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505(b)(2) – Part 2: The Assessment: Clinical Pharmacology

Clinical Pharmacology

An overview of the proposed product’s absorption, distribution, metabolism, and excretion (ADME) is detailed in this section obtained from various resources.  An important source of information for this and other sections is the FDA reviewer summaries (Summary Basis of Approval – SBA) for the reference listed drug (RLD) as well as other drugs in the therapeutic class. An example SBA is found here. Of course, should we be proposing to change the route of administration, it will be important to determine how this route may change the clinical pharmacology.  This information will drive the clinical studies that will be needed.


[1] PDR® Electronic LibraryTM [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.[2] Facts and Comparisons 4.0, Wolters Kluwer Health,