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Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source.
In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of ...
The United States Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose ...
Carefully research the demand for their potential new product before spending an outlay of company funds. [33] Obtain a patent on the new medicine preventing other companies from producing that medicine for a certain allocation of time. [33] The inverse benefit law describes the relationship between a drugs therapeutic benefits and its marketing.
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals [1] [2] classified as high-cost, [3] [4] [5] high complexity and/or high touch. [4] Specialty drugs are often biologics [ 3 ] [ 6 ] —"drugs derived from living cells" [ 7 ] that are injectable or infused (although some are oral medications). [ 4 ]
Berberine, a plant compound traditionally used in herbal medicine, is today commonly stocked on the shelves of health food stores and pharmacies as a supplement.. Berberine supplements gained ...
Biotechnology is the research and development in the laboratory using bioinformatics for exploration, extraction, exploitation, and production from any living organisms and any source of biomass by means of biochemical engineering where high value-added products could be planned (reproduced by biosynthesis, for example), forecasted, formulated ...
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form .