Tag: 儿科
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies
将 PBPK 模型应用于儿科药物开发的最佳实践框架
Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimise and replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidances on paediatrics. Best practice standards were … Continued
Empowered Patient Podcast: Using Biosimulation to Develop Pediatric Therapeutics with Lynne Georgopoulos Certara
Lynne Georgopoulos, VP Regulatory Strategy, Certara describes the company’s platform to optimize pediatric drug development using biosimulation. With an eye on pediatric diseases, Certara is employing modeling and simulation to determine how a drug developed for adults may be metabolized in children, including neonates. They are also operationalizing clinical trials to be more efficient and … Continued
Becker’s Healthcare — 儿科领导力播客 — Certara 公司监管战略副总裁,NP Lynne Georgopoulos — 应对儿科药物开发中的挑战
Lynne Georgopoulos, NP, Vice President of Regulatory Strategy at Certara, joins the podcast to share with us her insights on pediatric drug development. She touches on the history of pediatric drug regulations, current challenges, upcoming projects and more!
Quantitative Considerations for Pediatric Oncology Drug Discovery & Development
Due to the rapid and continuous physiological changes during growth and development, pediatric patients cannot be treated as “small adults.”These physiological and molecular differences include body composition (height and weight), organ function and size, receptor response (pathway, safety), and maturation of absorption, distribution, metabolism, and excretion (ADME) changes. In addition to ontogeny considerations, pediatric … Continued
Galderma 的 AKLIEF®(曲法罗汀)获得了 FDA 批准
RACE for Children Act Opens New Avenues for Pediatric Oncology Drug Development
With the long-anticipated ignition of the Research to Accelerate Cures and Equity (RACE) for Children Act on Tuesday (August 18) this week, stakeholders in the development of oncology drugs—ranging from patients and their families to clinical research sponsors and practitioners—have new hopes for advancements in more effective therapies for pediatric cancers. According to Lynne Georgopoulos, … Continued
青少年毒性研究考虑因素 — 不仅仅是 "小型 "一般毒性研究!
Outlining a pediatric clinical and safety assessment plan for investigational drugs is a required part of drug development due to regulatory legislation. These plans may include juvenile toxicity studies in animals to ensure safe and effective medicines for children. Juvenile toxicity studies are warranted when safety concerns can’t be adequately, ethically, or safely assessed in … Continued
Certara Announces Launch of Pediatrics Practice with Scientific and Regulatory Experts
Combination of experts and software helps accelerate pediatric drug development and increase clinical trial success rates PRINCETON, NJ – 2020 年 7 月 29 日 – Today, Certara®, the global leader in biosimulation, launches Certara Pediatrics, a new practice area to help biopharmaceutical companies apply model-informed drug development to their pediatric programs and better navigate the changing regulatory landscape. … Continued