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RegisterTablet vs Capsule [Design Issues]
Dear Noha,
Have a look not at the BE guideline, but at Directive 2001/83/EC, Article 10, paragraph 2(b), in the definition of a generic medicinal product:
‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. [...] The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form.
❝ Could you please refer me to the part of the guideline that says that.
Have a look not at the BE guideline, but at Directive 2001/83/EC, Article 10, paragraph 2(b), in the definition of a generic medicinal product:
‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. [...] The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Tablet vs Capsule MGR 2007-11-26 12:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Tablet vs Capsule H_Rotter 2007-11-26 14:42
- Tablet vs Capsule Noha Abdeljawad 2014-08-25 11:20
- Tablet vs CapsuleOhlbe 2014-08-25 11:57
- Tablet vs Capsule Noha Abdeljawad 2014-08-25 11:20
- Tablet vs Capsule H_Rotter 2007-11-26 14:42
Ing. Helmut Schütz