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Insulin is a peptide therapeutic used to manage type 1 diabetes, which affects more than 20 million people worldwide according to the international diabetes federation. a significant limitation to the broad distribution and use of insulin to treat type 1 diabetes is the fact that it must be administered by injection rather than orally. why is insulin administered by injection and not orally?

Adouble-blinded trial for a new indication is conducted under an ind comparing two (2) marketed drugs, at twice the approved prescribed doses. on day 2, subject 603 had difficulty breathing. although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. on day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. these episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. the investigator would submit an sae report for

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