Question:

Which guideline is commonly referred to for method validation in pharmaceutical analysis?

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ICH Q2 (R1) is the go-to guideline for validating analytical methods in pharmaceutical settings.
Updated On: Jun 16, 2025
  • ICH Q3A
  • ICH Q2 (R1)
  • ICH Q1B
  • ICH Q4A
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The Correct Option is B

Solution and Explanation

The ICH Q2 (R1) guideline is the internationally accepted standard for method validation in pharmaceutical analysis. It outlines parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, and robustness.
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