Integrated Bioequivalence Studies
Behind Every Successful Bioequivalence Study: Multiple Areas of Expertise and a Talent for Coordination.
Proving bioequivalence is one key objective of our accelerated First to File service for generic drug companies. But bioequivalence testing itself involves much more than a single step. Cetero orchestrates a turnkey solution in a highly efficient, cost-effective way.
A team of Cetero commercial and scientific staff regularly meets to proactively initiate study designs and bioanalytical assays for certain drugs, in anticipation that generic companies will be pursuing them in the near future.
We begin with protocol and informed consent development, based on a keen understanding of current regulatory requirements both in the US and overseas. We submit the study for IRB/Ethics Committee review, while our clinical teams develop the clinical study execution plan.
Our recruiters quickly line up participants. We select clean, non-smoking participants unless you or the study trial design requires or permits a tobacco-use population. Our more than 1,400 beds ensure readily available accommodation for participants and fast, flexible study start-up.
At Cetero, we are committed to the science and devoted to our client relationships. As a result, we have a proven track record for both high quality results and flexible service. We send study samples for analysis at one of our two bioanalytical laboratories.
Our scientists analyze the majority of samples using methods validated on LC-MS/MS instruments following current Good Laboratory Practices (GLP) and relevant regulatory guidelines. Ligand binding methods are available for large molecules. We offer a comprehensive menu of assays; see our complete list.
Our PK/statistics team is involved in the study from the beginning, to ensure the optimal study design and range required for the bioanalytical assay. Once the recruiting, clinical and bioanalytical specialists have finished, our statistical specialists analyze the data and organize it in an efficient format for submission to regulatory authorities. Should you require interim data analysis, electronic transfer or additional assistance in interpreting the data, we’re always ready to help.
Cetero has performed more than 7,500 bioequivalence studies. We often include them as part of our First to File program, which can take you from first dose to final study reports in as little as 25 days. That’s less than half the normal time – an unprecedented achievement in the industry and a significant advantage in terms of building a successful market for your generic compound. Learn more about First to File.
