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While only two drug-eluting coronary stents are currently cleared for sale in the U.S., numerous others are peeking over the horizon, awaiting their turn in the sun. The existing products and those that are on the way reflect a variety of different approaches in terms of both the drugs and the polymer coatings chosen by the companies vying for a spot in the marketplace.
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There currently exists much evidence to direct the application of Noninvasive Positive Pressure Ventilation (NPPV). NPPV for the treatment of patients with acute respiratory failure has generated several meta-analyses and systematic reviews,1-4 including a recent one by Dean R. Hess PhD, RRT.
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In patients with acute lung injury or ARDS, the addition of higher PEEP levels to the strategy of a low tidal volume does not improve clinical outcomes.
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Hypothyroidism and Pregnancy; Anti-Depressants and the Risk of Suicide; FDA Actions; Brief Notes.
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When the general public pictures genetic research, they think of new screening tests to detect rare diseases, or they think of cutting-edge gene therapy experiments that have the potential to completely reverse a previously fatal condition. However, the real promise of genetic knowledge, say many experts, is in the potential to target drug therapy for common diseases, such as heart disease and cancer, that affect huge numbers of people.
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In this issue, Clinical Trials Administrator begins with this issue a periodic series on clinical trials software, looking at its use, potential, and availability. The software featured in this issue is eCTM, created by CyberMedica Foundation of Kennebunkport, ME.
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Pharmaceutical companies conducting clinical trials in the United States tend to focus their regulatory attention solely on the requirements imposed by the FDA. This can be a mistake. Focusing on FDA regulations to the exclusion of state regulatory requirements may put the sponsor at risk. A large and increasing number of state requirements apply to clinical trials.
