Strategies for Optimising Your Bioequivalence Studies



Pharma IQ
06/26/2010


Pharma IQ caught up with Dr. Ole Østerberg, Clinical Research Scientist at NeuroSearch, ahead of the Bioequivalence and Bioavailability conference, taking place in Munich on the 26th-27th of October, where Dr. Østerberg will be speaking on “Implementing Effective Modelling and Simulation Tools to Establish Bioequivalence”.

What impact do you think the new EMA guidelines have had on investigation of bioequivalence and bioanalysis?


I think they have had a huge impact. Obviously, when you as a pharmaceutical company conduct BE and BA trials, it is to get regulatory approval. So whatever the regulatory bodies say in their guidelines, we will follow very carefully.

What are the advantages of optimising in vitro studies?


You should conduct as many in vitro studies, as to make you comfortable enough to conduct in vivo studies in humans. In vitro studies can say a lot, depending of course on the compound’s specific physical and chemical properties. Say if you wanted to do bioequivalence for a sustained release product, then you could in vitro have some dissolution methods set up. From that you could see how the drug is released from the formulation. You could optimise that in vitro, then take the optimal formulation and put that in vivo.

In vivo studies in humans are expensive and time-consuming, so you want to have as few failures as possible. What you do see sometimes are surprises in vivo, when things don’t fit, or something like that, then you have to go back in vitro. At some point you could take 2 or 3 formulations that you have in an in vitro profile to in vivo, first make an initial study and select the most optimal one to go forward with.

What tips would you give for choosing the right simulation and modelling tools?


What you could do is consult the guidelines again, and have a look at how they would go about this. You could also at various papers. When choosing a tool, scientists should chose a tool that they have the best knowledge of to use, so not necessarily the most user friendly tool, but the tool that the specific scientist has the best opportunity or experience in using.

If you were planning on outsourcing, what would be your top tips for finding the right bioanalytical service provider?


Well my first tip would be, to look less at the price tag on the provider, and more on the quality you would receive. If there were to be any issues regarding your bioanalytical services, authorities might question, and you could end up with a failed trial that you have to repeat. So, number one look at the quality not at the price tag.

Experience is also a very important factor. Often you will see new or emerging service providers. What you have to do is reassure yourself, that they have experienced people behind any cost estimate for an analytical solution.

For anyone interested in attending the event, what will be the key take home message of your presentation?


What I am going to show is that, you can certainly use modelling and simulation to optimise your PK profile. Initially, although you may think you have an optimal profile, you should try to look further, and as soon as possible, optimise your formulation prior to phase II and phase III trials with the compound.