What are the proposed changes in the REPORTABLE RANGE as per the Draft ICH guideline -Q2(R2)

What are the proposed changes in the REPORTABLE RANGE as per the Draft ICH guideline -Q2(R2)
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[@petaravi5722]

nice explanation sir

[@arijitdasgupta903]

I was little bit confused till now, but this video has eliminate all confusion and doubts

[@riyazshaik6299]

Very Good work sir... please give more examples for better understanding for beginners also.....

[@sandeepchilamkurthi8022]

Can u explain the difference between working range and reportable range

[@sivaramach1]

You said 1st point disso release 60% at 10min. Then lower limit would be 15% not 25% sir.

[@arijitdasgupta903]

One question is that how can we determine QL in dissolution testing for modified release dosage form

[@ashutoshsehgal8243]

Hello sir in dissolution testing you example about time point and there you mention 60% limit of dissolution . Acc. To Q-45% how you elaborate 60% to 25% if you said Q-45% is absolute

[@heshamel-maghrabi8127]

Hello sir, in the last q2R1 guideline. In the dissolution test for SR dosage the limit was Q-20% of the lower limit. The example was 20%at 1st hour so we start from zero - and that was an issue - so, it's not clear for me the modification done at this point in the new R2 guideline So, please clarify what should be done for SR dosage for range. Thanks

[@pharmagrowthhub3083]

MR: The range must be evaluated from LOQ to 120% of LC

[@rahulaher5990]

Sir please make a detail videos about preperative Hplc

[@vgs4u790]

Next part of ich ich Q2(R2) please