Log in
Register|
rajasekhar ☆ India, 2017-02-18 12:36 (2616 d 22:34 ago) Posting: # 17080 Views: 3,340 |
|
|
Dear All, My doubt is suppose participant completed entire period and he having the plasma samples for all time points but during bio analysis we got only 3 measurable concentrations. In this case is we can consider this data for PK and statistical evaluations. Is there any regulation for minimum measurable concentrations to perform statistical analysis. please let me know is there any supportive guidelines for same. Thank you in advance  |
|
ElMaestro ★★★ Denmark, 2017-02-18 13:44 (2616 d 21:26 ago) @ rajasekhar Posting: # 17082 Views: 2,793 |
|
|
Hi rajasekhar, ❝ Is there any regulation for minimum measurable concentrations to perform statistical analysis. please let me know is there any supportive guidelines for same. This is where you need an SOP and not a guideline. Wit three values above the LLOQ the profile for that subject's data is rubbish but in the absence of an SOP you may need to include it still. Perhaps the EMA's Cmax:LLOQ requirement comes to some degree of rescue. — Pass or fail! ElMaestro |
|
Ohlbe ★★★ France, 2017-02-20 12:59 (2614 d 22:11 ago) @ rajasekhar Posting: # 17091 Views: 2,803 |
|
|
Dear Rajasekhar, ❝ My doubt is suppose participant completed entire period and he having the plasma samples for all time points but during bio analysis we got only 3 measurable concentrations. In this case is we can consider this data for PK and statistical evaluations. If this happens in the period where the subject received the test product, you're in trouble... To quote the EMA guideline, section 4.1.8: Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics. The exceptions to this are: 1) A subject with lack of any measurable concentrations or only very low plasma concentrations for reference medicinal product. A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject). The exclusion of data due to this reason will only be accepted in exceptional cases and may question the validity of the trial. — Regards Ohlbe |
|
nobody nothing 2017-02-20 15:35 (2614 d 19:35 ago) @ Ohlbe Posting: # 17092 Views: 2,734 |
|
|
...I concur Ohle and want to add: an SOP for "PK outlier detection" won't buy you much in the light of the crystal clear guideline on this topic. Sometimes you loose, sometimes the others win  — Kindest regards, nobody |
Ing. Helmut Schütz