- On 16 Jul 2015 at 08:56:35, akasam satishkumar (akasamsatishkumar.at.gmail.com sent the message

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Dear all,

As we know for NTI drugs guidelines Warfarin has suggested that use both (1) scaled and unscaled

ABE, in addition to that (2) calculation of 90% CI of ratio of within subject standard deviation of

test to reference product.

Here my problem is (2). i don't know how to calculate (2). but i tried it with 'COVPRMS' of 'PROC

MIXED' from normal ln transformed data (not from ilat, dlat). i calculated within subject standard

deviation for test and reference using 'estimates' in 'COVPRMS'. now i just want to know am i doing

it in the correct way or not?

Thanks and Regards,

Satish.

[NTI? - db] - On 16 Jul 2015 at 11:40:04, nanzh.at.UMICH.EDU sent the message

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Satish,

For (2), please refer to the BE recommendation for warfarin

(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201283.pdf)

. It has a step-by-step instruction on how to use SAS to calculate the within subject variabilty.

You can also refer the FDA guidance: statistical approaches to establish BE

(http://www.fda.gov/downloads/Drugs/Guidances/ucm070244.pdf). The appendix contains instructions on

how to calculate within subject standard deviation, if you are using other software.

Sincerely,

Nan

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