FDA’s Lykos Rejection Delays—But Doesn’t Stop—Psychedelic Therapies
Certara's Dr. Fran Brown, Senior Vice President of Drug Development Science, is quoted in this…
Certara2024 年 8 月 26 日
Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator
The article "Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system…
Certara2024 年 8 月 26 日
Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)
The article “Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL)…
Certara2024 年 8 月 26 日
The Uncertain Path Forward for Psychedelic Medicine
Certara's Dr. Fran Brown, Senior Vice President of Drug Development Science, is quoted in this…
Certara2024 年 8 月 26 日
Streamline your clinical trials with automated metadata management
When it comes to efficient clinical study build, content is king. Most importantly: metadata content.…
Certara2024 年 8 月 26 日
Regulatory requirements for annotated CRFs made easy
aCRFs are a mandatory requirement of the FDA, and therefore a key submission deliverable for…
Certara2024 年 8 月 26 日
Resmetirom: A pioneering NASH clinical program
Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…
Certara2024 年 8 月 23 日
Overcoming CMC Challenges in Cell and Gene Therapy: Part I
In this Manufacturing Chemist article, Certara's Drs. Hien Anh Bruno and Deven Shah discuss the…
Certara2024 年 8 月 23 日
