Posts Tagged ‘clinical research’
Participants in an Early Phase Clinical Research must be healthy, as a healthy human body is critical to the outcome of the effectiveness of the medicine that is being tested.
Therefore, it is important to make sure that the participants of the Early Phase Study are healthy individuals. This allows an accurate baseline to be developed for the efficacy of the drug being tested. Early Phase Studies are designed to gather data on absorption, distribution, metabolization, and elimination from the human body.
Early Phase Studies show how a variety of outcomes, whether it be how long the drug remains in the body, what, if any, the effect drug metabolite by-products may have, the optimal dosage, (where minimum side effects are coupled with maximum therapeutic effect) the step-by-step increases, and what dosage can be safely given. Early Phase Studies are an essential first step in any new drug being marketed by the FDA.
The FDA reviews the Early Phase clinical trial process at several different levels to ensure that the drug is not only effective for the disease, but that it has little to no side effect for the individual in the Early Phase Study. This is why Early Phase Studies are done in different time increments, to allow the clinicians to observe all effects that the drug may cause on the participant of the Early Phase Study.
* Visit www.richmondpharmacology.com for more information about early phase clinical research.
** Take a look at the Clinical Trials website if you are intersted in participating in clinical trials.
*** To Register to take part in Japanese Clinical Trials in London, please visit 治験
*** Remember to always consult your doctor before taking any medical advice.