lower limit of quantification

[timbrisc]

Issue migrated from trac ticket # 5821

component: organization | priority: minor | keywords: LLOQ

2022-06-07 20:41:30: william.hess@fda.hhs.gov created the issue

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UCUM Board needs to provide input on this. UCUM already has "Limit of flocculation" so adding a UCUM term called "lower limit of quantification" would be somewhat consistent. Limit of quantification, LOQ stands for the smallest amount or the lowest concentration of a substance that is possible to be determined by means of a given analytical procedure with the established accuracy, precision, and uncertainty. Please see https://www.sciencedirect.com/topics/nursing-and-health-professions/limit-of-quantitation#:~:text=Limit%20of%20quantification%2C%20LOQ%20stands,accuracy%2C%20precision%2C%20and%20uncertainty.

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."

[dr-shorthair]

This concept is not a unit-of-measure, it is a quality measure or part of the definition of a measurement-procedure.