Ramesh Ramalingam
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India,
2019-01-21 12:33
(2713 d 04:33 ago)

Posting: # 19795
Views: 2,639
 

 Acetylsalicyclic Acid + Glycine Tablet [Design Issues]

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Dear Members,

I couldn't get any literature and/or product specific bio-equivalence guidelines to conduct fixed dose combination of Acetylsalicyclic Acid + Glycine Tablet. We decided to conduct a BE study for EMA submission.

Could you please suggest whether we required to estimate both Acetylsalicyclic Acid + Glycine?
 
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