Naproxen ER FDA guidance [Regulatives / Guidelines]

posted by sunny – 2014-04-25 04:43 (4442 d 11:36 ago) – Posting: # 12893
Views: 4,277

(edited on 2014-04-25 10:10)

I think the issue here is how critical the early exposure is. If early exposure is not so important based ER product's approved indications, the partial AUC may not be justified. In the case of methylphenidate and ambien, early exposure is extremely important for the onset of effect (inducing focusing and inducing sleep, respectively). In my view, the early exposure of naproxen is a little difficult to be justified. I would like to hear my thoughts from you all.

Thanks,
Sunny


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan]

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