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"Efficacy and tolerability of tirzepatide, a dual glucose-dependent insulinotropic peptide and glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes: A 12-week, randomized, double-blind, placebo-controlled study to evaluate different dose-escalation regimens"

doi:10.1007/s40262-017-0532-6 160

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If passed, these requirements would shift cGMP compliance for 503B facilities operating at scale from an episodic enforcement matter into a gatekeeper for whether new drugs can be compounded at all