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
ICH M15 Guideline: What the Finalized Guideline Means for Model-Informed Drug Development Blog ICH M15 Guideline: What the Finalized Guideline Means for Model-Informed Drug Development With the release of the draft ICH M15 guidance, MIDD is no longer optional -…CertaraFebruary 18, 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
Recent applications of pharmacometrics and systems pharmacology approaches to improve and optimize drug therapy for pregnant and lactating women Publication Recent applications of pharmacometrics and systems pharmacology approaches to improve and optimize drug therapy for pregnant and lactating women The article "Recent Applications of Pharmacometrics and Systems Pharmacology Approaches to Improve and Optimize Drug…CertaraNovember 18, 2024
Enhancing Pharmacokinetics Workflows at Charles River Case Study Enhancing Pharmacokinetics Workflows at Charles River PreclinicalPhoenix™ Integral Data Repository Charles River, a global leader in drug development, sought to improve…CertaraNovember 13, 2024