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  • CONTROLLED CLINICAL TRIALS As randomized, double-blinded, prospective, multiarmed clinical trials in humans have evolved over the past 20 years to become the “gold standard” for reducing unwanted biases and confounding (5), they have been classified by the FDA (7) and paraphrased by industry (3) into three phases for preapproval studies, and a fourth phase for additional studies after marketing viagra substitute nz. Initial introduction of the drug into humans, usually healthy volunteers or stable patients, to determine their tolerance to increasing doses, metabolism and pharmacokinetics, pharmacodynamic effects, and, particularly, safety of the drug in humans. But may also be done by academic investigators, this work is most often conducted by pharmaceutical companies. The process often takes from 4 to 8 years, from discovery to investigational new drug (IND) applications to approval of the new drug application (NDA), as outlined in Figure 1. 1.

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