My mom― a clinician scientist herself― would often say this about the power of pharmacology: Every medicine has its price. While most patients benefit from their medications, cases of fatal drug poisonings are tragedies wherein patients pay the ultimate price. Forensic toxicology probes cases of fatal poisonings where the cause of death is unknown. This … Continued
Month: September 2016
The new blockbuster: well-defined patient populations bring efficiency to drug development and higher commercial value to precision drugs (labels).
EMA Policy 70 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. In March 2016, the detailed guidance document was published. This blog post … Continued
PRINCETON, NJ – Sept. 22, 2016 – Certara today announced that the first Certara Biomedical Research Scholarship has been awarded to the National Institutes of Health (NIH) National Center for Advancing Translational Science (NCATS) on behalf of postgraduate oncology research student David Morse, MPhil, and the research he is conducting in the laboratory of Craig Thomas, PhD.
Scientists at the Aarhus University in Denmark used the Simcyp Simulator to support a forensic toxicological assessment of a fatal drug poisoning case.