Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator Blog Post
Simcyp was used by pharma and biotech companies to inform, reduce and/or replace clinical studies for 40 Kinase Inhibitor (KI) drugs.
Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies Blog Post
Cancer treatment has evolved from generally cytotoxic therapies towards drugs that target specific pathways and alterations in cancer cells. Patients tolerate targeted therapies better, and their treatment continues over a…
FDA Trends for Accelerated Drug Approvals in Oncology Indications Blog Post
The FDA has modified and increased expectations around data needed to support accelerated approvals in oncology Unlike prior trends, randomized controlled trials will be the preferred approach to support an…
Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset Blog Post
Software will aid optimizing pre-clinical data management in accordance with global standards and guidelines. Seoul, SOUTH KOREA August 4rd – Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today…
AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists? Blog Post
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…
Understanding the Impact of FDA Modernization Act 2.0 on Drug Development Blog Post
Learn how the FDA Modernization Act 2.0 will change the drug development landscape by allowing alternative methods to animal testing.
FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers Blog Post
2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus. Reprinted with permission from Applied Clinical Trials. Applied Clinical Trials is a copyrighted publication…
What you should know about FDA Project Optimus for your oncology drug approval Blog Post
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…
FDA Modernization Act 2.0 – What does it mean for drug developers? Blog Post
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…
FDA awards new grants to support developing & assessing complex generic drugs Blog Post
Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator is being used to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) of complex generic drugs PRINCETON, N.J.— February 7, 2023. Certara…
