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RegisterPediatric formulation [Regulatives / Guidelines]
Dear Phaneendra,
No. A BE would be done in healthy subjects. A therapeutic equivalence study would be done in patients i.e. children who would need the treatment.
Regards
Ohlbe
No. A BE would be done in healthy subjects. A therapeutic equivalence study would be done in patients i.e. children who would need the treatment.
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Pediatric formulation ioanam 2009-05-27 09:52 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Pediatric formulation Helmut 2009-05-27 12:10
- Pediatric formulation Ohlbe 2009-05-27 13:37
- Pediatric formulation Phaneendra.K 2010-12-31 15:11
- Pediatric formulationOhlbe 2010-12-31 15:57
- Pediatric formulation Phaneendra.K 2010-12-31 15:11
- Pediatric formulation Ohlbe 2009-05-27 13:37
- Pediatric formulation Helmut 2009-05-27 12:10
Ing. Helmut Schütz