Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children Case Study Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…CertaraAugust 26, 2021
Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Case Study Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…CertaraAugust 26, 2021
Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Case Study Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…CertaraAugust 12, 2021
PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Case Study PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…CertaraAugust 12, 2021
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…CertaraJuly 29, 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
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
Galderma Achieves FDA Approval of AKLIEF® (trifarotene) Case Study Galderma Achieves FDA Approval of AKLIEF® (trifarotene) In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…CertaraNovember 9, 2020
Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions Publication Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions CertaraJune 1, 2016
Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko Blog Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions…CertaraDecember 1, 2015