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

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

posted by Helmut – Vienna, Austria, 2012-05-19 04:02 (5136 d 22:36 ago) – Posting: # 8588
Views: 3,693

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. :-D

❝ Is there a limit as to how much overage is allowed?

No idea.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

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