One Year On: The Bioequivalence Guidelines

Aug. 25, 2011 - PRLog -- Pharma IQ: First of all, just to put your roles into context, how many bioequivalence studies do you consult on per year? First of all, Helmut, could you take that question?

H Schutz: I would say roughly 30.

A Fuglsang: I think I’m at 15 so far. Most of the studies that I’m consulting on should perhaps be termed therapeutic equivalence studies rather than bioequivalence studies but, yes, 15.

Pharma IQ: Okay, so that’s what we’re working with. I’d like to have a look in more detail at the sort of consultancy that you do and some of your reflections on bioequivalence and the new guidelines that were introduced last year. In your opinion how well have the bioequivalence guidelines been received Helmut?

H Schutz: I think generally very well. People were waiting for these guidelines and there were a lot of discussions and draft guidance, etc, so people in the industry mostly, in my opinion, are really happy that there is something now they can rely on. The section on biowaivers was especially welcomed. This is my impression. I think generally well.

Pharma IQ: Anders, how have you seen the guidelines being received; do you think that there’s good take up across the industry?

A Fuglsang: When we speak about the 2010 guidelines for bioequivalence, yes, I think that people really welcomed that document. That is certainly my impression. We also had, the year before, a guideline on therapeutic equivalence for inhalation products and that’s the type of product I mainly work with. I think a lot of people were very happy when that was published although when they got a bit in to the work the attitude became perhaps it wasn’t all good.

To download the full transcript and mp3 please click here: http://www.bioequivalenceevent.com/Event.aspx?id=532218&u...



Helmut Schutz and Anders Fuglsang will be delivering presentations at the forthcoming 2nd Annual Bioequivalence and Bioavailability Studies Conference, due to take place from 19th -21st September 2011 at the Four Points Sheraton, Brussels, Belgium. For further details please visit www.bioequivalenceevent.com, call 0800 652 2363 or email enquire@iqpc.co.uk.