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... Usually convert the parent drug to a more polar metabolite by introducing a functional group (OH, -NH2, -SH). Phase I metabolism may increase, decrease, activate (prodrug, e.g. enalapril) or leave unaltered the drug’s pharmacologic activity. Phase I reactions are catalyzed by the cytochrome P450 (CY ...
Generic legislation of new psychoactive drugs
Generic legislation of new psychoactive drugs

... as possible introduce generic legislation and invoke the precautionary principle to protect public health as a basis. According to these states, this procedure achieves the following goals: (1) fewer people come into contact with potentially harmful drugs, (2) legislature can timely intervene when n ...
Manuscript "Fast-track drug approval in inflammatory bowel diseases"
Manuscript "Fast-track drug approval in inflammatory bowel diseases"

... criteria for fast track review and what would the outcome have been if they had been subject to this process This is a very interesting question. The following statement was added in our manuscript. “An interesting question would be whether the currently -or soon to be- approved IBD drugs would have ...
The Complexity of Herb-Drug Interaction Research
The Complexity of Herb-Drug Interaction Research

... Indinavir is metabolised mainly by CYP3A4. So golden seal may increase the effects of indinavir? Golden seal had no effect on drug levels of indinavir in a clinical study6 with volunteers.§ Example 3: Herb-Drug Interaction? – Some but not all Trials controlled for the dosage† Midazolam, alprazolam a ...
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Chapter 36 Drugs for Viral Infections HIV-AIDS

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Medication Alternatives for the Elderly

... This document serves as a guide and may not apply to all patients and all clinical situations and is based on information from the following sources: 1. Beers MH. Explicit criteria for determining potentially inappropriate medication use by the elderly: an update. Arch Intern Med. 1997;157:1531-6. 2 ...
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... responsibility to protect the public health and wellbeing from products that present risk of injury or gross deception or are otherwise deceptive. The nature and extent of risk shall also in accordance with implementing product recall classification. BFAD’s responsibility in product recall BFAD shal ...
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Orphan drug

An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity periods, all intended to encourage the development of drugs which might otherwise lack a sufficient profit motive. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development.According to Thomson Reuters in their 2012 publication ""The Economic Power of Orphan Drugs"", there has been increased investing in orphan drug Research and Development partly due to the U. S. Orphan Drug Act (ODA) 1983 and similar Acts in other regions of the world and also driven by ""high-profile philanthropic funding."" The period between 2001 to 2011 was the ""most productive period in the history of orphan drug development, in terms of average annual orphan drug designations and orphan drug approvals."" For the same decade the compound annual growth rate (CAGR) of the orphan drugs was an ""impressive 25.8 percent, compared to only 20.1 percent for a matched control group of non-orphan drugs."" By 2012 the market for orphan drugs was worth USD$637 million compared to the USD$638 million matched control group of non-orphan drugs, Thomson Reuters.By 2012, ""the revenue-generating potential of orphan drugs [was] as great as for non-orphan drugs, even though patient populations for rare diseases are significantly smaller. Moreover, we suggest that orphan drugs have greater profitability when considered in the full context of developmental drivers including government financial incentives, smaller clinical trial sizes, shorter clinical trial times and higher rates of regulatory success.""
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