Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies Blog Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies Cancer treatment has evolved from generally cytotoxic therapies towards drugs that target specific pathways and…Certara2023年11月17日
The “Animal Rule” – What if a clinical trial simply isn’t ethical? ブログ The “Animal Rule” – What if a clinical trial simply isn’t ethical? Clinical trials always pose a challenge to demonstrating a drug’s safety and efficacy. Sometimes, the…Certara2023年11月10日
Can’t ChatGPT Do That? Practical Applications for AI in Drug Discovery & Development Blog ChatGPTではできない?!創薬・医薬品開発におけるAIの実用化 Explore how Certara.AI tackles the limits of generalized GPTs like ChatGPT to transform drug discovery,…Certara2023年10月31日
How Biosimulation & AI Tech Could Solve Pharma’s R&D Productivity Crisis Blog バイオシミュレーションとAIを活用し、製薬企業が直面する研究開発生産性の課題を解決するには 医薬品開発には骨の折れるほど時間がかかり、気の遠くなるような費用がかかります。In a 2010 article, Stephen…Certara2023年10月27日
Authoring & Assembling IND and CTA Applications – Insights and Updates Blog INDおよびCTA申請書類の作成と組み立て – インサイトと最新情報 Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for…Certara2023年10月23日
Advancing Rectal Drug Delivery: A Breakthrough in Physiologically Based Pharmacokinetic Modeling Blog Advancing Rectal Drug Delivery: A Breakthrough in Physiologically Based Pharmacokinetic Modeling This blog explains how Certara’s Simcyp team developed and tested a model in the Simcyp…Certara2023年10月20日
10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions Blog eCTD 4.0について知っておくべき10のこと:今後の規制当局への提出 In this blog post, we explore the top 10 things you need to know about…Certara2023年10月17日
Do the Scale-up & Post approval Changes (SUPAC) Guidance Documents Still Apply to Drug Developers? ブログ Do the Scale-up & Post approval Changes (SUPAC) Guidance Documents Still Apply to Drug Developers? Do you remember the 1990s? The Soviet Union fell, Friends was the most popular TV…Certara2023年10月6日
Developing Pediatric PBPK Models for Differing Ethnic Populations Blog 異なる民族集団を対象とした小児用PBPKモデルの開発 Physiologically-based pharmacokinetic (PBPK) modeling has proven invaluable in drug development, especially for pediatric populations, because…Certara2023年9月29日
Maximizing Reusability for Drug Submissions to Different Health Authorities Blog Maximizing Reusability for Drug Submissions to Different Health Authorities Many drug developers have products that they want to submit for marketing approval in several…Certara2023年9月21日