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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, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir and…

Latest publications

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MIDD in Japan – Implementations, challenges and opportunities

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

炎症性腸疾患の臨床スコアを予測するための戦略として、機械学習とメカニズムモデリングを組み合わせる

Popular publications

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

再発または難治性の骨髄線維症およびその他の骨髄系・固形腫瘍を対象としたNavtemadlinの集団薬物動態・薬力学解析

Understanding Variability in CAR-T Cell Therapy Kinetics

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

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: 米国の病院における死亡率を対象とした、レトロスペクティブ比較研究

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

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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

炎症性腸疾患の臨床スコアを予測するための戦略として、機械学習とメカニズムモデリングを組み合わせる

Modeling and Simulation - QSP, Publication

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

Modeling and Simulation - QSP, Publication

再発または難治性の骨髄線維症およびその他の骨髄系・固形腫瘍を対象としたNavtemadlinの集団薬物動態・薬力学解析

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: 米国の病院における死亡率を対象とした、レトロスペクティブ比較研究

論文

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：アルツハイマー病による軽度認知障害または軽度認知症の被験者を対象とした、サビルネトゥグ静脈内投与のフェーズ1試験

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

出版物

Featured 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

Latest publications

MIDD in Japan – Implementations, challenges and opportunities

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

炎症性腸疾患の臨床スコアを予測するための戦略として、機械学習とメカニズムモデリングを組み合わせる

Popular publications

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

再発または難治性の骨髄線維症およびその他の骨髄系・固形腫瘍を対象としたNavtemadlinの集団薬物動態・薬力学解析

Understanding Variability in CAR-T Cell Therapy Kinetics

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

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: 米国の病院における死亡率を対象とした、レトロスペクティブ比較研究

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

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

MIDD in Japan – Implementations, challenges and opportunities

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

炎症性腸疾患の臨床スコアを予測するための戦略として、機械学習とメカニズムモデリングを組み合わせる

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

再発または難治性の骨髄線維症およびその他の骨髄系・固形腫瘍を対象としたNavtemadlinの集団薬物動態・薬力学解析

Understanding Variability in CAR-T Cell Therapy Kinetics

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

Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: 米国の病院における死亡率を対象とした、レトロスペクティブ比較研究

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

INTERCEPT-AD：アルツハイマー病による軽度認知障害または軽度認知症の被験者を対象とした、サビルネトゥグ静脈内投与のフェーズ1試験

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

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