R&D Phase

Formulation and Dissolution profile optimization.

From the pharmaceutical aspect, the similarity factor (f2) could be a good judgment criterion for the similarity between the generic and the brand products, while from the biopharmaceutical point of view it does not guarantee that the product will pass the BE testing.
In Expert Consult, through our highly professional experts, we could help the R&D department during product development to reach the optimum dissolution profile in order to mitigate the risk of bio-failure.
We analyze the DP not only from the pharmaceutical point of view, but also from the biopharmaceutical aspect which does not only rely on the similarity factor f2, but take into consideration the pharmacokinetic parameters and the physicochemical characteristics of the drug molecule as well.
In some cases where the similarity factor is not applicable (e.g, due to high variability), we help the sponsor to apply the most suitable model dependent or model-independent approaches for successful regulatory submission.