We are pleased to announce a new format and series to add to our 505(b)(2) Blog: a video blog / podcast called What Went Wrong?
For our first episode, Ken Phelps, CEO, and Dr. Ruth Stevens, CSO, Camargo Pharmaceutical Services, discuss important considerations for studies outside the United States.
To watch, press play below.
Ken Phelps, President & CEO, and Ruth Stevens, PhD, MBA, CSO of Camargo Pharmaceutical Services
Episode 1: Important Considerations for Studies Outside the United States
Welcome to a series of podcasts that are going to talk about what can go wrong in drug development and how can you avoid these things from happening in the first place if you do things right.
So for the first episode today, Ruth, we’re going to talk about what happens when an international client is doing studies outside the United States and what can go wrong when they choose the comparator product?
The first thing we do when we have an international client coming to the US to get a product approved is we really look at the listed drug that they use to compare or bridge their safety and efficacy data.
Many times the trials have been completed. That’s why we want to look. Have they started the bridging study? If not, we have a chance to get in and have the correct listed drug incorporated into the study design.
If they have already conducted a number of phase 1 studies and they have used a listed drug either from their country where they have sourced that listed drug, it has to be redone. As far as the US drug development program, it is very important to start with the right sourced listed drug.
In order to get approval in the US, the comparator drug has to demonstrate that the country of origin is the exact same as what the people in the US get and that’s an extremely difficult endeavor.
Let me follow up on why it’s important. You would think that the two would be the same. Often times they are not. There are different excipients used which would affect bioavailability. That’s what the FDA is looking at. They’re looking at the manufacturing processes, which would impact bioavailability. Is it the same? And if it’s different, you have to explain those differences and support them.
Right. In summary, it is important to get the right comparator drug.
Are you interested in learning more about what studies may be used for your development program? Camargo can help. Contact us to learn more.