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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
While some studies have found that vitamin D 3 raises 25(OH)D blood levels faster and remains active in the body longer, [44] [45] others contend that vitamin D 2 sources are equally bioavailable and effective for raising and sustaining 25(OH)D. [46] [47] If digestive disorders compromise absorption, then intramuscular injection of up to ...
Vitamin D (the inactive version) is mainly from two forms: vitamin D 3 and vitamin D 2. Vitamin D 3, or cholecalciferol, is formed in the skin after exposure to sunlight or ultra violet radiation or from D 3 supplements or fortified food sources. Vitamin D 2, or ergocalciferol, is obtained from D 2 supplements or fortified food sources. [3]
With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
Ergocalciferol, also known as vitamin D 2 and nonspecifically calciferol, is a type of vitamin D found in food. It is used as a dietary supplement [ 3 ] to prevent and treat vitamin D deficiency [ 4 ] due to poor absorption by the intestines or liver disease . [ 5 ]
Cholecalciferol is a form of vitamin D which is naturally synthesized in skin and functions as a pro-hormone, being converted to calcitriol. This is important for maintaining calcium levels and promoting bone health and development. [4] As a medication, cholecalciferol may be taken as a dietary supplement to prevent or to treat vitamin D ...
[8] [9] Fungi are grown industrially to enable ergosterol extraction and preparation as a powder for sale as a vitamin D 2 dietary supplement and food additive. [10] Preparations of irradiated ergosterol containing a mixture of previtamin and vitamin D 2 were called viosterol in the 1930s. [11]
1α-Hydroxyvitamin D 5 is a chemical derivative of vitamin D 5.The motive to study 1α-hydroxyvitamin D 5 as a potential pharmaceutical drug stemmed from the tendency of calcitriol, a natural metabolite produced in the kidney, to cause toxic hypercalcemia in patients when dosed at concentrations needed to interrupt prostate cancer cells' cycle and stimulate apoptosis.