Bioequivalence studies are designed to show that two drugs are equivalent and substitutable. – But even though the medicines are replaceable, the providers of bioequivalence studies are not.
Digna Tost, Department Manager of Bioanalysis of Small Molecules at Kymos, resumes why Kymos is the right partner for bioequivalence projects:
“Our clients are looking for a CRO that has high quality standards, meets tight timelines and still offers competitive prices. All of that they find with Kymos. At Kymos, we have the highest standards for the quality and regulatory compliance of our bioequivalence projects. All clinical studies are conducted exclusively in reputed European centres. Besides, we and our partners are FDA and EMA inspected and GCP/GLP compliant. Yet, due to decades of experience and good partnerships, we also work quickly and efficiently”.
Kymos offers a one-stop-shop service for bioequivalence studies. From clinical trial management, bioanalysis and pharmacokinetic evaluation to batch testing and, EU release of drugs to be used in the clinical trials. Digna Tost gives an overview of the clinical trial management services Kymos offers for bioequivalence studies:
“In clinical trial management, you get an “all inclusive” package from us. In cooperation with our clinical partners, Kymos provides support from the very first steps of the bioequivalence studies; writing clinical protocols, taking care of submissions to ethics committees and regulatory authorities, as well as the corresponding insurances. Logistically, we coordinate the provision of test and reference products as well as the sample shipment to the bioanalytical facility. We are a GMP certified company with an importer authorisation for marketed medicinal products and IMPs that allows us the importation of reference and test drug products from Non-EU countries in order to conduct clinical trials. In addition, we can offer clinical trial monitoring.”
However, Kymos’ main focus is naturally on the bioanalytical field. Over the past decades, Kymos has succeeded in developing a long list of validated bioanalytical methods in different matrices and with different ranges. With such expertise, we can act quickly and efficiently with minimal costs for our clients. The list of methods including a convenient search function can be found on our service page: Bioequivalence Studies. In addition, we have a significant number of pre-developed methods that we validate for our customers free of charge. For more information, please contact our service managers.
Finally, Digna Tost reveals what makes Kymos special in her eyes:
“In my past experiences in clinical trials, I have always found that stringent clinical management and the highest quality are crucial for a successful bioequivalence study. I am very happy that Kymos prioritises exactly this and that we have so many satisfied customers.”
Digna Tost and the Department of Bioanalysis of Small Molecules