Nitrite analysis of excipients is a new and analytically challenging area, with many organisations working quickly to determine the best practice and techniques to use.
The Nitrites in Excipients data sharing consortium was established in September 2020 and is part of Lhasa Limited's effort to support the global challenge of nitrosamine risk assessment.
A provision for the application of ‘expert knowledge’ is mentioned within the ICH M7 guideline. However, as (Q)SAR models continue to be updated and their predictive performance and structural coverage improves, this raises the question of whether expert review is still necessary…
A provision for the application of ‘expert knowledge’ is mentioned within the ICH M7 guideline. However, as (Q)SAR models continue to be updated and their predictive performance and structural coverage improves, this raises the question of whether expert review is still necessary…
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