What is Optimal Dosing of Psychotropic Drugs?
It is generally assumed that the Physicians’ Desk Reference1 provided adequate guidance on the optimal dosing of psychiatric medications. After all, the package insert includes a recommended starting dose, therapeutic dose, and maximum recommended dose. However, the guidance provided by the PDR is based on New Drug Applications submitted by pharmaceutical companies. That submission typically includes the studies, including phase III trials that lead to Food and Drug Administration approval.2,3 The FDA does not usually require optimal dosing studies. Optimal dosing might be defined as the dose that provides the greatest benefit with the least harm. Rather, the FDA only requires demonstration that the drug is effective and reasonably safe at a specific dose for the condition in which it will be indicated. It is generally both impractical and prohibitively expensive for a pharmaceutical company to test a very wide range of doses for a specific indication. Therefore, it is conceivable that
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