As we learned in the eCTD series of posts, the implementation of the standard by the FDA includes a series of technical specifications which define the format of an application and its sections. The latest technical specification, Bioanalytical Methods Templates, gives sponsors a tables format for submitting summary information on the bioanalytical methods used for clinical pharmacology studies. These tables are intended for inclusion in the appendices of the Summaries of Biopharmaceutics in eCTD section 2.7.1. The templates are part of the FDA data standards, and the latest updates may be found on the data standards web page.
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