PBPK modeling approaches to assess risks associated with bioequivalence in drug development On-Demand Webinar PBPK modeling approaches to assess risks associated with bioequivalence in drug development In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting…Jim Gallagher2021 年 5 月 19 日
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…Certara2021 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