Acetylsalicyclic Acid + Glycine Tablet [Design Issues]

posted by Ramesh Ramalingam  – India, 2019-01-21 11:33 (1009 d 23:45 ago) – Posting: # 19795
Views: 1,262

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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