Canada HVDS update [BE/BA News]
Dear All,
Health Canada published Policy on Bioequivalence Standards for Highly Variable Drug Products on 18th April 2016.
Please refer below link for your ready reference.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice-avis-be-hvdp-nb-pphv-eng.php
main points:The relative mean AUC of the test to reference product should be within 80.0% and 125.0% inclusive;
The relative mean maximum concentration (Cmax) of the test to reference product should be between 80.0% and 125.0% inclusive.
With Regards,
Vishal Nakrani
Edit: THX for posting! Category changed. [Helmut]
Health Canada published Policy on Bioequivalence Standards for Highly Variable Drug Products on 18th April 2016.
Please refer below link for your ready reference.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice-avis-be-hvdp-nb-pphv-eng.php
main points:
- The scaled approached defined HVDS does not apply to veterinary or biological drug products.
- Change in acceptance criteria based on variability:
- The 90% confidence interval of the relative mean AUC of the test to reference product should be within the following limits:
- 80.0%–125.0%, if sWR ≤0.294 (i.e., CV ≤30.0%);
- [exp(–0.76sWR) × 100.0%]–[exp(0.76sWR) × 100.0%] if 0.294 <sWR ≤0.534
(i.e., 30.0% <CV ≤57.40%); or,
- 66.7%–150.0%, if sWR >0.534 (i.e., CV >57.4%).
With Regards,
Vishal Nakrani
Edit: THX for posting! Category changed. [Helmut]
Complete thread:
- Canada HVDS updatevish14184 2016-04-20 19:22
- Canada HVDS update jag009 2016-04-20 21:22
- at best half baked Helmut 2016-04-21 00:43
- Canada HVDS update jag009 2016-04-20 21:22