Application Paper One: New Pharmaceuticals
Before it gets to the shelf, a pharmaceutical has to undergo a sophisticated process that may take several years from the date of discovery of the drug. In the US, for instance, the process is speculated to take an average of 12 years since the time the drug leaves the laboratory to the market. The entire process, however, divides into two primary sections- the pre-clinical and the real clinical activities. The pre-clinical stage mostly comprises of the discovery and the processing of the drug compound. At this juncture, the compounds are known as the new chemical entities. In as much as there would be prospects that the compounds may be useful against a particular disease, most of its aspects like toxicity and metabolism in human beings are still a mystery at this stage (Ciociola et al., 2014). Drug development, therefore, plays the primary role of ascertaining all these parameters before the human clinical tests. Besides, the body will determine the prescriptions of the particular pharmaceutical for the first time use during the test. Similarly, it is at this stage that, with the help of drug development, the chemical composition of the drug is analyzed and determined. Ciociola et al. (2014) collectively refer to these processes as the CMCs of preclinical development or the Chemistry, Manufacturing and Control. On the overall, all the process of drug development at this stage are intent on determining whether the compound entirely satisfies the requirements of the regulatory and licensing bodies. All the information collected at this juncture is then submitted to the FDA, which then takes the pharmaceutical through the clinical phase as an Investigation New Drug (IND).