Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program Blog Simcyp PBPK Simulatorをお客様の医薬品開発プログラムに統合する10のメリット Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…Certara2021年6月22日
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 A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development 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 Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development 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 Impacts 80+ Novel Drugs 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: A case for diclofenac sodium topical gel, 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 Simcyp PBPK を用いた小児用医薬品開発の促進 Jim Gallagher2021年3月4日