Bioavailability (BA) and Bioequivalence (BE) studies are regularly conducted as important part in the development of a new formulation of a known pharmaceutical or for the marketing of a generic drug.
Bioavailability is a measurement of the rate and extent to which a therapeutically active substance is absorbed from a drug formulation into the systemic circulation and appears at the site of action.
If two different drugs containing the same therapeutically active substance are bioequivalent, there is no clinically significant difference in their bioavailability.
Developing a generic drug obliges the developer to demonstrate that the newly developed generic drug is bioequivalent to the reference product. How bioequivalence has to be proved is defined in respective guidances of the competent authorities.
For generic drugs, the focus of bioequivalence studies is on the release of the active substance from the tested generic into the systemic circulation and how the resulting systemic exposure profile of the tested generic compares to that of the reference drug.
When planning a bioequivalence study, several factors must be considered in order to complete it successfully: appropriate study design, sampling schedule, desired release characteristics, and any confounding by endogenous compounds – these are just some of the topics which are vital for a successful generic drug development program.
CRS experts have remarkable experience regarding generic drug development. And at CRS we appreciate the opportunity to help guide your program towards approval.
Generic drugs play a significant role in modern healthcare by providing safe, effective, and lower-cost alternatives to their equivalent marketed drugs. Thus, the market for generic drugs has grown substantially over the last years and is expected to continue to do so.
The rapid growth of and the rising competition in the generic market have placed significant pressure on generic drug developers to gain first to market designation for their generic medication.
CRS fully understands this rush. And CRS experts are accustomed to meet this and work within urgent timelines and strict budgets. At CRS we will manage your study with expertise and toughness, as we have successfully managed a variety of bioequivalence studies across many therapeutic areas.
At CRS we understand our customers’ challenges and can surely help to manage your clinical trial with our expertise and experience.
Just contact our CRS experts about how to effectively design and execute your next bioequivalence study.
CRS has many years of experience in studies on pharmacokinetic and bioequivalence. Upon request, a CRS team of experienced professionals will provide a complete program for such studies on healthy volunteers or on a population with special health conditions.
CRS provides high-quality data from bioequivalence studies conducted by highly trained staff. And of course, all studies are performed strictly in accordance to good clinical practices (GCP).
CRS-owned Clinical Units have been operating since 2006. They have successfully completed more than 1000 bioequivalence and biosimilar trials supporting marketing authorization.
Thus, CRS Clinical Research Services is the leading clinical research organization (CRO) to conduct and support your bioavailability and bioequivalence studies.