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Bioanalytical Challenge of Measuring Highly Protein Bound Drugs and Protein Binding Measurement under Regulatory Environment
on Mar 2, 2017 12:00 PM EST at:
The determination of drug–protein binding is important in the pharmaceutical development process because of the impact of protein binding on both the pharmacokinetics and pharmacodynamics of drugs. In the body, only unbound drug can pass through most cell membranes and equilibrate with the extravascular space and only unbound drug molecules circulating in plasma or blood are available for interacting with target receptors
or enzymes. In addition, unbound drug is important in the prediction of pharmacological effect, volume of distribution, drug-drug interaction potential and safety margin assessment. Recently, there is also an increasing regulatory expectation for the quantitative determination of the unbound (fu) value. Highly protein bound drug measurement can pose unique challenge
s, sometimes, the slight changes in the unbound value may be clinical relevant. Therefore, developing a solid and sensitive bioanalytical assay for highly protein bound drugs can be critical for patient data interpretation. In this presentation, we will go over practical and regulatory considerations in protein bound drug measurement, techniques for unbound drug (fu) measurement and challenges in measuring highly protein bound compound.
Xiaonan Tang, PhD
Associate Director, Bioanalytical department
Frontage Laboratories, Inc
Drug-protein binding is important for the understanding of the drug metabolism and the drug’s efficiency because only the unbound fraction exhibits pharmacologic effect. Accurate measurement of the fraction unbound therefore is critical and the requirement of measuring the fraction unbound in plasma samples has been increasing. This presentation starts with a brief introduction and comparison of the methodology for protein binding determination and the typical procedures for protein-binding measurement will be presented and compared followed by discussions on method validation from the regulatory perspectives.
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