Tag: Simcyp
Certara Releases Simcyp™ PBPK Simulator Version 20, Including Newly Expanded Biologics Software
Unique capabilities expand the types of drugs, modalities, populations, and development questions modeled using the Simcyp PBPK Simulator PRINCETON, NJ.— 2021 年 1 月 27 日– Certara, Inc., the global leader in biosimulation, today announced the release of version 20 of its Simcyp™ Physiologically-based Pharmacokinetic (PBPK) Simulator platform. Simcyp PBPK Simulator version 20 provides new models for … Continued
Development and Application of a Physiologically-Based Pharmacokinetic Model to Predict the Pharmacokinetics of Therapeutic Proteins from Full-term Neonates to Adolescents
Authors: Xian Pan, Felix Stader, Khaled Abduljalil, Katherine L. Gill, Trevor N. Johnson, Iain Gardner & Masoud Jamei Abstract Physiologically-based pharmacokinetic (PBPK) modelling provides an integrated framework to predict the disposition of small molecule drugs in children and is increasingly being used for dose recommendation…
Simcyp™ PBPK Simulator
利用虚拟患者加速药物和疫苗研发
Children, the elderly, pregnant women, and other different populations may need different medication and vaccine doses to optimize safety and efficacy. But using conventional clinical trials to determine dosing for different populations can be difficult for ethical and logistical reasons. Virtual patients that vary physiologically can be used to understand how new vaccines and medicines … Continued
Itraconazole – Comparison of PBPK models for evaluation of clinical PK exposure and DDIs
Since the withdrawal of Ketoconazole due to concerns over hepatotoxicity, Itraconazole is commonly used in DDI studies as a strong selective inhibitor of CYP3A4. A number of PBPK models are available for use in the Simcyp Simulator including, the First Order and ADAM library files and the recently published models by the IQ Consortium. In … Continued
Application of Physiologically-based Pharmacokinetics (PBPK) to Personalized Dosing
根据机制性模型发现和开发用于免疫肿瘤学的双特异性抗体：探戈需要 2 人配合
More than 50 bispecific antibodies are in oncology clinical development with a large diversity in formats, directed at a range of immune and tumor targets. Bispecifics have demonstrated the potential for enhanced efficacy and reduced systemic toxicity. However, they are complex modalities with challenges to overcome in early clinical trials, including selection of relevant starting … Continued
Predicting Drug Pharmacokinetics in Pregnancy, Fetal, and Lactation Using PBPK
Most drug labels do not provide dosing guidance for pregnant and lactating women, yet in the U.S. alone, more than 6 million women are pregnant each year, and it is estimated that more than 90 percent take at least one medication while pregnant or lactating. Simcyp has developed and published papers on its time varying … Continued
