Mukesh Ambani Kovid 19 vaccine: Reliance Life Sciences gets regulatory approval for 2-dose vaccine tests – Drug Regulatory Authority approves Reliance Life Sciences for clinical trials of 2-dose corona vaccine.
- The purpose of determining the maximum tolerability (MTD) of clinical trials in the first phase is to obtain reliable information on safety, tolerability, pharmacokinetics (PK) and mechanism of action of the vaccine.
- The first phase tests are usually taken to test the strength of the dose tolerated for 58 days.
- Upon completion, the company may apply for Phase-2/3 tests.
The Drug Regulatory Authority of India has approved Reliance Life Sciences for clinical trials of 2-dose corona vaccine (Covid 19 vaccine). Reliance Life Sciences’ Covid 1V vaccine is a candidate recombinant protein based vaccine. Reliance Life Sciences is a part of Reliance Industries.
Reliance Life Science’s application was reviewed and approved at the Subject Expert Committee (SEC) meeting on Thursday. Sources told ET that Reliance had approached the drug regulator for testing the first phase of its proposed two-dose vaccine.
What is known in Phase-1 tests
The purpose of determining the maximum tolerability (MTD) of clinical trials in the first phase is to obtain reliable information on safety, tolerability, pharmacokinetics (PK) and mechanism of action of the vaccine. One person says, “Phase-1 tests are usually taken for 58 days to test the strength of the tolerated dose. After this is completed, the company can apply for phase-2/3 tests.”
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