Smithers Avanza Resource Library

 

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Use of Two Technologies, Singulex Single Molecule Counting (SMC)™ and Meso Scale Discovery® (MSD) Technology For Drug Levels Determination of an Antibody Therapeutic, MK-A, in Human Serum in A Dose Escalation Study

 

MK-A is an immunomodulator molecule that is used in oncology treatments. Due to the unknown potential effects of the drug on immune system, the regulatory agency has advised to conduct dose escalation study starting with pg/mL. Singulex Erenna platform was used to address low sensitivity assay requirements, and higher drug concentrations were measured by the well-established MSD technology. The two PK (pharmacokinetic) methods were validated and bridged to demonstrate comparability using Cmax level dilutional control samples.

Featured Publication
Reproductive and Developmental Toxicity Testing

Examination of the Extended One-Generation Reproductive Toxicity Study Guideline
Authors:Shakil A Saghir, Ph.D. and Michael A Dorato, Ph.D.

This whitepaper discusses ways to make the EOGRTS guideline easier to follow; suggesting procedures to select relevant doses, and monitor the systemic exposure at different life stages for better interpretation of the data.