Healthy Skepticism Library item: 16667

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Mundae MK, Ostor AJ.
The long road of biopharmaceutical drug development: from inception to marketing.
QJM 2009 Oct 21;
http://www.ncbi.nlm.nih.gov/pubmed/19846578

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.