CDSCO Committee Recommends SpinoS to Conduct BE Study with Vitamin D Screening Conditions
New Delhi: The SpinoS Lifescience And Research has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the BE study of Vitamin D3 liposomal oral solution.
However, this approval is subjected to the condition that the firm should Screen the volunteers for Vit-D baseline levels and volunteers having normal Vit-D levels should enroll in the study and before check-in of period II, Vit-D levels should be monitored and volunteers having normal Vit-D levels only be continued in the study.
In addition, the committee recommended the firm to submit the revised protocol to CDSCO for further review.
This came after the firm presented the revised Protocol No.SLS-CT-0007-24-VITA Version No.04 Protocol Date 24 Apr 25.
Cholecalciferol (vitamin D3) is in a class of medications called vitamin D analogs. Cholecalciferol is needed by the body for healthy bones, muscles, nerves, and to support the immune system. It works by helping the body to use more of the calcium found in foods or supplements.
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