FDA产品质量的风险评估原则翻译.pptVIP

* I say “re-link” because it is a given that the links were there historically. In general, there was a valid health and safety reason for each of the product GMPs. Promulgations of the standards was based on an analytic-deliberative process in risk assessment. What has happen is a loss of prioritized relevance to how drugs are manufactured today and with what we know about patient risks, today. * * * How well does risk analysis do in a democratic society? There are lots of risks “out there” and limited resources with which to manage them. There is simply no way to drive all risks to zero through resource allocation for risk management. Given this caveat, is there some order to the risks we—as a society—manage our health risks? Well, the way it “works” in contemporary democracy is that risk assessors, as the truth seekers, objectively line up the risks from the worst to the insignificant. (If you believe that risk assessment is entirely objective, you may be interested in some dot-com shares I’ve been saving for you!) For now, accept the argument, at least on relative terms. * The worst-to-best cases of risk are handed over to the risk managers for decision making about which ones to attend to first, particularly in terms of resource allocations. This is where the objective process gets tilted on its head: as a society, we have decided that subjectivity in terms of values, perceptions and our willingness to part with money, all can factor in to rearranging the objective ranking of risks. The logical extreme to this re-arrangement is evident in the full-blown precautionary principle: one doesn’t need any objective evidence of a risk to warrant mitigating the risk through hazard control. * Many risk analytical paradigms are available. Most have common feature, although the feature appear with different names. * Consequence assessment, a process that includes dose-response relationships, is part of antimicrobial resistance risk assessment for which the