Evaluation
Types of Studies
The assessment of the BE of two medicinal products is based on the fundamental assumption that two medicinal products are equivalent when the rate and extent of absorption of the test product does not differ significantly from that of the reference medicinal product when the two medicinal products are taken simultaneously.
BE studies are generally recommended using the following endpoints, listed in order of preference:
- Pharmacokinetic studies
- Pharmacodynamic studies
- Significant Clinical Trials
- In vitro dissolution studies
Introduction
Bioequivalence
The absence of significant differences in the bioavailability of the active component at the medicine's action is characterized as bioequivalence, which is widely used to determine similarity between a generic pharmaceutical product and the reference drug.
The plasma concentration-time curve is commonly used in BE studies to determine the pace and degree of absorption. The area under the concentration-time curve, or AUC, represents the degree of exposure. The absorption rate influences Cmax, the highest concentration or peak plasma exposure, and tmax, the time to peak plasma concentration.
Comparison products
for Bioequivalence studies
Pre-marketing research and post-marketing monitoring plans extensively examined and documented the quality, safety, and efficacy of the unique product, which was granted marketing authorization for the first time. As a result, the innovative product is the most appropriate comparison for establishing interchangeability. Indeed, if a new product is available, a generic pharmaceutical product should not be utilized as a comparative. The risk of utilizing a generic pharmaceutical product as a comparator rather than the innovative product is that no assurance can be given that future multi-source products are bioequivalent to the novel product, leading in a lack of interchangeability with the innovative product.
Prototype - innovative pharmaceutical products are approved by international and local organisations (FDA - EMA - EOF) that are responsible for evaluating their quality, safety and efficacy.
To be more precise, before the product is put on the market, the assessment authorities evaluate the research that the pharmaceutical businesses presented to them. Then, the authorization is given.
Generic products must submit studies to the evaluation authorities to show their bioequivalence with the original drugs in order to receive marketing authorization. In the bioequivalence research, only the original products may be used as a comparator.
