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Rapid Development and Clinical Assessment of New Rectal and Oral Formulations for Ulcerative Colitis Using Real-Time Adaptive GMP Manufacturing and Supply

TOP1288 is a non-systemic kinase inhibitor (NSKI) being developed as a treatment for patients with ulcerative colitis. As a novel, locally-acting candidate, TOP1288 has low systemic bioavailability and therefore a dual-pronged formulation strategy was adopted with rectal and oral formulations being developed.

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