Microsampling in Early Phase Drug Development

Overview


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Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic drugs, metabolites, and biomarkers in preclinical and clinical research. In preclinical research, microsampling technology supports the 3Rs of animal research, and allows for less intrusive blood collection procedures. This document is intended to analyze the impact and considerations for a successful microsampling approach.

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In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs), including: a review of the relevant guidance HPAPI classification systems safety processes...

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