raghavendra_s
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2010-02-01 06:55
(5987 d 19:30 ago)

Posting: # 4671
Views: 3,752
 

 Sodium Hyaluronate [Design Issues]

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Dear Friends,

How to assess the euivalence for Generic Sodium HYALURONATE Injections for Osteoarthritis?

Is it required only Clinical End Point study or also the Bioequivalence Study?

Any suggestions on this.

Kind regards,
 
Helmut
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Vienna, Austria,
2010-02-01 14:09
(5987 d 12:16 ago)

@ raghavendra_s
Posting: # 4676
Views: 2,998
 

 Sodium Hyaluronate

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Dear Raghavendra!

❝ How to assess the euivalence for Generic Sodium HYALURONATE

❝ Injections for Osteoarthritis?

❝ Is it required only Clinical End Point study or also the Bioequivalence

❝ Study?

  1. Do you believe you can show superiority to placebo with this kind of product? You know that there's no clear clinical evidence of efficacy yet.
  2. No way. The daily turnover of hyalurnic acid are a couple of grams - you will never be able to see a shift against such high endogenous levels.
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Ohlbe
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France,
2010-02-01 14:53
(5987 d 11:32 ago)

@ raghavendra_s
Posting: # 4679
Views: 2,961
 

 Drug or medical device ?

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Dear Raghavendra,

If I'm not mistaken sodium hyaluronate is considered as a medical device in some countries, when injected in joints to treat osteoarthritis. The requirements would then be totally different. Check the regulations in the country where you intend to make your application.

Regards
Ohlbe
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Regards
Ohlbe
 
raghavendra_s
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2010-02-02 06:38
(5986 d 19:47 ago)

@ Ohlbe
Posting: # 4691
Views: 3,066
 

 Drug or medical device ?

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Dear Helmut and Ohlbe,

Thank you very much for valuable information.

As it is an intra-articular injection for Osteoarthritis. Probably in India, it would be Drug.

Being it a local injection, how one can go ahead with design of a study which involves a three arm study viz. Placebo, Reference and Test.

A information is higly aprreciated,

Thanks in advance,

Kind regards
 
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