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Register3x3 or 2x4? [RSABE / ABEL]
Hi Felipe! How are you my friend?
In my opinion, as the my focus is generics drugs products, I suggest the implementation of a reference scaled average bioequivalence using a 4x2 design. Because with test and reference formulations replicated the statistical adjustment is more consistent. Because you have more information from two medicines. In addition, the 4x2 design gives you a real information about your product that can be used in an internal discussion to improve your formulation in case of bioequivalence study fail.
More information read:
Implementation of a Reference Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration.
The AAPS Journal, Vol.14, No.4, December2012
doi 10.1208/s12248-012-9406-x
Best regards
In my opinion, as the my focus is generics drugs products, I suggest the implementation of a reference scaled average bioequivalence using a 4x2 design. Because with test and reference formulations replicated the statistical adjustment is more consistent. Because you have more information from two medicines. In addition, the 4x2 design gives you a real information about your product that can be used in an internal discussion to improve your formulation in case of bioequivalence study fail.
More information read:
Implementation of a Reference Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration.
The AAPS Journal, Vol.14, No.4, December2012
doi 10.1208/s12248-012-9406-x
Best regards
Complete thread:
- 3x3 or 2x4? felipeberlinski 2014-10-22 14:20 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 3x3 or 2x4? ElMaestro 2014-10-22 14:42
- 3x3 or 2x4? nobody 2014-10-22 15:06
- 3x3 or 2x4? felipeberlinski 2014-10-22 15:36
- 3x3 or 2x4? nobody 2014-10-22 15:41
- 2x3x3 or 2x2x3 or 2x2x4? d_labes 2014-10-22 16:12
- 2x3x3 or 2x2x3 or 2x2x4? MGR 2015-04-08 13:35
- Sample size for scABE in SAS? d_labes 2015-04-08 16:06
- Re-inventing the wheel Helmut 2015-04-08 16:19
- 2x3x3 or 2x2x3 or 2x2x4? MGR 2015-04-08 13:35
- 3x3 or 2x4? felipeberlinski 2014-10-22 15:36
- 3x3 or 2x4? nobody 2014-10-22 15:06
- RTR|TRT Helmut 2014-10-22 16:36
- 3x3 or 2x4?Mauricio Sampaio 2014-10-28 12:12
- 3x3 or 2x4? ElMaestro 2014-10-22 14:42
Ing. Helmut Schütz