Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|August 9, 2021
- Pharmaceutical Technology's In the Lab eNewsletter, September 2021
- Volume 16
- Issue 09
FDA Issues NIR Guidance
Author(s)Pharmaceutical Technology Editors
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.
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On August 6, 2021, FDA released
The guidance provides the agency’s recommendations for the development, validation, and use of NIR-based analytical procedures in evaluating a drug product’s identity, strength, quality, purity, and potency. The recommendations address the application of concepts described in FDA and International Council for Harmonisation guidelines to NIR analytical procedures that use chemometric models. It also discusses submitting NIR documentation in applications.
The guidance does not discuss the development and validation of NIR analytical procedures or the setup, qualification, maintenance, or calibration of NIR instruments. The concepts of the guidance can be applied to other analytical technologies.
Source:
Articles in this issue
about 5 years ago
Enhanced Bioavailability of Acalabrutinib ASD Tablets In-Vivoabout 5 years ago
Biotium’s New Staining Kit Aims to Optimize Exosome Detectionabout 5 years ago
Next-Gen Automation Lab Aims to Speed Up Drug Discovery Processabout 5 years ago
BioAgilytix Acquires Australian-Based CRO 360biolabsabout 5 years ago
Todos Medical to Launch New Antibody Blood Test for COVID-19about 5 years ago
NIH Scientists Develop Faster COVID-19 TestAdvertisement
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