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The long road of biopharmaceutical drug development: from inception to marketing
QJM: An International Journal of Medicine, 10/26/09
Mundae MK et al. – The development of therapeutics is costly, time–consuming and has high attrition rates. Biopharmaceutical medications differ from traditional agents in their discovery, design, structure and formulation. Prior to marketing a drug must show efficacy and acceptable toxicity in both preclinical and clinical trials. Regulatory bodies have a pivotal role in the licensing, naming and marketing of an agent.
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