Drug development is the process of bringing a new drug molecule into clinical practice. In its broadest definition this encompasses all steps from the basic research process of finding a suitable molecular target to supporting the commercial launch of the drug.
Drug discovery is the process through which potential new medicines are identified. It involves a wide range of scientific disciplines, including biology, chemistry and pharmacology. A key goal of drug discovery campaigns is the recognition of new molecular entities that may be of value in the treatment of diseases that qualify as presenting unmet medical needs.
Bioavailability is a key indicator of drug absorption. It represents the administered dose fraction which achieves success in reaching the systemic circulation when administered orally or through any other extravascular dosing route.
Bioequivalence is generally used to establish similarity between a generic drug and reference drug and is defined as the absence of significant differences in the availability of the active ingredient at the site of drug action.
Drug delivery refers to the technology utilized to present the drug to the desired body site for drug release and absorption, or the subsequent transport of the active ingredients across the biological membranes to the site of action.
The drug regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
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