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Validation and application of volumetric absorptive microsampling (VAMS) dried blood method for phenylalanine measurement in patients with phenylketonuria

Lan Gao,Neil Smith,Diksha Kaushik,Sarah Milner,Ronald Kong

Clinical Biochemistry（2023）

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Abstract
•Volumetric absorptive microsampling (VAMS) dried blood method for blood phenylalanine measurement.•Validation of bioanalytical method in compliance with regulatory guidance.•Correlation analysis of VAMS dried blood method with plasma method.•Application in clinical study to support primary efficacy endpoint.
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Phenylalanine (Phe), Dried blood spot (DBS) sampling, Volumetric absorptive microsampling (VAMS), Phenylketonuria (PKU), PTC923 (sepiapterin), Validation
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