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Of course, for an NME such knowledge may be years away from the compounds initial evaluation. Fda bcs classification. Although we believe it is quite easy, and using high throughput methods, to predict with good accuracy Class 1 and Class 2 versus Class 3 and Class 4 assignment of an NME, it is not easy to differentiate high solubility from low solubility. Thus, compounds with a lowest solubility over the pH range 1–7.5 being greater than 200μg/ml would be assigned Class 1 or Class 3 and those with a lowest solubility less than 200μg/ml would be assigned Classes 2 and 4. The major impediment is that the BDDCS (and BCS) solubility criterion is based on the highest marketed dose strength. Therefore we propose following the recommendation of Pfizer scientists to use a solublity cutoff of 200μg/ml (i.e., 50 mg highest dose strength) in the initial evaluation.
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