Predicting Drug Safety: Next Generation Solutions

Johnson, Dale E.

doi:10.4172/2157-7609.1000e106

Cited by 3 publications

(1 citation statement)

References 17 publications

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“…In fact, the frequency at which drug products are recalled post-market for safety reasons despite extensive pre-market research and clinical testing exemplifies some of the limitations on pre-market safety assessments. Several studies have been conducted to demonstrate this point, and in 2001, a retrospective review of 150 drug withdrawals revealed the most frequent safety reasons for removal from the market of which included several serious concerns such as hepatotoxicity (27.9 %), cardiovascular toxicity (17.4 %), nephrotoxicity (5.6 %), neurotoxicity (6.3 %) and carcinogenicity (6.3 %) [ 11 , 13 ].…”

Section: Supplier Compliancementioning

confidence: 99%

A quality dietary supplement: before you start and after it’s marketed—a conference report

LeDoux¹,

Appelhans²,

Braun

et al. 2015

Eur J Nutr

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Consumers worldwide are turning to dietary supplements as one part of their personal goal to lead healthier and more active lives. In truth, the quality of life now supersedes the length of life as no one would trade living to one hundred (the last forty with compromised physical abilities and decreased mental acuity) for 80 years of travel, time with family, and intellectual pursuits. If there is the possibility of preventing a disease or debilitating condition through efficient lifestyle changes (additions, subtractions, modifications) and to also avoid the costly and escalating medical and pharmaceutical treatments that accompany having the disease/condition, then a sensible individual would focus on their overall health and wellness…proactively, instead of reactively. However, an important caveat is that over-regulation or inappropriate application of current regulations can increase the price of dietary supplements and nutritional products and thus cause underutilization of the potentially beneficial physiological attributes of these products. Conversely, strict adherence to regulatory guidelines could result in safer dietary supplements and fewer adverse reactions requiring medical attention. If new regulations or stricter interpretation/application of existing regulations result in certain dietary supplements being taken off the market, will continued demand create a completely unregulated, underground economy that will create unforeseen problems? More research should be supported by government agencies to determine the effectiveness of dietary supplements, nutritional products and complementary medicine in reducing personal and societal medical costs and further contribution to the overall health of the population.

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Section: Supplier Compliancementioning

confidence: 99%