Demystifying the ICH M10 Bioanalytical Method Validation Guidelines
Conversations in Drug Development Trends
APRIL 4, 2024
Stability Tests: For small molecule, only -20°C stability testing is required, while large molecule need both -20°C and -70°C tests if samples are intended for storage at these temperatures. Quality Control Batches : These batches are utilized to ensure the assay’s accuracy when measuring various study samples.
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