Bioequivalence and Bioavailability Forum

Hi Compliance,

❝ I think you are getting irritated and I am sorry for that.

I was; already forgotten.

I have to modify my original response of “no way”. Actually there are some exceptions acceptable. See Canadian Reference Product ❝ Background.
If all applicable criteria are fulfilled, a foreign reference product may be used in a BE study for generic filing.

Hi John,

❝ Thanks to Helmut, I have learned many new things and corrected a lot of my old believes from all the contributors here.

Thanks to you we got some opinions about North-American practices straight from the horse’s mouth. Unfortunately you guys are in the minority here (US 2.84%, Canada 2.36%, Mexico 0.83%).
  571 (67.49%) India
  121 (14.30%) Europe (107 = 12.65% EEA)
   55 ( 6.50%) Asia (except India)
   51 ( 6.03%) North America
   22 ( 2.60%) Africa and Middle East
   14 ( 1.65%) Central and South America
   12 ( 1.42%) Oceania
  ───
  846
In the last months I deleted hundreds of members who never posted or didn’t show up for more than five years. There are fewer active members than the actual number suggest. Hence, nobody should expect an immediate response. How many regular posters do we have?
≥ 20 posts: 70 members (8.27% of 846) from 22 countries (⅓ of 66)
≥ 50 posts: 17 members (2.01%) made 6296 posts (58.48% of all)
            44.28% (from Austria, 2 members), 16.09% (Germany 3), 11.69% (Denmark 1),
            8.97% (France 1), 5.84% (India 5), 4.83% (USA 1),
            3.57% (Taiwan 1), 2.70% (Spain 1), 1.03% (UK 1),
            0.98% (Romania 1)
≥100 posts: 10 members (1.18%) made 5892 posts (54.73% of all)
            47.32% (Austria 2), 16.33% (Germany 2), 12.49% (Denmark 1),
            9.59% (France 1), 5.16% (USA 1), 3.82% (Taiwan 1),
            2.89% (Spain 1), 2.41% (India 1)

94 members fall into my private category of “information sinks”: Only one post and never showing up again (not even to say “THX”).

In short: If you post here, chances are high that you’ll get a biased answer (गुरुओं opinions).
Science ≠ democracy.

Since I’m guilty for almost ¼ of all posts –
maybe I should exercise restraint. Will try.
मैं सभी पदों में से लगभग एक चौथाई के लिए दोषी हूँ -
शायद मैं संयम बरतने चाहिए. कोशिश करेंगे.
আমি সব পোস্ট এর প্রায় এক চতুর্থাংশ জন্য দোষী নই দেখাও -
হয়তো আমি যম ব্যায়াম করা উচিত. চেষ্টা করবে.
నేను అన్ని పోస్ట్స్ ని దాదాపు త్రైమాసికంలో నేరాన్ని రెడీ నుండి -
నేను నిగ్రహం వ్యాయామం చేయాలి. ప్రయత్నిస్తుంది.
मी सर्व पोस्ट जवळजवळ एक तिमाहीत दोषी am असल्याने -
मी संयम व्यायाम करावा. प्रयत्न करू.
நான் எல்லாம் கிட்டத்தட்ட ஒரு காலாண்டில் குற்றவாளி இல்லை என்பதால் -
ஒருவேளை நான் கட்டுப்பாடு பின்பற்ற வேண்டும். முயற்சிக்கும்.
میں نے تمام خطوط کے تقریبا ایک سہ ماہی کے لئے مجرم ہوں چونکہ
شاید میں سنیم چاہئے. کوشش کریں گے.
હું બધી પોસ્ટ્સ લગભગ એક ક્વાર્ટર માટે દોષિત છું ત્યારથી -
કદાચ હું સંયમ વ્યાયામ કરીશું. પ્રયત્ન કરશે.
ನಾನು ಎಲ್ಲಾ ಪೋಸ್ಟ್ಗಳನ್ನು ಸುಮಾರು ಒಂದು ತ್ರೈಮಾಸಿಕ ತಪ್ಪಿತಸ್ಥ ಮನುಷ್ಯ ನಂತರ -
ಬಹುಶಃ ನಾನು ಸಂಯಮ ವ್ಯಾಯಾಮ ಮಾಡಬೇಕು. ಪ್ರಯತ್ನಿಸುತ್ತೇವೆ.

To all,

Thank you very much for your reply. I found few links which give us direct access to the Canada Reference product. Site having some confusion (at least at my end).

Hope this link will be helpful.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Regards,

Compliance

Hi Luvbloom,

❝ I have an experience with one derma product where the clinical studies (PK and PD both) has been done using US innovator product and the same was submitted to Health Canada (along with the tests and data showing that both the reference i.e. US and Canada are same).

❝

❝ After a few basic question on the testing methodology and few suggestions the product got approved!

Same here, mine was a 3-way oral admin study for a 505(b)2 filing of a once daily ER vs innovator twice daily. We submitted both CAN and US reference data. No issue with TPD in Canada (or USA FDA). Product was approved.

John