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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 alterations in cancer cells. Patients tolerate targeted therapies better, and their treatment continues over a period of years, instead of a few weeks. These improvements in cancer treatment spurred the FDA’s Project Optimus initiative which has altered the criteria used … Continued

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 challenges are beyond difficult, presenting situations where it isn’t ethical or feasible to demonstrate efficacy in humans.  Consider the following scenarios (which have occurred):    A bioterror attack with people exposed to a dangerous disease (anthrax, plague, Ebola) A natural hazard … Continued

Can’t ChatGPT Do That? Practical Applications for AI in Drug Discovery & Development

Deep learning/artificial intelligence concepts have been around for decades, with significant advancements made in the late ‘80s and throughout the ‘90s as scientists experimented with recurring neural networks (RNNs). As our concept and expectations of deep learning evolved over the years, data quality and the computing power needed to train and deploy new models often … Continued

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。スティーブン・ポールが2010年に発表した論文にて、新薬の開発には18憶ドル(1.8billion USD)かかり、発見から承認までに平均13年かかると推定しています。These excesses occurred because drug development is a fundamentally complex and risky process that is also subject to rigorous … Continued

Authoring & Assembling IND and CTA Applications – Insights and Updates

Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for the initiation of clinical drug trials, and these applications have commonalities and differences throughout the world. If you’re initiating clinical trials in multiple countries, then planning for these different submissions is critical to the efficiency of your drug program. Many … Continued

The SEND 2023 Updates Nonclinical Drug Developers Need to Know

The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for exchanging nonclinical data related to drug development. SEND was developed by the Clinical Data Interchange Standards Consortium (CDISC), a globally recognized, not-for-profit organization that develops data standards with the input of pharmaceutical industry experts. The FDA requires drug developers to use … Continued

二重特異性(および多特異性)抗体(bsAbs)医薬品開発を加速する4つのメカニズム・モデリングの方法

With nine FDA-approved drugs today, 100+ in clinical development and several hundred in the preclinical stage, the market for bsAbs is projected to grow to >$30B by 2028. The distinct advantages of bsAbs, such as improved selectivity and specificity, increased efficacy, and lower toxicity, will result in measurable benefits for cancer patients. But bsAbs are … Continued

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