GMP Production and Extended Toxicology of an Oral Formulation Drug for Alzheimer's Disease

Northwestern University At Chicago, Evanston IL

Investigators

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Abstract

ABSTRACT This is an administrative supplement application to U01 AG076480, to request costs due to unforeseen circumstances. These additional proposed activities are within the scope of the U01 project but were unexpected at the time of award. For example, the length and breadth of the COVID-19 pandemic were not anticipated by public health or other government agencies. The pandemic caused several downstream hurdles, including scheduling delays with CROs, supply chain shortages, and dramatic cost increases. The effect was profound for the GMP drug manufacturing and testing (aim 1) and the extended GLP toxicology studies (aim 2). Therefore, we are requesting an administrative supplement to allow us to complete the specific aims and meet the milestones of our AG076480.