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Qdossier Qsauri
"B"

biological medicinal product
Definition
A biological medicinal product is a medicinal product whose active substance is made by or derived from a living organism. Encompass most drugs whose manufacture involves purification from biological sources such as human or animal tissue or body fluids, or micro-organisms, including those derived using biotechnology. Typical examples include blood and blood products, vaccines, biological response modifiers (growth factors, cytokines, etc.) protein hormones, gene therapy vectors, and cell-based products. Biologics can consist of any virus, therapeutic serum, toxin, ntitoxin, or analogous product used in the prevention, treatment or cure of diseases or injuries in humans. Biologics make up one large category of drugs; the other major category of drugs is pharmaceuticals, or synthetic drugs made from chemicals.
Used For
biologic product
biological
biological drug
large molecule drug
Broader Term
medicinal product
Narrower Term
blood product
gene-therapy medicine
Related Term
biologic active pharmaceutical ingredient
biologics license application
biosimilar medicinal product
biotechnology
parent organism
 

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