U.S. Food and Drug Administration Issues NIR Guidance
On August 6, 2021, the U.S. Food and Drug Administration (FDA) released final guidance regarding near-infrared (NIR) analytical procedures. The guidance applies to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small-molecule drugs. The FDA will address recommendations for NIR methods used in biologics under a future revision of the guidance.
The new 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 Harmonization 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.
Best of the Week: What You Missed from Pittcon and AAFS
March 14th 2025Top articles published this week include a video interview on the role of near-infrared (NIR) spectroscopy in food and bioanalysis, a recap of an important session at Pittcon, and a dynamic video that summarizes the highlights of the American Academy of Forensic Sciences (AAFS) Conference.
Raman Spectroscopy Aflatoxin Detection Enhances Peanut Safety
March 11th 2025A research team from Jiangsu University has developed a Raman spectroscopy-based method to detect aflatoxin B1 (AFB1) in peanuts with improved accuracy and efficiency. By employing a two-step hybrid strategy integrating backward interval partial least squares (BiPLS) and variable combination population analysis (VCPA), the new model significantly enhances the precision of AFB1 detection, providing a more reliable approach for food safety monitoring.
Advancing NIR and Imaging Spectroscopy in Food and Bioanalysis
March 11th 2025Our full-length interview with Huck covers more than just NIR spectroscopy in food and bio analysis. Spectroscopy sat down with Huck to also discuss current trends going on in spectroscopy, delving into what challenges spectroscopists face today and how they can solve these concerns.
