MFDS Issues Detailed Guidance on Drug Development Bioanalytical Methods
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| Bioanalytical Method Validation |
NIFDS Releases Guidelines for Reliable Bioanalytical Methods in Drug Development
On July 23, 2024, the National Institute of Food and Drug Safety Evaluation (NIFDS) published guidelines and a Q&A document on bioanalytical method validation and sample analysis for drug development. These guidelines aim to ensure the reliability of bioanalytical methods by reflecting international standards (ICH M10).
Key Points:
• Bioanalytical Method Validation: Provides methods for evaluating parameters such as accuracy, precision, specificity, recovery, linearity, range, and stability.
• Sample Analysis: Outlines procedures for conducting sample analysis based on the results of bioanalytical method validation.
• Q&A: Addresses frequently asked questions (FAQs) that arose during the development of the guidelines.
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