Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate Publication Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate As model‐informed drug development becomes an integral part of modern approaches to the discovery of…Jim Gallagher2021 年 5 月 13 日
A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development On-Demand Webinar 将 PBPK 模型应用于儿科药物开发的最佳实践框架 Pediatric PBPK models have broad application in the drug development process and are being used…Jim Gallagher2021 年 4 月 20 日
Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development White Paper 克服研究障碍:复杂类似药开发的专家指导 Do expensive bioequivalence studies stall your generic drug approval? Learn how you can streamline complex…Certara2021 年 4 月 15 日
Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure On-Demand Webinar Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and…Jim Gallagher2021 年 4 月 1 日
Simcyp Simulator Impacts 80+ Novel Drugs Blog Simcyp Simulator 影响了超过 80 种新药的开发 250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and…Ellen Leinfuss2021 年 3 月 17 日
Physiologically- based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1% Publication Physiologically- based pharmacokinetic modeling to support bioequivalence and approval of generic products: 双氯芬酸钠局部用凝胶案例,1% Jim Gallagher2021 年 3 月 16 日
IQ WG Evaluation of PBPK Models for Organ-Impaired Populations On-Demand Webinar IQ WG Evaluation of PBPK Models for Organ-Impaired Populations • The predictive performance of physiologically based pharmacokinetic(s) (PBPK) models for PK in renal impairment…Jim Gallagher2021 年 3 月 10 日
Advancing Pediatric Drug Development Using Simcyp PBPK White Paper 应用 Simcyp™ PBPK 技术推进儿科药物研发 Jim Gallagher2021 年 3 月 4 日
Simcyp™ PBPK Simulator Brochure Simcyp™ PBPK Simulator Streamlines drug development by using PBPK modeling to predict drug behavior in virtual populations, optimize…Jim Gallagher2021 年 1 月 22 日
Liquid Biopsy Enables Quantification of the Abundance and Interindividual Variability of Hepatic Enzymes and Transporters Publication Liquid Biopsy Enables Quantification of the Abundance and Interindividual Variability of Hepatic Enzymes and Transporters Certara2020 年 11 月 13 日