component: organization | priority: minor | keywords: EC50
2022-06-07 19:59:25: william.hess@fda.hhs.gov created the issue
UCUM already has "50% cell culture infectious dose", "50% embryo infectious dose", and "50% tissue culture infectious dose", so it would be reasonable for the UCUM Board to also consider "50% effective concentration" which is defined as, "The concentration of a drug that gives half-maximal response" (https://www.graphpad.com/support/faq/50-of-what-how-exactly-are-ic50-and-ec50-defined/).
This new concept is needed to support the U.S. Food and Drug Administration Pharmaceutical Quality Chemistry Manufacturing and Control (PQ/CMC) initiative. Please see https://www.regulations.gov/document/FDA-2022-N-0297-0001, which in part, states:
"PQ/CMC is a term used to describe manufacturing and testing data of pharmaceutical products. PQ/CMC encompasses topics such as drug stability, quality specification, batch formula, and batch analysis, which are important aspects of drug development. PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products. The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data submitted, thus providing a harmonized language for submission content, allowing reviewers to query the data, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating a standardized data dictionary.
The impetus for this standardization effort was the provisions from the 2012 Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), which authorized the Agency to require certain submissions to be submitted in a specified electronic format. PQ/CMC standardization supports FDA's regulatory needs in receiving structured and standardized data in pharmaceutical quality and includes two objectives: (1) To standardize the pharmaceutical quality data that is currently received by FDA in eCTD Module 3 from the sponsoring organizations, and (2) to use these structured elements and develop a FHIR data exchange solution."
timbrisc
commented
2 years ago
Issue migrated from trac ticket # 5811
component: organization | priority: minor | keywords: EC50
2022-06-07 19:59:25: william.hess@fda.hhs.gov created the issue