ICH Q6B for Analytics.

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معلومة اضافية
- الموضوع:
  Pharmacology; Proteins; Liquid chromatography-mass spectrometry; Biological products; New product development; Pharmaceutical industry; Monoclonal antibodies; Molecular structure; Amino acids; Biosimilars
- نبذة مختصرة :
  The article focuses on the ICH Q6B guidelines for the analytical testing of biotechnological products, including specifications for product quality, analytical method validation, and regulatory compliance to ensure consistent safety and efficacy.