Drug development history, "overview," and what are GCPs?
History shows that regulation of the pharmaceutical industry came about as a result of unfortunate incidences in which self-control by the industry was insufficient. All facets of drug manufacturing and preclinical laboratory research and development are regulated by GMPs and GLPs. Only part of the GCPs, as proposed, have become regulations. The pharmaceutical industry has an attrition rate of NCEs, from discovery to product, of 10,000 : 2. Research and development to market a product consumes 12 years (approximately 71% of patent life) and costs more than +250 million. The industry will be well served to closely monitor itself through conformance to GCP guidelines and regulations to avoid further government regulation.
Heilman
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RD
Pharmaco LSR, Inc. Austin, Texas 78704, USA.
D002986:Clinical Trials as Topic / Q000592:standards; D017277:Drug Approval / Q000266:history*; D004345:Drug Industry / Q000592:standards; D049672:History, 19th Century; D049673:History, 20th Century; D007880:Legislation, Drug / Q000266:history; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history*