Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance Blog Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance With the release of the draft ICH M15 guidance, MIDD is no longer optional -…CertaraJune 11, 2025
Essentials of Model-informed Drug Development in Oncology Blog Essentials of Model-informed Drug Development in Oncology Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…CertaraMay 2, 2025
Streamlining Population PK Modeling with Phoenix NLME & Pirana: Bridging Efficiency and Precision in Pharmacometrics [APAC Webinar] On-Demand Webinar Streamlining Population PK Modeling with Phoenix NLME & Pirana: Bridging Efficiency and Precision in Pharmacometrics [APAC Webinar] Senior Director, Pharmacometric Software, Certara Keith has more than 20 years of global drug development…CertaraApril 24, 2025
Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study Publication Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…CertaraMarch 20, 2025
The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement Publication The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement This article explores the overlooked yet critical role of early strategic planning for payer reimbursement…CertaraFebruary 25, 2025
Certara’s Phoenix Platform – The world’s most trusted platform for PK/PD analysis and modeling Video Certara’s Phoenix Platform – The world’s most trusted platform for PK/PD analysis and modeling Today's drug candidates are more complex than ever. But with development decisions on the line,…CertaraFebruary 12, 2025
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies Publication Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2…CertaraFebruary 6, 2025
Understanding Variability in CAR-T Cell Therapy Kinetics Publication Understanding Variability in CAR-T Cell Therapy Kinetics Axicabtagene ciloleucel (axi-cel), a CAR-T cell therapy for relapsed and refractory non-Hodgkin’s lymphoma (NHL), demonstrates…CertaraJanuary 23, 2025
INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease Publication INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease The Phase 1 INTERCEPT-AD study evaluated sabirnetug (ACU193), a monoclonal antibody targeting amyloid-beta oligomers (AβOs),…CertaraJanuary 8, 2025
Advancing pharmacometrics in Africa – Transition from capacity development toward job creation Publication Advancing pharmacometrics in Africa – Transition from capacity development toward job creation This CPT article showcases, the Applied Pharmacometrics Training (APT) program, launched in 2021 by Pharmacometrics…CertaraDecember 9, 2024