Canada HVDS update [BE/BA News]

posted by vish14184 – India, 2016-04-20 21:22 (2898 d 22:45 ago) – Posting: # 16224
Views: 5,956

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:
  1. The scaled approached defined HVDS does not apply to veterinary or biological drug products.
  2. Change in acceptance criteria based on variability:
For human pharmaceutical drugs the following comparative bioavailability standards should be met:
  1. The 90% confidence interval of the relative mean AUC of the test to reference product should be within the following limits:
    1. 80.0%–125.0%, if sWR ≤0.294 (i.e., CV ≤30.0%);
    2. [exp(–0.76sWR) × 100.0%]–[exp(0.76sWR) × 100.0%] if 0.294 <sWR ≤0.534
      (i.e., 30.0% <CV ≤57.40%);
      or,
    3. 66.7%–150.0%, if sWR >0.534 (i.e., CV >57.4%).
  2. The relative mean AUC of the test to reference product should be within 80.0% and 125.0% inclusive;
  3. 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]

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