Bioequivance Studies and Its Implications The best way to define Bioequivalence is that it's 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 under similar conditions in an appropriately designed study.”
Though bioequivalence is mostly discussed in association to generic medicines, it is crucial to note that bioequivalence studies are conducted for innovator medicine as well in certain situations such as:
● When there are changes in formulation have taken place post an innovative product has been sanctioned, for instance a change in any one or more inactive ingredient ●
Between the formulations that are used in clinical trials and the product to be marketed for any new medicine
Bioequivalence studies are a substitute for clinical accuracy and safety data as it would not be generally practical to replicate clinical studies for generic products. It is a known fact that if a plasma concentration of the active ingredient of the innovator and generic medicines remain the same, then their concentration at the action site is going to remain the same. Hence, in addition to being bioequivalent, a generic medicine must affirm to the high quality standards with regards to the manufacturing method and the purity of the final pharmaceutical form.
Examining bioequivalence in a normal population
The moment an innovator medicine is developed, there is a need for evidence of its pharmacokinetic properties, safety and efficacy in healthy volunteers and the target patient population. Usually bioequivalence only performed in healthy volunteers in order to minimize the variability not related to differences between products. This increases the probability for the question as to whether the generic medicine would perform differently in a target patient population, taking into account factors such as comorbidities, concurrent prescriptions and physiological factors that comprises differences in first pass metabolism, gastric pH and bacterial flora.
Today eminent clinical research organizations (CROâ€™s) conduct numerous studies on bioequivalence in a strict compliance with global regulatory requirements. These studies are carefully managed by an independent and able quality assurance department. Furthermore, these CROâ€™s have also constituted a dedicated team which is competent enough to validate and develop a minimum of five methods for bioequivalence studies. Furthermore, these studies address numerous formulations comprising solid oral formulations i.e. IR, ER, MR and tablets and liquid oral formulation like suspensions and syrups.
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