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Simcyp™ Success Stories

Simcyp has led the way in the development and application of physiologically-based pharmacokinetics (PBPK) in drug development. From addressing safety issues such as drug-drug-interaction (DDI), to extrapolation of clinical outcomes in untested populations such as pediatric and organ impaired, Simcyp has delivered on its promise of expediting drug development for >25 years. Simcyp PBPK models describe the drug concentration in different organs, behavior across different body tissues, and thus help to inform clinical trial design, first-in-human dosing, formulation design, dose differentiation for special populations, and predictions related to potential DDIs

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Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease
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Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan DiseaseCase Study

Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease

Congenital adrenal hyperplasia (CAH) affects about 400,000 patients worldwide. Current therapy for CAH uses a variety of generic glucocorticoid steroids (including hydrocortisone, dexamethasone, prednisolone,…

All Simcyp case studies

Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials

Certara Products - Simcyp, Modeling and Simulation - PBPK, Case Study

Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy

Certara Products - Simcyp, Modeling and Simulation - PBPK, Case Study

Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease

Case Study - Simcyp Success LP - featured, Certara Products - Simcyp, Formulation, Modeling and Simulation, Modeling and Simulation - PBPK, Pediatrics, Rare and Neglected Diseases, Therapeutic Specialties, Case Study

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA

Case Study - Simcyp Success LP - Latest, Certara Products, Certara Products - Simcyp, Drug-Drug Interactions (DDI), Modeling and Simulation - PBPK, Pediatrics, Rare and Neglected Diseases, Therapeutic Specialties, Case Study

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

Certara Products, Certara Products - Simcyp, Drug-Drug Interactions (DDI), Modeling and Simulation - PBPK, Oncology/Hematology, Therapeutic Specialties, Case Study

Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children

Central Nervous System (CNS), Certara Products, Certara Products - Simcyp, Drug-Drug Interactions (DDI), Modeling and Simulation - PBPK, Pediatrics, Therapeutic Specialties, Case Study

Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates

Central Nervous System (CNS), Certara Products - Simcyp, Modeling and Simulation - PBPK, Pediatrics, Rare and Neglected Diseases, Therapeutic Specialties, Case Study

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder

Central Nervous System (CNS), Certara Products - Simcyp, Formulation, Modeling and Simulation, Modeling and Simulation - PBPK, Pediatrics, Therapeutic Specialties, Case Study

Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates

Central Nervous System (CNS), Certara Products - Simcyp, Modeling and Simulation - PBPK, Pediatrics, Rare and Neglected Diseases, Therapeutic Specialties, Case Study

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs

Certara Products, Certara Products - Simcyp, Drug-Drug Interactions (DDI), Modeling and Simulation - PBPK, Rare and Neglected Diseases, Therapeutic Specialties, Case Study

Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy

Certara Products - Simcyp, Modeling and Simulation - PBPK, Pediatrics, pre-update, Rare and Neglected Diseases, Therapeutic Specialties, Case Study

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

Central Nervous System (CNS), Certara Products, Certara Products - Simcyp, Drug-Drug Interactions (DDI), Formulation, Modeling and Simulation, Modeling and Simulation - PBPK, Therapeutic Specialties, Case Study