A recombinant vaccine in clinical grade is manufactured for the purpose of its clinical trial starting from Preclinical/Tox to Phase IV.
1. If vaccine is a covid vaccine & manufactured using cell culture, then what kind of bioreactors can be used with list of probable process equipments & short process flow?
2. What stages of QC/IPQC tests are required before for each phase of clinical trial?
3. Purpose or outcome of each phase of clinical trials with expected numbers of subjects needed for the trial in each clinical trial phase.
4. Which States & Central agencies need to be approached during clinical trial? What is the purpose of getting FORM-29 & FORM 28D?
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A recombinant vaccine in clinical grade
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