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.