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Indian Draft Regulatory Guidelines For The Development Of Vaccines Following Covid-19 Pandemic.

These guidelines specify that vaccines stay stable at required storage settings for a clinical trial period at the time of the clinical development stage and throughout the shelf life after approval. Sufficient toxicity data and immunogenicity in reference of humoral and cell-mediated immune responses are created in some non-clinical studies in some relevant animal models.
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Indian Draft Regulatory Guidelines For The Development Of Vaccines Following Covid-19 Pandemic.

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