Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate On-Demand Webinar Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…CertaraJuly 15, 2021
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta Case Study Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…CertaraJuly 14, 2021
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies Case Study Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…CertaraJuly 14, 2021
Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program Blog Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…CertaraJune 22, 2021
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…CertaraMay 19, 2021
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…CertaraMay 13, 2021
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…CertaraApril 20, 2021
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…CertaraApril 15, 2021
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…CertaraApril 1, 2021
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…CertaraMarch 17, 2021