One Year On: The Bioequivalence Guidelines                Interview by Helen Winsor, Pharma IQ      Helmut Schutz of BEBAC...
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One Year On: The Bioequivalence Guidelines

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Helmut Schutz of BEBAC Consultancy and Anders Fuglsang of Fuglsang Pharma Consultancy, join Pharma IQ to discuss the impact of the bioequivalence guidelines introduced in summer 2010 on the pharmaceutical industry.

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One Year On: The Bioequivalence Guidelines

  1. 1. One Year On: The Bioequivalence Guidelines Interview by Helen Winsor, Pharma IQ Helmut Schutz of BEBAC Consultancy and Anders Fuglsang of Fuglsang Pharma Consultancy, join Pharma IQ to discuss the impact of the bioequivalence guidelines introduced in summer 2010 on the pharmaceutical industry.Pharma IQ: First of all, just to put your roles into context, how many bioequivalence studiesdo 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 perhapsbe 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 atthe sort of consultancy that you do and some of your reflections on bioequivalence and thenew guidelines that were introduced last year. In your opinion how well have thebioequivalence guidelines been received Helmut?H Schutz: I think generally very well. People were waiting for these guidelines and there werea lot of discussions and draft guidance, etc, so people in the industry mostly, in my opinion,are really happy that there is something now they can rely on.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 wasespecially welcomed. This is my impression. I think generally well.Pharma IQ: Anders, how have you seen the guidelines being received; do you think thatthere’s good take up across the industry?A Fuglsang: When we speak about the 2010 guidelines for bioequivalence, yes, I think thatpeople really welcomed that document. That is certainly my impression. We also had, theyear before, a guideline on therapeutic equivalence for inhalation products and that’s the typeof product I mainly work with. I think a lot of people were very happy when that was publishedalthough 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://bit.ly/mULr4aHelmut Schutz and Anders Fuglsang will be delivering presentations at the forthcoming 2ndAnnual Bioequivalence and Bioavailability Studies Conference, due to take place from 19th-21st September 2011 at the Four Points Sheraton, Brussels, Belgium. For further detailsplease visit www.bioequibalenceevent.com, call 0800 652 2363 or email enquire@iqpc.co.uk. 1
  2. 2. IQPCPlease note that we do all we can to ensure accuracy within the translation to word of audio interviews but that errors may stillunderstandably occur in some cases. If you believe that a serious inaccuracy has been made within the text, please contact +44(0) 207 368 9425 or email helen.winsor@iqpc.co.uk. 2

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