Tag: 小児
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies
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 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 -Pediatric Leadership Podcast - 小児用医薬品開発における課題への取り組み
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
ガルデルマ社、AKLIEF®（トリファロテン）のFDA承認を取得
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
Juvenile toxicity studies considerations – not just “mini” general tox!
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
