Industry-leading rubber and plastics expertise - from product concept to launch and beyond
The worldwide authority on the packaging, paper and print industry supply chains
Providing business solutions in the areas of environmental and consumer safety through knowledge and technology
Provides events, market reports and strategic consultancy to niche, emerging and high-growth industries
Accredited quality, environmental and safety management systems certification body serving industrial, commercial, government and service businesses
Contract research organization with expertise in large molecule bioanalysis supporting pharmaceutical discovery through phase IV clinical trials and offering preclinical toxicology and vaccine testing
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.
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.