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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.
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 ...
It deals with the design and development of equipment and processes for the manufacturing of products such as food, feed, pharmaceuticals, nutraceuticals, chemicals, and polymers and paper from biological materials. Bioprocess engineering is a conglomerate of mathematics, biology and industrial design, and consists of various spectrums like ...
To recoup this outlay pharmaceutical companies may do a number of things: [33] 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 bioavailability of those products is limited by their solvation rate. A correlation between the in vivo bioavailability and the in vitro solvation can be found. Class III – low permeability, high solubility . Example: cimetidine; The absorption is limited by the permeation rate but the drug is solvated very fast.
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 ]
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 ...
Such branches of pharmacognosy are still of fundamental importance, particularly for botanical products (widely available as dietary supplements in the U.S. and Canada), quality control purposes, pharmacopoeial protocols and related health regulatory frameworks.