PharmPK Discussion - Single dose ER vs Multiple dose IR Drug-Which Tmax

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On 16 Apr 2016 at 09:38:21, MaulikJ.Patel.aaa.sunpharma.com sent the message

	
Dear All,

We are planning to develop Extended-Release Formulation against the already approved
Immediate-release formulation of one drug.

Study design: 2-treatment, 2-period, 2-sequence single dose vs. multiple dose relative
bioavailability study.

Test drug (Extended Release formulation) is to be given as single dose in the morning and Reference
drug (Immediate Release) is to be given two times in a day at 12.0 hours interval.

Now the real discussion point comes:

As Reference product will be given two times in a day at 12.0 hours interval, there will be total
two Cmax (means two Tmax where maximum concentration achieved).

So if i wish to conclude the results of ER formulation against IR formulation, which Tmax (rather
Cmax also) should I consider for the reporting (i.e. The Tmax reported after the first dosing or
Tmax which is actually a highest value among the two Tmax).

Please note that the molecule does not have the inherent property of giving two distinct peak after
single dosing.

Also, please suggest additionally any partial AUC (i.e. AUC after each dosing) and Cmax after each
dosing required to report or not.

Thanks in advance.

Regards,
Maulik Patel

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On 1 Aug 2016 at 12:30:28, Jaime Algorta (jaime.algorta.at.ehu.es) sent the message
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If the target territory is EMA, have a look to EMA/CHMP/EWP /280/96 (2015) guideline.

JaiPhone
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