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Subsequent chapters discuss the chemistry of oxygen radicals and other oxygen-derived species, protection against oxygen radicals and the superoxide theory of oxygen toxicity, and lipid peroxidation. Then there is a chapter on the chloroplasts of higher plants and the mammalian eye because these "very different systems have a lot in common." Finally, the authors include chapters on free radicals and toxicology, free radicals as useful species, and free radicals, aging and disease. As a researcher during this field at an outsized university, i'm frequently called upon by students, clinicians and other colleagues to assist them understand the topic of free radicals because they are interested in the field, or suspect that their field of research may involve free radicals. And until now there was no good introductory text on this subject. This book can serve this role. It is an easy hook to read with many anecdotes, editorial comments (perhaps the Vikings may have introduced the SOD-2 gene on one of their rampages!) and "examples of interesting biology which tend to stay the reader's interest. The book is not for those actively involved in research on the role of free radicals in biology and medicine.
In the United States, new medicines need to be approved by theFood and Drug Administration (FDA) as safe and effective. This process typically involves the application of a new investigationaldrug with sufficient preclinical data to support conducting ahuman clinical trial. After IND approval, three phases of largescalehuman clinical trials can be conducted in stages. Phase Iusually uses healthy volunteers to study toxicity. Phase II mayinvolve patient pharmacokinetics and medication and Phase IIIis a very large efficacy study in the target patient population.Upon successful completion of the Phase III test, the regulatoryagency submission will be submitted to the FDA. The FDAreviews the data and if the benefit risk assessment is positive, theproduct is approved in the US market. The fourth phase of postmarketingsurveillance is often required because even the largestclinical trials cannot effectively predict the prevalence of rareside effects. Post-marketing surveillance ensures that the safety ofa drug is closely monitored after it is put on the market.Indications may need to be limited to a specific patient group orthe substance may be completely withdrawn from the market.The FDA provides information on approved medicines on theorange book website. In the UK, the Medicines and HealthcareProducts Regulatory Agency (MHPRA) approves and evaluatesthe use of medicines. Approval in the UK and other Europeancountries is usually slower than approval in the United States.The UK and Wales National Health Technology AssessmentOrganization (WNHTAO) then decides if and how the UnitedKingdom National Health Service (NHS) permits their use. TheUK National Medicines Collection (NMC) is the primary guidefor pharmacists and clinicians. Many Western countries otherthan the United States have developed a "fourth hurdle" for costeffectivenessanalysis before introducing new technologies. Itfocuses on the "price of effectiveness" of the technology inquestion. In England and Wales, the NICE will determinewhether the NHS will make medicines and technologiesavailable and under what circumstances with the ScottishPharmaceutical Consortium of Scotland and the PharmaceuticalBenefits Advisory Board of Australia. The product must exceedthe profitability threshold for it to be approved. Treatment mustrepresent the "value of money" and the net benefit to society. 2b1af7f3a8