COURSES IN
Bioequivalence
Bioequivalence Course – Concepts, Issues, and Pitfalls
Our bioequivalence course is designed to help you understand and apply the fundamental concepts of this critical field. It provides a comprehensive approach to the basics of bioequivalence and the potential challenges, with a special focus on its application in the pharmaceutical industry. Ideal for R&D professionals, the course aims to enhance your understanding of bioequivalence testing and its essential role in drug development. Through expertly guided lessons, you’ll learn to conduct bioequivalence studies accurately and analyze results, using real-life examples and relevant software tools.
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Tečaj Bioekvivalencije
Bioequivalence course organization:
- For groups
- Online or live (at the CAIR Center or at the client’s location – for groups)
- Duration: 4 days for 4 hours/day
- It is possible to enroll in a course that is followed exclusively through ready-made videos with subsequent consultations
Additional information
- Participants will learn to correctly set the null and alternative statistical hypothesis of bio-equivalence (BE), become familiar with standard methods for bio-equivalence testing (in-vitro and in-vivo, in accordance with the current guidelines of regulatory agencies (FDA, EMEA)), they will learn to understand and interpret the results of typical statistical BE reports, and become familiar with various approaches/methods that can reduce the risk of study failure. They will also learn to evaluate different designs, and to estimate sample size and test power for individual designs.
- For courses held online, recordings of lectures are available for those participants who are unable to attend all lectures. Recordings and materials are available to participants for the entire duration of the course and one month after its completion.
- In agreement with the participants, it is possible to include the data of the participants in the course program.
- After passing the knowledge test, we issue a certificate of course attendance.