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RegisterIR vs MR [PK / PD]
Hi,
Are you referring to one IR table to one ER tablet? If so, no because that's not really the intent of a MR product. MR product has a slower rate of drug release -> 1) aim to lower the incidence of adverse events, 2) to provide a once daily blood level coverage (24 hrs).
Now I have seen submission in which BE was demonstrated between 1 MR tablet vs IR tablets given several times daily. Yes meeting the 90% CIs for AUC and Cmax. It was a 505(b)2 filing.
John
Are you referring to one IR table to one ER tablet? If so, no because that's not really the intent of a MR product. MR product has a slower rate of drug release -> 1) aim to lower the incidence of adverse events, 2) to provide a once daily blood level coverage (24 hrs).
Now I have seen submission in which BE was demonstrated between 1 MR tablet vs IR tablets given several times daily. Yes meeting the 90% CIs for AUC and Cmax. It was a 505(b)2 filing.
John
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