Galderma Achieves FDA Approval of AKLIEF® (trifarotene) Case Study Galderma Achieves FDA Approval of AKLIEF® (trifarotene) In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…CertaraNovember 9, 2020
Danazol oral absorption modelling in the fasted dog: An example of mechanistic understanding of formulation effects on drug pharmacokinetics Publication Danazol oral absorption modelling in the fasted dog: An example of mechanistic understanding of formulation effects on drug pharmacokinetics CertaraOctober 30, 2020
PBPK modeling supports approval of breakthrough cancer drug Video PBPK modeling supports approval of breakthrough cancer drug Pharmacyclics’ (now AbbVie) Imbruvica (ibrutinib) is an anticancer drug targeting B-cell malignancies. Leveraging the US…CertaraOctober 23, 2020
Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy Publication Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy Model-informed precision dosing (MIPD) has become synonymous with modern approaches for individualizing drug therapy, in…CertaraOctober 12, 2020
Intro to Smart In Silico Tools to Aid in Translating In Vitro & In Vivo Studies On-Demand Webinar Intro to Smart In Silico Tools to Aid in Translating In Vitro & In Vivo Studies Safety issues account for about a quarter of the attrition in drug projects, and can…CertaraOctober 5, 2020
Secondary Intelligence Fact Sheet Secondary Intelligence Predicts off-target risks, streamlining secondary pharmacology analysis for safer drug development.CertaraSeptember 4, 2020
VIVD: Virtual in vitro distribution model for the mechanistic prediction of intracellular concentrations of chemicals in in vitro toxicity assays Publication VIVD: Virtual in vitro distribution model for the mechanistic prediction of intracellular concentrations of chemicals in in vitro toxicity assays CertaraJune 28, 2020