The authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.
Smritie Sheth
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Smritie Sheth is scientific manager at SymphonyTech Biologics.
Articles by Smritie Sheth
A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
Amid the rush for a SARS-CoV-2 vaccine to deal with the COVID-19 pandemic, a robust risk assessment must be conducted, and mitigation strategies applied.
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