Conduct bioequivalence study: CDSCO Panel Tells Cipla on Arsenic Trioxide Oral Solution
New Delhi: In response to a proposal presented by drug major Cipla for manufacturing and marketing of the chemotherapeutic agent Arsenic Trioxide Oral Solution, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to conduct bioequivalence (BE) study and submit the report.
This came after the drug major Cipla presented its proposal for the manufacture and marketing of Arsenic Trioxide Oral Solution 1mg/ml-5ml (additional dosage form and Indication) along with therapeutic rationale and justification for Phase III clinical trial waiver and BE study protocol before the committee.
Arsenic trioxide is a chemotherapeutic agent used in the treatment of refractory or relapsed acute promyelocytic leukaemia in patients with prior retinoid and anthracycline chemotherapy.
Arsenic trioxide is a chemotherapeutic agent of idiopathic function used to treat leukemia that is unresponsive to first-line agents. It is suspected that arsenic trisulfide induces cancer cells to undergo apoptosis. In general, arsenic is known to be a naturally toxic substance capable of eliciting a variety of dangerous adverse effects. The enzyme thioredoxin reductase has recently been identified as a target for arsenic trioxide.
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