Bioequivalence Center Activities

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  • Wednesday, 10 January 2018 10:52

MSA University -  Bioequivalence Center Activities
 

1. Bioequivalence and Bio-weivar study:

- Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.

- A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent.

- MSA bioequivalence center have all facilities and equipment required to undergo steps of Biowaiver and Bioequivalence study

2. Analytical Research:

- Research Service support and enhance the research, education, and public service missions of the University by providing access to characterization and process instrumentation.

- Staff provides the assistance and guidance necessary so that students, faculty, and industry get the most effective and appropriate use of the center's facilities.

3. Fromualition:

 Is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product.

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