ICH Guidelines for API Stability: Q1A–Q1E and Q3C Explained
ICH Guidelines for API Stability: Q1A–Q1E and Q3C Explained ICH Guidelines for API Stability: Q1A–Q1E and Q3C Explained Introduction Stability Studies are a critical part of the pharmaceutical development lifecycle. For active pharmaceutical ingredients (APIs), ensuring the chemical, physical, and microbiological integrity of the drug substance over time is essential to patient safety and product…
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