Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics
Camargo
NOVEMBER 29, 2021
Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. Monoclonal antibodies (mAbs). PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.
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