Training Your Way Page
Explore Certara University's flexible learning including Winnonlin training & PK/PD Modeling courses. Choose self-paced, instructor-led, or custom courses.
Certification Resources & FAQ Page
Preparing for the Certification Courses Frequently Asked Questions 1. Do I need to install or have access to the software version that I am being certified on?It is recommended to practice your skills using Phoenix on the version for which...
Safety and Pharmacovigilance Page
Explore Certara's Pharmacovigilance (PV) writing services for seamless drug safety and pharmacovigilance document compliance, leveraging advanced expertise and technology.
Academic Centers of Excellence Page
As regulators and sponsors recognize the growing importance of model-informed drug development (MIDD), Certara is committed to educating the next generation of experts in this field, on a global basis. We are achieving that goal by partnering with eminent scientists...
Using PBPK Models to Assess Fetal Drug Exposure Blog Post
The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting from fetal exposure to drugs. Thalidomide was used to treat morning sickness in pregnant women. By the time it was banned in 1962, more than...
Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions Blog Post
Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and...
Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption Blog Post
The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological medications or assessing the toxicological liability of commercially-used chemicals. Historically, animal models were used to evaluate dermal drug absorption prior to clinical testing. However, both...
Using a Pharmacology to Payer Framework to Support Product Development Blog Post
Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development...
Using M&S to Evaluate Oncology Drug Dosing Blog Post
There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences...
Achieving Compliance with the FDA’s eCTD Mandate Blog Post
The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF...
