Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Case Study Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…CertaraAugust 26, 2021
Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Case Study Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…CertaraAugust 12, 2021
PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Case Study PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…CertaraAugust 12, 2021
Succeeding in Value Communication: Introduction Blog Succeeding in Value Communication: Introduction Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding…CertaraAugust 5, 2021
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…CertaraJuly 29, 2021
What is BaseCase? Video What is BaseCase? Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams…CertaraJuly 20, 2021
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies Case Study Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…CertaraJuly 14, 2021
Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers Blog Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence…CertaraJune 18, 2021
Three Pathways have emerged in Innovative Access Agreements On-Demand Webinar Three Pathways have emerged in Innovative Access Agreements The days of simply determining the market demand for a new drug as a function…CertaraJune 11, 2021
Outcomes Based Agreements On-Demand Webinar Outcomes Based Agreements The days of simply determining the market demand for a new drug as a function…CertaraJune 11, 2021