The long road of biopharmaceutical drug development: from inception to marketing

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 cli...

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Bibliographic Details
Published in:QJM : An International Journal of Medicine 2010-01, Vol.103 (1), p.3-7
Main Authors: Mundae, M.K., Östör, A.J.K.
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal - therapeutic use
Biological and medical sciences
Clinical Trials as Topic - legislation & jurisprudence
Drug Design
General aspects
Humans
Marketing - legislation & jurisprudence
Medical sciences
Research Design
Terminology as Topic
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Summary: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.
ISSN:1460-2725
1460-2393
DOI:10.1093/qjmed/hcp145