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Smitha ☆ India, 2012-12-04 10:36 (4541 d 15:50 ago) Posting: # 9668 Views: 6,861 |
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Dear all, I had a query regarding handling of subjects with first point Cmax. Details as below: Reported Tmax- 4 to 6hrs Time points selected for the study: 0 hr, 0.5hr (30mts), 1 hr, 1.5hr, 2, 2.5 hr and so-on On completion of the study, it was observed that 1 subject had the first sampling time point (0.5hr) as the Cmax. This was a submission study and the FDA guideline requirements of first sampling point within 15mts of dosing and 2-5 timepoints within the first hour of dosing, were not included in the study design. SOP does not address handling of the same. Request clarifications/opinions on the following
Thanks Edit: Category changed. [Helmut] |
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Dr_Dan ★★ Germany, 2012-12-04 11:35 (4541 d 14:50 ago) @ Smitha Posting: # 9670 Views: 6,202 |
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Dear Smitha To my opinion there is no justification to exclude the subject with first point Cmax from PK and Statistical analysis. First of all you have to check if this occurred under Test because then you maybe have to face a formulation problem (dose dumping -> serious risk to public health). Next you should check if the first concentration measured is within the range of Cmax of the study. If not and above the range, than you have a problem. Otherwise evaluate the full data set and if the study passes perform a sensitivity analysis by replacing the first concentration measured by the highest Cmax measured in the study. If the study still passes than try to find the highest Cmax value for this subject that still allows to conclude bioequivalence and discuss why the first concentration measured is supposed to be the Cmax of the subject. Do not exclude the subject from PK and Statistical analysis. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Smitha ☆ India, 2012-12-08 07:24 (4537 d 19:02 ago) @ Dr_Dan Posting: # 9694 Views: 5,564 |
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Dear Dr. Dan, Thank you for the response, has given us food for thought Helmut/El maestro/d_labes/Dr. Gunashakaran: Will appreciate your opinions on the same Thanks |
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d_labes ★★★ Berlin, Germany, 2012-12-09 20:16 (4536 d 06:10 ago) @ Smitha Posting: # 9699 Views: 5,495 |
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Dear Smitha, since called upon: You may get a lot of opinions of the persons you are calling regarding your subject line if you use the search feature of the forum. Hint: The search box is located in the right upper corner  .— Regards, Detlew |
Ing. Helmut Schütz