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Replicate vs. 2×2×2 [Regulatives / Guidelines]

posted by M.tareq - 2017-05-14 23:04  - Posting: # 17353
Views: 9,516

Hi Helmut,

Thanks for your comprehensive reply and explanation,

» while ago I reviewed a manuscript exploring the pros and cons of TSDs vs. ABEL. Was very interesting and I hope that the authors submit a revised MS soon.

Can i get the link or the name of the paper when the authors submit it ?

In General, if a drug isn't known to be HVDP and by definition of HVDP that, they have wide therapeutic index yet the CRO/Sponsor went with replicate design.

How the assessor would consider that? mean if the published literature or pilot study suggest low CV of the reference /test product yet the cro/sponsor went with replicate design?

Like abusing the use of scABE ? :confused:

» Nobody knows how to deal with this story. :-( Regulations ≠ science. Not required by the FDA…

Agree, yet i read an ANDA submission -can't find the link now- where the sponsor detected outliers based on T/R ratio of each subject and redosing of such subjects along with other subjects who exhibited normal pkp profile; though it was after reviewing with FDA regulator.

Another published paper about ibandronic acid https://www.ncbi.nlm.nih.gov/pubmed/24756462 the sponsor/CRO stated the definition of outliers using studentized residuals and boxplot to eliminate subjects with values away from the boxplot by more than 3 IQR.

My point is, as your kindly said, it's best to state in the protocol how to deal with outliers especially regarding variability estimation and proving/showing to the assessor the reasons for excluding such outlier(s) from study or reviewing it with the regulator before submission of the data?

Thanks and Best Regards.

P.S:
Apologies for being information/knowledge leecher atm, will try to get my seed/leech ratio up ^^

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