Narendra Chirmule

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.

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.

Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.