Anand
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India,
2014-09-24 15:22
(4297 d 20:15 ago)

Posting: # 13564
Views: 3,411
 

 US ANDA submitted to Health Canada / RLD selection [Regulatives / Guidelines]

Dear All,

  1. Please clarify USFDA Filled ANDA product can be filled to Health Canada? Based on RLD Strength same in USA & Canada without doing BE study.

  2. US RLD product is not available in Canada, then how to select RLD in Canada for BE study?

Thanks in Advance

Regards,
Anand


Edit: Two posts merged; subject line adjusted to content. [Helmut]
Helmut
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Vienna, Austria,
2014-09-24 15:55
(4297 d 19:42 ago)

@ Anand
Posting: # 13566
Views: 2,715
 

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Hi Anand,
  1. With rare exceptions, no. In general the Canadian reference product has to be used. If you want to run only one study (instead of two cross-overs), perform a three-period study with the US RLD, the Canadian reference, and your test product.
  2. Please [image] search the forum first (see the Policy). You easily would have found this thread and the link to Canada’s Drug Product Database.

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Anand
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India,
2014-09-25 08:15
(4297 d 03:22 ago)

@ Helmut
Posting: # 13575
Views: 2,693
 

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Dear Helmut,

Thanks for your help.

Regards,
Anand
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