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Merck Sharp & Dohme - Articles and news items

Results of Phase 2 study of lonafarnib in HDV infected patients published

Industry news / 20 July 2015 / Victoria White

Results of the first Phase 2a study of lonafarnib in patients with chronic hepatitis delta virus (HDV) infection have been published…

Atezolizumab

Syndax and Merck to collaborate on immuno-oncology study evaluating entinostat in combination with Keytruda in lung cancer and melanoma

Industry news / 31 March 2015 / Victoria White

Syndax and Merck have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining entinostat with Keytruda (pembrolizumab)…

Raw material identity verification in the pharmaceutical industry

Identification & Verification, Issue 3 2013 / 13 June 2013 / Bülent Üstün, Senior Scientist, Merck Sharp & Dohme

Inspection of incoming raw materials is an essential step in the pharmaceutical industry to verify that the correct raw material which meets the quality specifications has been received. It will not only help to ensure that the final product is of best quality and minimise wasted time, material costs and delayed shipment if specifications are not being met, but also maintain safety. The presence of an incorrect material in a manufacturing process could compromise safety. For this reason, at least one test to verify the identity of incoming raw materials should be conducted before use (as required by regulatory authorities).

Figure 1 High content screening analysis of HepG2 cells stained under control (A,C,E,G), or 24 (B,D,F) and 72 (H) h incubations with 10-6 / 10-5 M doxorubicin with different fluorescent probes, i.e.. Hoechst 33342, Fluo-4, TOTO-3 and TMRM

High Content Screening for in vitro toxicity testing

Issue 3 2011, Screening / 20 June 2011 / Willem G.E.J. Schoonen, Walter M.A. Westerink, Femke M. van de Water and G. Jean Horbach, Department of Toxicology & Drug Disposition, Merck Sharp & Dohme

The application of High Content Screening for in vitro toxicity testing is a relatively new approach in the preclinical research phase of drug development. A battery of tests have been developed for screening on general parameters such as cytotoxicity, while more dedicated assays are available with respect to the identification of genotoxicity, phospholipidosis, steatosis and cholestasis. All these tests are very beneficial within the pharmaceutical industry for the selection of appropriate candidates for drug development as well as for reduction of the attrition rate.

High content screening (HCS) is quickly growing in popularity within the field of in vitro toxicity testing. The maturity of HCS equipment and software has made HCS accessible for many technicians and scientists working in the area of cellular and molecular biology. Although this technique was introduced in the mid 1990’s, the simplification in the use of the software programs, the growth in computer storage capacities as well as the improved qualities of resolution of the digital microscopic cameras has largely increased the accessibility of this equipment. At the start of HCS technology, many scientists were sceptical about this technique as image-based mathematical algorithms had to be written for the analysis.

Next Generation Drug Development Summit: Imaging Biomarkers

Industry news / 9 November 2010 / NG Online News

Senior executives from Eli Lilly, AstraZeneca, Johnson and Johnson & Pfizer to discuss the ROI for “non-surrogate” biomarkers, dose selection biomarkers and biomarkers of efficacy.

 

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