Pharmaceutical Microbiology and Biotechnology

Drug Discovery and Development

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In the areas of medicine, biotechnology and pharmacology, drug discovery is the process by which new drug candidates are discovered. Historically, drugs have been discovered by identifying the active ingredient from traditional remedies or by fortuitous discovery. Subsequent chemical libraries of small synthetic molecules, natural products or extracts have been screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as conventional pharmacology. Since the sequencing of the human genome has allowed for the rapid cloning and synthesis of large amounts of purified proteins, it has become common to use high throughput screening of large compound libraries against isolated biological targets that are assumed to be a modification Of the disease in a process known as reverse pharmacology. The results of these screens are then tested in cells and then in animals for efficacy.

Drug development is the process of introducing a new pharmaceutical drug to the market once a lead compound has been identified by the drug discovery process. It includes pre-clinical research on micro-organisms and animals, the filing of regulatory status, such as through the US Food and Drug Administration for a new experimental drug to launch clinical trials on Humans and may include the step of getting regulatory approval with a new Drug to market the drug.