




BA/BE
BA/BE – decades of experience that matter
SocraTec R&D represents decades of experience in bioavailability and bioequivalence studies. This means that we have experience in all aspects of relevance for a successful BA/BE trial:
- “Probability of success” estimation based on in-vitro investigations
- Authorities’ approval requirements worldwide
- Optimised standardisation of administration conditions
- A huge diversity of administration routes and dosage forms
- Highly variable drugs
- Clinical performance in healthy subjects and patients – both mono- and multi-centric
- Adequate sequential designs and pilot studies
- Measures to improve inspection safety in all steps of the trial
BA/BE – practical experience that helps
We have conducted hundreds of bioavailability and bioequivalence studies by ourselves. These trials enjoy high acceptance by authorities, a fact which ultimately reduces your timelines and brings your product faster to the market.
BA/BE – expert evaluation
We have a lot of experience with expert evaluation of BA/BE studies in dossiers of products intended to be in-licensed. Our highly experienced scientists contribute all their experience to identify potential pitfalls as well as promising candidates.
BE trials are often conducted in other countries
… But often this is not the most profitable solution:
- For BE trials a mechanistic cookbook approach is often unsuccessful.
- Adequate source data verification often entails great efforts by the sponsor and is difficult to perform …
- … but absolutely necessary to avoid GCP findings and other unpleasant surprises.
… but sometimes this is the solution needed for strategic or medical reasons. In such cases our experience is very helpful. From design development to protocol writing, on-site training and monitoring up to evaluation and reporting – our experts help you to conduct your trial also in countries other than Germany.