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RegisterAUC and Cmax [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2015-07-02 19:37 (4016 d 09:58 ago) – Posting: # 15024
Views: 10,275
Dear Dr. S. Gunasakaran,
Last year HC considered FDA’s approach (see here). On many previous occasions HC stated that they don’t see any need for changing the requirement for Cmax since for more than two decades only the T/R-ratio had to be contained within 80–125%, which – in HC’s opinion – was never an obstacle considering the necessary sample sizes. László Endrényi and László Tóthfalusi showed many times that for high CVs (say ≥50%) only the restriction on the point estimate leads the BE-decision (irrespective of the scaling method).
Therefore, I understand the logic behind:
❝ It's surprising to see that the HVDP classification is based on the within subject coefficient of variation of AUC alone and not based on AUC and/or Cmax.
Last year HC considered FDA’s approach (see here). On many previous occasions HC stated that they don’t see any need for changing the requirement for Cmax since for more than two decades only the T/R-ratio had to be contained within 80–125%, which – in HC’s opinion – was never an obstacle considering the necessary sample sizes. László Endrényi and László Tóthfalusi showed many times that for high CVs (say ≥50%) only the restriction on the point estimate leads the BE-decision (irrespective of the scaling method).
Therefore, I understand the logic behind:
- Keep the current method for Cmax – which served well for ages.
- Allow reference-scaling of AUC.
—
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 09:05 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 CmaxHelmut 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
Ing. Helmut Schütz