Which model? [Regulatives / Guidelines]
Hi Lucas,
To me it is not clear which statistical model HC prefers (see this post). Sounds like a mixed-effects model (FDA’s 2001 guidance, FDA’s progesterone guidance / unscaled ABE, EMA’s Method C) to me. Only then one may run into convergence issues. No problem with EMA’s crippled models (Methods A [subjects fixed] and B [subjects random]).
You can, of course. This forum is not censored.
❝ I do not like partial replicate designs also. I have a feeling that, taking those converging problems aside, …
To me it is not clear which statistical model HC prefers (see this post). Sounds like a mixed-effects model (FDA’s 2001 guidance, FDA’s progesterone guidance / unscaled ABE, EMA’s Method C) to me. Only then one may run into convergence issues. No problem with EMA’s crippled models (Methods A [subjects fixed] and B [subjects random]).
❝ … having 2x more data of one treatment than the other is not good for the estimations. Seems like you give more chances for one treatment to show its "real PK profile". Could I say that?
You can, of course. This forum is not censored.

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Complete thread:
- HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 09:05 [Regulatives / Guidelines]
- HC Proposed Policy on Bioequivalence Standards for HVDS d_labes 2015-07-02 09:19
- Bloody partial replicate again Helmut 2015-07-02 13:20
- Bloody partial replicate again Lucas 2015-07-02 13:35
- Which model?Helmut 2015-07-02 16:41
- Which model? Lucas 2015-07-02 18:06
- Which model?Helmut 2015-07-02 16:41
- Bloody partial replicate again Lucas 2015-07-02 13:35
- HC Proposed Policy on Bioequivalence Standards for HVDS drgunasakaran1 2015-07-02 17:08
- AUC and Cmax Helmut 2015-07-02 17:37
- HC for HVDs d_labes 2015-07-03 08:21
- HC for HVDs Helmut 2015-07-03 11:55
- Rounding d_labes 2015-07-03 12:53
- Acceptable difference (BE history) Helmut 2015-07-03 14:49
- Off topic ElMaestro 2015-07-03 13:02
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
- Playing around with α (not exactly brilliant) ElMaestro 2015-07-03 16:35
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 16:44
- OT – Philosophers on duty d_labes 2015-07-03 21:11
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 16:44
- Playing around with α (not exactly brilliant) ElMaestro 2015-07-03 16:35
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
- Rounding d_labes 2015-07-03 12:53
- HC for HVDs Helmut 2015-07-03 11:55