Predose concentration more than 5 % of Cmax [Regulatives / Guidelines]
Hello All,
Please provide your input for the following,
As per the FDA guideline
If the pre-dose concentration is ≤ 5 percent of the Cmax value in a subject with a pre-dose plasma concentration, applicants can include the subject’s data without any adjustments in all PK measurements and calculations. We recommend that if the pre-dose value is > 5 percent of the Cmax, applicants drop the subject from all BE study evaluations.
My question here is,
In a BE study of FDC (or drug with two isomers), If any subject had pre-dose > 5 percent of the Cmax for one drug (or one isomer), What should be followed
NK
Please provide your input for the following,
As per the FDA guideline
If the pre-dose concentration is ≤ 5 percent of the Cmax value in a subject with a pre-dose plasma concentration, applicants can include the subject’s data without any adjustments in all PK measurements and calculations. We recommend that if the pre-dose value is > 5 percent of the Cmax, applicants drop the subject from all BE study evaluations.
My question here is,
In a BE study of FDC (or drug with two isomers), If any subject had pre-dose > 5 percent of the Cmax for one drug (or one isomer), What should be followed
- Drop the subject from the statistical analysis of both the drug (or both the isomer) or
- Drop only for the statistical analysis of a drug (or a isomer) for which the pre-dose observed was > 5 percent of the Cmax and include for other drug (or isomer).
NK
Complete thread:
- Predose concentration more than 5 % of CmaxNK 2024-08-05 06:07
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36
- FDC or isomers: C0 > 5 % of Cmax Achievwin 2024-08-05 19:08
- Carryover. A Never Ending Story. Helmut 2024-08-05 22:39
- Inducers/inhibitors Ohlbe 2024-08-08 18:09
- Inducers/inhibitors Helmut 2024-08-09 08:26
- FDC or isomers: C0 > 5 % of Cmax Achievwin 2024-08-05 19:08
- Predose concentration more than 5 % of Cmax qualityassurance 2024-08-05 12:48
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36