Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation
New Delhi: Rejecting the clinical trial waiver proposal, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Zydus Healthcare to conduct a bioequivalence study (BE) of Glycopyrrolate plus Indacaterol Maleate Metered dose inhalation.
This came after Zydus Healthcare presented a proposal along with BE protocol and justification for clinical trial waiver before the committee.
Glycopyrrolate is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, used with other medications to treat ulcers, and used in anesthesia. Glycopyrrolate is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long-acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications. Glycopyrronium is a muscarinic antagonist with the highest affinity for M1 receptors, followed by M3, M2/M4, and M5.
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