A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
Frank Diana
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Articles by Frank Diana
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
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Latest Updated Articles
Early Development GMPs for Stability (Part IV)Published: September 2nd 2012 | Updated:
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachPublished: October 2nd 2014 | Updated:
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