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Register§10(1) TO 10(3) shift due to altered BE results [Regulatives / Guidelines]
Dear all,
I am currently working on an IR generic product.The reference comparator SPC mentions no information of PK differences and meals. SD fed and fasted study was conducted for EU submission. The fasted study failed while the fed study passed. Though the product was developed as a generic 10(1), can the difference observed in the result be submitted as hybrid generic application and have specific wording in the SPC for taking the generic developed product with or after meals? Is this option acceptable? Thank you for your comments
I am currently working on an IR generic product.The reference comparator SPC mentions no information of PK differences and meals. SD fed and fasted study was conducted for EU submission. The fasted study failed while the fed study passed. Though the product was developed as a generic 10(1), can the difference observed in the result be submitted as hybrid generic application and have specific wording in the SPC for taking the generic developed product with or after meals? Is this option acceptable? Thank you for your comments
Complete thread:
- §10(1) TO 10(3) shift due to altered BE resultsTina 2013-05-24 18:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- §10(1) TO 10(3) shift due to altered BE results ElMaestro 2013-05-24 18:15
- §10(1) TO 10(3) shift due to altered BE results Shuanghe 2013-05-27 15:47
Ing. Helmut Schütz