Abstract:Clinical testing is not the only way to discover drug effects on people. That is the reason controlled clinical trials are the only legal basis for central regulatory agencies in each country, such as FDA, to conclude that a new drug has clinical effectiveness for a drug or biologic. Before clinical testing begins, researchers analyze the drug's main physical and chemical properties in the laboratory and study its pharmacological and toxic effects in laboratory animals. On the other hand, bioequivalence studie… Show more
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