Clinical Trials Translation

Clinical trial of pharmaceutical agents is the necessary step required for development of any new drug or for expansion of indications for application of already known drugs. In the initial stages of drug development chemical, physical, biological, microbiological, pharmacology, toxicology and other studies are conducted in tissues (in vitro) or in laboratory animals. These are so called preclinical (non-clinical) studies, which are intended to establish and evaluate (using the scientific methods) the efficacy and safety of experimental drugs. However, such studies could not provide reliable information on how the drug will act in humans, since the animal organisms differ from human organisms in both pharmacokinetic characteristics and in body organs and systems response to drug exposure. Therefore, it is necessary to perform clinical trials of drugs in humans.

 

Clinical trials and clinical researches for new drugs, medical devices and other biotechnology products are increasingly being conducted in other countries, by specialized contract research organizations (CROs). The need for timely, accurate translation in this industry has grown exponentially.

 

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