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FDA was prepared to rely on limited animal studies involving routes that did not align with many of the proposed compounded preparations, while assigning far less weight to existing human use, clinical records, practitioner experience, compounding history, and the absence of a clear adverse-event framework described by public commenters
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However, exocrine pancreatic insufficiency should be ruled out before biopsy, because signs of malabsorption are nonspecific and not easily differentiated from maldigestive disorders.10, 11 Thus serum trypsin-like immunoreactivity (TLI) measurement must be performed in all cases (see Chapters 25 and 60Chapter 25Chapter 60)