Bioequivalence and Bioavailability Forum • FDA regulation on Overage of drug product

FDA regulation on Overage of drug product [Regulatives / Guidelines]

posted by jag009 – NJ, 2012-05-21 17:19 (5133 d 14:39 ago) – Posting: # 8595
Views: 3,443

Hi Helmut,

❝ But in three studies (18 mg, fasting and fed) retrieved capsules were analysed for drug content, which was <1.2%.

❝ So: how much overage have you measured? We have just finished a study with 36 mg; I’ll have a look into the CoAs. :-D

That's the million dollar question ;-)

We are looking into that now...

The hypothetical question I have is:

Generic fails to show BE to an OROS delivery tablet because the Cmax and AUC ratios were too high. Analysis on OROS tablets "Shells" recovered from subjects' fecal samples (Yuck! The clinic staff love me!) indicates significant residual drugs in a few subjects (lets say 8/30 subjects). If one corrects the bio data based on this finding (ie: adjust the results for those subjects), would regulatory agency be okay if the study turns out to be BE based on the adjustment?

Have you heard about a person (Don't know the gender) who had several OROS tablet shells stuck in her large interestine because of his diverticulitis condition?

Thanks

John

Complete thread:

FDA regulation on Overage of drug product jag009 2012-05-18 21:05 [Regulatives / Guidelines]
- FDA regulation on Overage of drug product Helmut 2012-05-19 02:02
  - FDA regulation on Overage of drug productjag009 2012-05-21 15:19