Bioequivalence and Bioavailability Forum • Lansoprazole draft guideline and replicate design

Ravi
★

India,
2009-04-01 13:24
(5889 d 00:21 ago)

Posting: # 3436
Views: 4,931

Lansoprazole draft guideline and replicate design [RSABE / ABEL]

Dear All,

In the draft guidline for Lansoprazole (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm086284.pdf) it is mentioned that
"The within-subject variability of the reference product is determined in a 3-way modified replicate-design study in which the reference product is given twice and the test product is given once".

Now my question is what is meant by 3-way modified replicate-design and how does it differs from usual 2 treatment, 2 sequence, 3 period replicate design (TRT/RTR) recommended by FDA.

Can we use 2 treatment, 3 sequence, 3 period replicate design i.e RTR/TRR/RRT. Wheather this design will be acceptable to FDA or not and Please also tell me if above mentioned design is balanced or not.

By using above mentioned replicate design can we get the Intra CV for reference and use it for Reference scaling average bioequivalence apporach.

Thanks for ur replies in advance.

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Thanks & Regards
Ravi Pandey

MGR
★

India,
2009-04-01 16:39
(5888 d 21:06 ago)

@ Ravi
Posting: # 3438
Views: 3,801

Lansoprazole draft guideline and replicate design

Post reply

Dear Ravi,

❝ Can we use 2 treatment, 3 sequence, 3 period replicate design i.e RTR/TRR/RRT. Wheather this design will be acceptable to FDA or not and Please also tell me if above mentioned design is balanced or not.

The above reference replicated design will be acceptable by the USFDA. And the following link having that thread, may helps you regarding the design and analysis of RSABE

❝ By using above mentioned replicate design can we get the Intra CV for reference and use it for Reference scaling average bioequivalence apporach.

Yeah definitely we will get the Intra CV for reference. As this design is for that purpose only.
(For example if you are dealing with 2 treatment 4 period 2 seq replicated design you will get the intra subject CV for test and Reference individually like in the same way we will get only for Reference in this type of design.)

Thank you.

—
Regards,
MGR