Skip to main content
search

Publications

Sign up

Featured publication

Latest publications

Popular publications

Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform
Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform

Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform

Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies

Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies

Understanding Variability in CAR-T Cell Therapy Kinetics
Understanding Variability in CAR-T Cell Therapy Kinetics

Understanding Variability in CAR-T Cell Therapy Kinetics

Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses
Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses

Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: A Retrospective Comparative Effectiveness Study of Mortality in US Hospitals
Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: A Retrospective Comparative Effectiveness Study of Mortality in US Hospitals

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: A Retrospective Comparative Effectiveness Study of Mortality in US Hospitals

Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region
Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region

Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region

Collection
Simcyp Publications and Independent Applications

We are proud to share our publications by the Simcyp R&D Team (1997 – Present) and independent applications of Simcyp by industry, academia, and regulatory organizations (2007 – Present).

Learn more

All publications

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

ADC, Certara Services, Clinical Pharmacology, Clinical Trials, Drug Development, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PK/PD, Oncology/Hematology, Pharmacometrics, PopPK Modeling and Simulation, Regulatory, Therapeutic Specialties, Publication

MIDD in Japan – Implementations, challenges and opportunities

Drug Development, Modeling and Simulation, Publication

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

Biologics, Certara Products, Certara Services, Clinical Pharmacology, Clinical Trials, Drug Development, Drug Safety, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PK/PD, Oncology/Hematology, Publication

Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores

Modeling and Simulation - QSP, Publication

Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform

Modeling and Simulation - QSP, 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

Certara Services, Clinical Trials, Drug Development, Model Informed Drug Development, Modeling and Simulation, Oncology/Hematology, Pharmacometrics, PopPK Modeling and Simulation, Therapeutic Specialties, Publication

Understanding Variability in CAR-T Cell Therapy Kinetics

Clinical Trials, Drug Development, Model Informed Drug Development, Modeling and Simulation, Oncology/Hematology, Pharmacometrics, Publication

Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses

Clinical Trials, Drug Development, Drug Safety, Modeling and Simulation - PK/PD, Publication

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: A Retrospective Comparative Effectiveness Study of Mortality in US Hospitals

Publication

Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region

Model Informed Drug Development, Modeling and Simulation - PBPK, Modeling and Simulation - PK/PD, Modeling and Simulation - QSP, Publication

INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease

Certara Products, Certara Services, Clinical Pharmacology, Clinical Trials, CODEX, Drug Development, Model-Based Meta-Analysis (MBMA), Modeling and Simulation - PK/PD, Pharmacometrics, PK/PD, Real World Data, Publication

Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards

Certara Products - Simcyp, Drug-Drug Interactions (DDI), Modeling and Simulation - PBPK, Publication
Be the first to get the latest

Transforming drug development is not just our goal—it’s our obsession. If it’s yours too, then be the first to know of new insights and join us in pushing the boundaries of science.