Submit Phase III CT data with Pk and Pd data: CDSCO Panel Tells Intas Pharmaceuticals on Human von Willebrand Factor
New Delhi: In response to the proposal for the grant of permission to manufacture Human von Willebrand Factor EP 600 IU (Freeze Dried Powder) Drug Formulation, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended that Intas Pharmaceutical submit the Phase III clinical trial data with pharmacokinetics (Pk) and pharmacodynamic (Pd) data of the proposed drug.
In addition, the committee recommended that the firm may submit the protocol of the study for consideration.
This came after the firm presented the proposal for a grant of permission to manufacture the Human von Willebrand Factor EP 600 IU (Freeze Dried Powder) drug formulation with a local clinical trial (CT) Phase-III waiver.
Von Willebrand factor is a human blood clotting factor used to manage bleeding episodes in von Willebrand disease and hemophilia A.
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