title: Safety considerations in product development.
abstract: In drug development, about 1 in 1000 interesting compounds reaches the market. Drug safety is only relative and needs to be considered in the context of efficacy. Ultimately, the standards of safety and efficacy are determined by society. Drug safety can be enhanced by adequate patient education, i.e. patients should understand their disease as well as the risks and benefits of their medication. There is often considerable public pressure on the Government and regulatory authorities to alter some aspects of the drug development process. While we should not engage in poor science or alter regulations unthinkingly, the process should be re-examined and re-evaluated as the usual methods of evaluating risk/benefit may not be suitable for a particular disease or patient population. Public pressure has influenced changes in the USA, such as the parallel track testing, early release of drugs etc. It is important to realise that absolute toxicity is rare. Relative toxicity is more usual but may be influenced by many factors such as disease processes, drug dose, duration of administration, kinetic parameters or immunological factors. Clinical considerations in the drug development process include the predictability of adverse reactions in some patient populations, problems of over-dosage, unexpected drug-drug interactions and availability of patient monitoring. Economic factors such as total cost of the drug regimen, availability of alternative therapies, expense of sponsor-initiated special studies and surveillance, liability risk and the potential cost of altered labelling, warning notices and even market withdrawal are also considered. Thus, there are general guidelines, but the clinical, safety and toxicity considerations involved in the development of each drug may be special or unique.
authors.affiliation: EM Pharmaceuticals Inc., Hawthorne, New York, New York.
authors.forename: A H
authors.initials: AH
authors.lastname: Hayes
mesh_terms: D015195:Drug Design; D004345:Drug Industry / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug / Q000639:trends; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration