in vivo (in animals), which must occur before a drug can be tested on humans, is known as Preclinical Research (Prior to Clinical-Research).

All the Clinical research should follow the FDA's rules and regulations. As per the FDA requirements for research in clinical trials, a sponsor must first submit data before any kind of clinical trials, showing that the drug is reasonably safe for use in initial, small-scale clinical studies/research.

The sponsor(conductor of clinical research) may have several options for fulfilling this requirement depending on whether the compound has been studied or marketed previously,
(1) The Sponser can compile existing nonclinical data from past in vitro laboratory or animal studies on the compound;
(2) The Sponser can compile data from previous clinical testing/research or marketing of the drug in the United States or another country whose population is relevant to the U.S. population; or
(3) The Sponser can undertake new preclinical studies(or preclinical research) designed to provide the evidence necessary to support the safety of administering the compound to humans.

At the preclinical stage, the FDA will generally ask, at a minimum, that sponsors:
(1) develop a pharmacological profile of the drug;
(2) determine the acute toxicity of the drug in at least two species of animals, and
(3) conduct short-term toxicity studies ranging from 2 weeks to 3 months, depending on the proposed duration of use of the substance in the proposed clinical research studies.

Preclinical research can answer the following questions:
How much of the compound is likely to be absorbed?
Where is it likely to work?
Is it likely to reach the target cells/tissues?
How much is it likely to be changed by organs, such as the liver, kidneys, skin or lungs?
What harmful chemicals and break-down products is it likely to produce?
Will it do more harm than good?
Could it potentially cause cancer or harm an unborn child, for example?
How quickly will it be cleared from the body?
Will it stay in the body long enough to do its job, but without causing other problems in the process?

If it becomes clear that the compound is potentially unsafe or unlikely to work, no further tests will be done and it will not be developed further. This way preclinical trial is actual pre-requisite for actual start of clinical research (
Four Phases of Clinical Research).