Enantiomer measurement for metabolite [Design Issues]

posted by msmnainar – India, 2012-12-20 09:36 (4932 d 10:05 ago) – Posting: # 9734
Views: 3,901

Hello all

I need clarification regarding the measurement of metabolite for those drug having racemic activity.

Both parent and its metabolites exhibit linear kinetics and its linear in pharmacokinetics, as per product label.

However, both parent and its metabolites exposure are different, as per literatures.

The study is for TGA submission.

Thanks and regards
MSMN

Sundar. M

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