Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
One size does not fit all, reports Certara’s CEO, Edmundo Muniz, and in situations when pharmacokinetic data may be difficult or impossible to obtain, modeling and simulation will stand alone.
Read MoreModeling and simulation in drug development could change the commercial and regulatory landscape forever… and can deliver significant business, scientific and clinical value to companies.
Read MoreThe new blockbuster: well-defined patient populations bring efficiency to drug development and higher commercial value to precision drugs (labels).
Read MoreToday, drug development is carried out in human subjects and animals. However, as computing power and the number of sophisticated technology platforms grow exponentially, and our knowledge of human health and disease increases, the virtualization of clinical research and development will grow steadily.
Read MoreThe use of modeling and simulation (M&S) in drug development has evolved from being a research nicety to a regulatory necessity. This paper provides a compilation of best practices to systematically leverage the many benefits of M&S across a drug development program.
Read MoreHaving supported hundreds of modeling and simulation projects to achieve IND, NDA, BLA, sNDA, MAA and other regulatory approvals, Certara has amassed a portfolio of ‘best practices.’ This webinar, delivered by Certara’s CEO, outlines seven of these approaches, including how to couple data and knowledge, not mere data, to resolve the exploration-confirmation tension. Most important, […]
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