srinivasu
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2011-12-21 13:43
(5305 d 17:13 ago)

Posting: # 7798
Views: 2,391
 

 For BE Choosing the strength class-II Drug [Regulatives / Guidelines]

Dear all,
we are developing the formulation for class-II Drug (tablet dosage form 10, 20 mg) as per the customer request. RLD is available 80 mg
Which strength we have to choose for BE studies. Pl reply ASAP with all relevant information.

WITH RGDS,
SRINIVASU.K
Helmut
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Vienna, Austria,
2011-12-21 16:49
(5305 d 14:07 ago)

@ srinivasu
Posting: # 7802
Views: 1,918
 

 Homework?

Dear Srinivasu!

❝ we are developing the formulation for class-II Drug (tablet dosage form 10, 20 mg) as per the customer request. RLD is available 80 mg

❝ Which strength we have to choose for BE studies.


See this post first. When you are talking about ‘RLD’ chances are high that FDA has issued a product-specific guidance already.

❝ Pl reply ASAP with all relevant information.


ASAP immediately sends me into slow motion. I’m not your employee – please do your homework first. What have you done already, which are your conclusions so far?


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