Opened 3 weeks ago

Last modified 3 weeks ago

#5818 new enhancement

limit of detection

Reported by: William Hess Owned by:
Priority: minor Milestone:
Component: organization Keywords: LOD
Cc:

Description (last modified by William Hess)

UCUM Board needs to provide input on this. UCUM already has "Limit of flocculation" so adding a UCUM term called "limit of detection" would be somewhat consistent. Limit of detection, LOD is the lowest concentration that can be measured (detected) with statistical significance by means of a given analytical procedure.20 It is a measured quantity value, obtained by a given measurement procedure, for which the probability of falsely claiming the absence of a component in a material is β, given a probability α of falsely claiming its presence.1 Practically, it is determined on the basis of the noise level: it is most often three times as high. 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."

Change History (1)

comment:1 Changed 3 weeks ago by William Hess

Description: modified (diff)
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