NATIONAL | Sept 16, 2020: Serum Institute of India (SII) para Tuesday din te Drugs Controller General of India (DCGI) V G Somani para permission paishe Oxford COVID-19 vaccine laga clinical trials desh te shuru kuribole nimete.
Hoilebi DGCI para etu order toh revoke kura pichede nutun recruitment lobole nimete phase 2 aro 3 trials nimete tai khan para kunba conditions khan dhalishe kuntu toh kara para chulabole nimete pharmaceutical company khan kuribole nimete.
Trial phase te firm ke koishe conditions khan follow kuribole nimete etu te screening samay te care kuribole nimete additional information dibole nimete consent te aro adverse events khan sabole nimete study laga followe up kura te .
SII ke aro bi koishe DCGI’s office ke details khan dibole nimete medication chula toh management laga protocols chula hisaab te adverse events nimete.
Etu firm kun tu toh UK based company AstraZeneca logote milishe etu vaccine candidate bonabole nimete COVID-19 karne olop akhe te vaccine laga clinical trials rukhaishe desh te DGCI para kuwa pichede.
unexplained illness early study te ola nimete study participant te UK, AstraZeneca te global trials rukhaidishe experimental coronavirus vaccine nimete.Etu bi DGCI para SII ke koishe etu india te etu vaccine laga clinical trial phase toh rukhidiya pichede.
Saturday te AstraZeneca and the University of Oxford koishe clinical trials tai khan laga coronavirus vaccine nimete uk te shuru kurishe etu bi Medicines Health Regulatory Authority’s (MHRA) para etu trials toh safe ase koiekena janaa pichede.
DGCI para aro bi SII ke koishe Data Safety Monitoring Boards (DSMB) of India and the UK le approval mangishe etu COVID-19 vaccine trial shuru kuribole nimete.
Tuesday te SII para recommendation dishe DMSB of India and the UK laga aro permission mangishe clinical trials laga enrolment shuru kuribole nimete.
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