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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 platformPublication

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 MalignanciesPublication

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 KineticsPublication

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 analysesPublication

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 HospitalsPublication

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 regionPublication

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).

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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
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