The determination of an appropriate dose to be administered is partly a medical determination, made by the prescribing physician, and partly the result of scientific testing and development by the manufacturer of the product. Before a drug may be marketed in most countries of the world, the drug and its anticipated effect on the body must be tested, using human subjects. The investigative process is generally referred to as the clinical trial, or the clinical study, of the drug in question
The clinical trial begins with experimental testing that, if successful, will lead to preclinical testing with animals, to assess the effect on live subjects. If the preclinical testing shows sufficient promise, three stages of clinical tests will be conducted: one, to ascertain safe human use; two, the sampling of a broader range of human subjects; and three, to expand the human subject range and to finalize dosages to be recommended.
(Paracetamol is referred to acetaminophen in the US)
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