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 clinical trials. Regulatory bodies have a pivotal role in the licensing, naming and marketing of an agent.
Addenbrookes Hospital, Cambridge, CB2 2QQ, UK. maninderkmundae@googlemail.com
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D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D015195:Drug Design; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence; D012107:Research Design; D009626:Terminology as Topic
D000911:Antibodies, Monoclonal