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FDA-Subject by formulation interaction (Switchability) [Regulatives / Guidelines]

posted by sudy - India, 2018-03-28 07:09  - Posting: # 18598
Views: 746

Dear all,

I have a discussion point regarding switchability criteria for methylphenidate 54mg tabs (specially). For lower strength, they have removed this criterion.

As per guideline, we have to meet the ABE criteria and additionally meet 95% UB for switchability.

Now, as we are doing a fully replicate study as suggested by OGD recommendation on methylphenidate, can we use RSABE approach in case if we get ISCV-reference > 30% for any one of the PK parameter Cmax or partial AUCs, instead of using 90% CI calculation to prove the bioequivalence?

The OGD recommendation did not discuss anything about this case, as we know that methylphenidate is not a HVD. But incase if we got CV-R more than 30%, can we apply RSABE?

Your suggestion will be highly appreciated.

Regards,
Sudy

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