Browsing: Regulated bioanalysis

gcc-feedback
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Stephanie Cape (Covance) gives her thoughts on the GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline in this interview with Bioanalysis Zone.

gcc-feedback
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Chad Briscoe (PRA) gives his thoughts on the GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline in this interview with Bioanalysis Zone.

regulation guidelines
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Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. This perspective piece highlights three tiers of method validation – regulatory, scientific and research validations. The criteria for selecting the appropriate application of each of these PK method validation workflows are discussed.

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