How PBPK Can Help Solve Fatal Poisonings

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

Best Practices for Complying with EMA Policy 70

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

Inaugural Certara Biomedical Research Scholarship Awarded by International Biomedical Research Alliance

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.