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jag009 ★★★ NJ, 2012-05-18 23:05 (5136 d 06:11 ago) Posting: # 8586 Views: 4,454 |
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Hi everyone, Does anyone know if FDA has a guidance on overage of a drug product? Example, OROS drug products have overage. Is there a limit as to how much overage is allowed? Thanks John |
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Helmut ★★★   Vienna, Austria, 2012-05-19 04:02 (5136 d 01:14 ago) @ jag009 Posting: # 8588 Views: 3,688 |
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Hi John! ❝ Does anyone know if FDA has a guidance on overage of a drug product? None I'm aware of. ❝ Example, OROS drug products have overage. Didn’t know that! The NDA of Concerta (01/2000) states in the first label: Each extended release tablet for once-a-day oral administration contains 18 or 36 mg of methylphenidate HCl USP […] In the Clinical Pharmacology Biopharmaceutics Reviews we read:The OROS® system delivers 18 or 36 mg of methylphenidate HCl […] So my first idea was that – by design – not the entire dose is released. 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.  ❝ Is there a limit as to how much overage is allowed? No idea. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2012-05-21 17:19 (5133 d 11:57 ago) @ Helmut Posting: # 8595 Views: 3,443 |
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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. 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 |
Ing. Helmut Schütz