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RegisterHVDs/HVDPs: tricky business! [RSABE / ABEL]
posted by Helmut 
– Vienna, Austria, 2012-05-03 18:58 (5169 d 00:15 ago) – Posting: # 8507
Views: 10,367
Dear PTM139!
You didn’t tell us that you are dealing with a HVD/HVDP. As Dan already stated it is not that simple. Design of studies depend on the regulation:
❝ But irrespective of the cost chances of success are more in case of HVD?
You didn’t tell us that you are dealing with a HVD/HVDP. As Dan already stated it is not that simple. Design of studies depend on the regulation:
- US-FDA: Scaling allowed for AUC and Cmax, T/R-ratio restricted within 0.80–1.25, no clinical justification.
- EMA, Australia: Scaling allowed for Cmax only, T/R-ratio restricted within 0.80–1.25, clinical justification (safety) required, demonstration that CVWR>30% not caused by outliers.
- Canada: No scaling, but no assessment of the CI of Cmax – only T/R within 0.80–1.25.
- Russia: No scaling, but acceptance range of Cmax for all drugs 0.75–1.33 without justification.
- For others see the Guidance Collection.
- László Endrényi, László Tóthfalusi
Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs
J Pharm Pharmaceut Sci 15(1), 73–84 (2011)
online
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Helmut Schütz
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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. 🚮
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Complete thread:
- Full replicate design PTM139 2012-05-03 06:01
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Full replicate design Dr_Dan 2012-05-03 15:14
- Full replicate design PTM139 2012-05-03 16:35
- HVDs/HVDPs: tricky business!Helmut 2012-05-03 16:58
- HVDs/HVDPs: tricky business! PTM139 2012-05-05 07:16
- HVDs/HVDPs: tricky business! drsinghs 2012-05-09 12:33
- Ratio 125% Helmut 2012-05-09 13:05
- Ratio 125% drsinghs 2012-05-09 13:41
- Ratio 125%: reformulate Ohlbe 2012-05-09 16:40
- Ratio 125%: reformulate drsinghs 2012-05-10 05:49
- Ratio 125%: reformulate Ohlbe 2012-05-09 16:40
- Ratio 125% drsinghs 2012-05-09 13:41
- HVDs/HVDPs: tricky business! ElMaestro 2012-05-09 15:00
- HVDs/HVDPs: tricky business! drsinghs 2012-05-10 05:43
- Ratio 125% Helmut 2012-05-09 13:05
- HVDs/HVDPs: tricky business!Helmut 2012-05-03 16:58
- Full replicate design PTM139 2012-05-03 16:35
- Full replicate design Dr_Dan 2012-05-03 15:14
Ing. Helmut Schütz