Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]
Read MoreIn this webinar, we will discussed how we combined clinical and pre-clinical approaches to develop a PBPK model to predict the exposure of darunavir, a protease inhibitor commonly used to treat pregnant HIV+ patients. Moreover, we elaborated on the study design, data collection, and analyses that were used to investigate the clinical pharmacokinetics of antiretroviral agents during pregnancy.
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With the swearing in of Dr. Scott Gottlieb as Commissioner of Food and Drugs in May, many have wondered as to the climate he will set for the US FDA. Certara’s mission and business thesis aligns with the FDA’s July 7 announcement regarding the steps it is taking to implement the 21st Century Cures Act. […]
Read MoreCertara’s due diligence/asset evaluation teams are comprised of drug development and commercialization experts who advise on acquiring or investing in emerging biopharma companies.
Read MoreAchieving a pathway-based approach to more efficient chemical risk assessment.
Read MoreIn this webinar, Dr. Tom Snowden demonstrated: why reduction methods are a potent and necessary tool in the modeler’s arsenal; how reduction methods can be applied to QSP models; and, how model reduction can be used to extract scientific and business insights from complex models.
Read MorePRINCETON, NJ – July 13, 2017 – Certara today announced that Professor Jennifer B. Dressman, PhD, has been appointed to the Simcyp Scientific Advisory Board (SAB) to further strengthen its status in the biopharmaceutics field.
Read MoreWatch this webinar with C-Path’s Dr. Klaus Romero to learn how they integrated these components into the latest version of the Simcyp Simulator to establish a robust resource that will help development teams and regulators evaluate the safety and efficacy of novel anti-TB drug regimens.
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Upon the completion of the Human Genome Project, the lead investigator, Dr. Francis Collins remarked: Science is a voyage of exploration into the unknown. We are here today to celebrate a milestone along a truly unprecedented voyage, this one into ourselves. Alexander Pope wrote, “Know then thyself. Presume not God to scan. The proper study […]
Read MorePRINCETON, NJ – June 6, 2017 – Certara today launched its Clinical Outcomes Database Explorer (CODEx). An intuitive, web-based platform, CODEx enables drug development teams to easily visualize, explore, analyze and communicate content from Certara’s Clinical Trial Outcomes Databases and assess a given compound’s probability of success against competitor drugs.
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