Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates Case Study Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates Radiprodil is a selective allosteric modulator of the NR2B N-methyl-D-aspartate receptor GluN2B-NMDA that was being…Certara2021 年 8 月 26 日
Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder Case Study Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder Quetiapine is an atypical antipsychotic for treating schizophrenia, bipolar depression, bipolar mania that helps to…Certara2021 年 8 月 26 日
Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates Case Study Simcyp 年龄定义功能助力优化新生儿 Everolimus 给药方案 Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures…Certara2021 年 8 月 26 日
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…Certara2021 年 8 月 26 日
Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy Case Study Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy Certara2021 年 8 月 20 日
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…Certara2021 年 8 月 12 日
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…Certara2021 年 8 月 12 日
Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Case Study Simcyp™ Simulator 证明了生物等效性 (BE),无需进行昂贵的临床研究 In this case study, the sponsor’s closing of a manufacturing site required that one of…Certara2021 年 7 月 29 日
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study 使用 Simcyp Simulator 的 DDI 监管典范案例:Ibrutinib (Imbruvica®) Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…Certara2021 年 7 月 29 日
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking On-Demand Webinar PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking This webinar was presented on 2021 年 6 月 30 日 by David R. Taft, Ph.D. Professor, Pharmaceutics,…Certara2021 年 7 月 26 日