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Analytical Validation

View Resource (HTM)

Category

Document

Published on CMKC

Abstract

Guideline establishes the requirements for validationg analytical methods, ensuring consistency in the routeine measurements of pharmaceutical products and their intermediates.

Journal

ICH Q2

Type of publication

Document

Affiliations

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Article Classification

Guideline

Classification Areas

  • Regulatory

Tags

  1. Detection Limit / Quantitation Limit
  2. Guideline
  3. Linearity
  4. Precision / Accuracy
  5. Range
  6. regulatory
  7. Robustness
  8. Specificity