WHITE PAPER: Bioanalytical Quantitative Determination Of Pegylated Species In Human Plasma By NMR

Innovative bioanalytical methods supporting preclinical / clinical bioanalytical studies such as PEG clearance studies

Bioanalysis plays a critical role in the assessment of drug safety and efficacy. With increasingly complex drug substances in clinical development and equally complex clinical matrices, there is a need for innovative approaches towards robust bioanalytical methods that are suitable for supporting both preclinical and clinical bioanalytical studies whilst meeting the requirements of Bioanalytical Method validation guidelines.

In this White Paper, our bioanalysis experts illustrate how innovative approaches such as Nuclear Magnetic Resonance Spectroscopy (NMR), a non-typical bioanalytical technique, can be applied to quantification of PEGylated molecules in clinical matrices. The following article describes how our GLP/ GCP compliant Total Quality Assurance laboratories have successfully validated bioanalytical methods to quantify PEGylated compounds across a diverse set of biological matrices and species. The use of NMR has overcome many challenges experienced with conventional bioanalytical techniques during PEG clearance studies.

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