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hiren379 ★ India, 2011-08-09 05:22 (5082 d 07:56 ago) Posting: # 7277 Views: 4,902 |
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Hello Friends, What shall be done if T/R for single subject is around 1000 due to very low R value. No issues in clinical/bio analytical conduct. As per EU we calculated whether its AUC is less than 5% of average GLSM for reference. But the value comes to 5.80 Please guide. Will this work to exclude the subject. It was a FDC where in the concentration of second drug is 0 but may be our method for first drug was good enough  to measure these limited concentrations...Edit: For beginners: FDC = Fixed Dose Combination (Product) [Helmut] |
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d_labes ★★★ Berlin, Germany, 2011-08-10 12:07 (5081 d 01:10 ago) @ hiren379 Posting: # 7278 Views: 4,027 |
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Dear Hiren! ❝ What shall be done if T/R for single subject is around 1000 due to very low R value. No issues in clinical/bio analytical conduct. ❝ ❝ As per EU we calculated whether its AUC is less than 5% of average GLSM for reference. ❝ ❝ But the value comes to 5.80  Did you calculate the geometric mean of the AUC of the Reference without the aberrant value?EMA guidance page 14: "...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)..." Emphasis by me. I would expect a ratio T/R around 20 if the aberrant value is 5% of the mean. — Regards, Detlew |
Ing. Helmut Schütz