Bioequivalence Study Design for Generic Drugs

Overcoming the Nuances of BE Studies in Cancer Therapies

Designing and managing a bioequivalence (BE) study using healthy volunteers is a relatively straightforward process.

BE studies in cancer patients, though, present a unique set of challenges, including the understanding of how to find and motivate investigators; convincing patients to engage in extended treatments; collecting, processing and analyzing samples; and proper documentation for site training and drug and sample shipments.

If you’re considering a BE study in oncology, Medelis can design your plan to overcome the typical challenges of managing an oncology BE study.

We understand the challenges of investigator selection, the investigator/patient relationship, documentation and laboratory procedures, and coordinating vendor activities to ensure that sites have the needed materials to dose patients and process the samples.

Value to Sponsors

Our deep oncology CRO experience, along with our experience in designing and overseeing BE studies, provides you with:

  • An understanding of how to enroll investigators and patients in a bioequivalence study
  • A set of standard procedures for the lab, including processes for sample collection, storage, shipment and analysis
  • Recommendations for documentation
  • Advice on how to handle trade-offs for patients, to encourage participation

Understanding these nuances, before you enroll your first patient, enables you to avoid the multitude of issues that can extend your timelines and increase the cost of your BE study.

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