Historically, the FDA has required drug discovery and development programs to include animal testing. With the 2022 passage of the FDA Modernization Act 2.0, the definition of “nonclinical tests” conducted to support pharmaceutical development has been broadened to include adjunct and complementary testing methods. In this webinar with Certara’s Dr. Jim Herman, he will discuss how scientists can use innovative, … Continued

Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored. Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. What’s more, for many … Continued

Historically, the FDA has required drug discovery and development programs to include animal testing. This requirement has ended with the 2022 passage of the FDA Modernization Act. This change has opened the door for expanded use of alternatives to animal testing including biosimulation, organ-on-a-chip, and cell based assays. In this panel discussion with Nasdaq’s David … Continued