BIOINFORMATICS

Drug Discovery process is an expensive and time consuming process that may be succeed or may not. Retrospective analysis of pharmaceutical industry during the 1990’s estimate that each new drug in the market takes an average 12-15 years to develop, costing in the region of $1.3 billion. In addition, one in nine compounds that enters clinical trials makes it to the market.

In the present era, the emerging new diseases are very much responsible for the advancement in the field of Computer Aided Drug Design (CADD). Drug Designing is the innovative boom in the field of Bioinformatics which is very cost and time effective. Hence, computers are playing a vital role in the Drug Designing.

Drug Discovery process have formed by four factors ; Scientific Knowledge, Available Technology, Human Resources and Diseases. The Scientific Knowledge, Available Technology, Human Resource provide the strategic assets by which the strategies were formed.

A pharmaceutical company conducts laboratory and animal studies to show biological activity of the compound against the target disease, and the compound is evaluated for safety.

II. INVESTIGATIONAL NEW DRUG APPLICATION (IND):

After completing preclinical testing, a company files an IND with the U.S. Food and Drug Administration (FDA) to begin to test the drug in people. The IND becomes effective if FDA does not disapprove it within 30days. The IND shows results of previous experiments; how, where and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in the animal studies; and how the compound is manufactured. All clinical trials must be reviewed and approved by the Institutional Review Board (IRB) where the trials will be conducted.

III. CLINICAL TRIALS:

In this studies are primarily concerned with assessing the drug candidate’s safety. A small number of healthy volunteers are given the compound to test what happens to the drug in the human body – how it is absorbed, metabolized and excreted. About 70% of drug candidates pass this initial phase of testing.

The drug candidate is tested for efficacy. Usually, this is explored in a randomised trial where the compound or a drug is given to several hundred patients with the condition or disease to be treated. Depending on the condition the trial can last from several months to several number of years. The output is an increased understanding of the safety of the compound and clear information about effectiveness. If a drug passes this phase, then it can be considered that the drug can be considered truly a drug.

A drug is tested in several hundred to several thousand patients. This provides a more through understanding of the drug’s effectiveness, benefits and the range of possible adverse reactions. These trials typically last several years.

Once FDA approves an NDA, the new medicine becomes available for physicians to prescribe. A company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality control records.

Hence, in this way a drug is said to be passed through different trials and atlast to the market.