Bioequivalence and Bioavailability Forum

Hi everyone,

I was recently involved in some discussions about BE training and the topic of IVIVCs came up. I also came across a publication from last year by a bunch of USFDA reviewers about applying IVIVCs in generic drug development. Based on my rather limited experience, despite the benefits that an IVIVC brings, many generic companies either don't do them for their oral extended-release products or don't do them correctly. As many of you have direct working experience either with or within generic drug companies, could you perhaps share why you think this is the case? If it's such an uphill climb, is there any point in trying to sell IVIVCs to the generic drug companies?

Looking forward to hearing your views