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QJM Advance Access published online on October 21, 2009
QJM, doi:10.1093/qjmed/hcp145
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© The Author 2009. Published by Oxford University Press on behalf of the Association of Physicians. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

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

M.K. Mundae and A.J.K. Östör

From the Rheumatology Research Unit, Addenbrookes Hospital, Hills Road, Cambridge, CB2 2QQ, UK

Address correspondence to M.K. Mundae, Rheumatology Research Unit, Addenbrookes Hospital, Hills Road, Cambridge, CB2 2QQ, UK. email: maninderkmundae{at}googlemail.com, maninder.mundae{at}googlemail.com


  Abstract

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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