Drug development is time consuming and costly which contains preclinical , clinical and after-market. In principle, if all the processes are straight-forward, a drug can be developed in a seven year period. In practice, drug development takes in excess of twelve years. Procedures are tightly regulated both for safety and to ensure drugs are effective. Of the many compounds studied with the potential to become a medicine, most are eliminated during the initial research phases. Clinical trials follow extensive research using in vitro and animal studies. Even so, many drugs are withdrawn or fail, never becoming approved as medicines. Common reasons include side-effects, the drug proving less effective than hoped or lacking financial viability. Overview of Development Process Drug Discovery Screening Pre-Clinical Testing IND Application Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials New Drug Application (NDA) / Biologics License Appli...
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