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RegisterBiowaiver for one strength/dose of non-linear PK [Design Issues]
Dear all,
Iam currently working on a BE study (with an anticancer drug) in cancer patients for EU submission. A higher dose is linear whilst the lower dose (in a different group of cancer patients) is non-linear. BE study with a higher dose can be planned. However, being rare condition, lower dose/strength cant be planned. Could the group members kindly help with providing a solution to waive BE study with the lower dose/strength (with non-linear pk) please? The irony is some patients in the main indication could also receive the lower dose/strength…recruitment of such patients will still be an issue. Has anyone received biowaiver for non-linear PK drug by conduct of a single study and justifying the non-conduct of the other?
Thank you for the kind help.
Kind regards,
Tina
Edit: Category changed; see also this post #1. [Helmut]
Iam currently working on a BE study (with an anticancer drug) in cancer patients for EU submission. A higher dose is linear whilst the lower dose (in a different group of cancer patients) is non-linear. BE study with a higher dose can be planned. However, being rare condition, lower dose/strength cant be planned. Could the group members kindly help with providing a solution to waive BE study with the lower dose/strength (with non-linear pk) please? The irony is some patients in the main indication could also receive the lower dose/strength…recruitment of such patients will still be an issue. Has anyone received biowaiver for non-linear PK drug by conduct of a single study and justifying the non-conduct of the other?
Thank you for the kind help.
Kind regards,
Tina
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Biowaiver for one strength/dose of non-linear PKTina 2016-05-26 13:58
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Ing. Helmut Schütz