varadpradhan
●    

2009-02-14 23:09
(6345 d 18:07 ago)

Posting: # 3242
Views: 6,458
 

 Differences in USFDA, ANVISA, EU, Japan, Canadian guidelines [Regulatives / Guidelines]

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Dear all,

Can I get difference in USFDA, ANVISA, EU, Japan, Canadian guidelines on bioanalytical method validation and subject sample analysis for BE studies. Are there any specific points to be considered while validating a bioanalytical method for different regulatory bodies? Please suggest any specific research paper and references for it.

Thanking you in advance.

Varad
 
Ohlbe
★★★

France,
2009-02-15 01:08
(6345 d 16:08 ago)

@ varadpradhan
Posting: # 3244
Views: 5,533
 

 Differences in USFDA, ANVISA, EU, Japan, Canadian guidelines

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Dear Varad,

Only the FDA and ANVISA have a bioanalytical validation guideline. You can find them both on the guidance page. EMEA has announced it will develop one, but this will obviously take some time.

Regards
Ohlbe
 
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