Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success Blog Post
抗体薬物複合体（ADC）は、腫瘍細胞を消滅させるユニークな方法であり、単独療法であれ併用療法であれ、腫瘍学において十分に利用されていない免疫治療薬の選択肢です。The first FDA approval…
Incorporating the patient voice into clinical trial summaries Page
サターラは、EMAおよび英国の規制に対応するプレーンランゲージ文書を提供しており、臨床試験のコミュニケーションに適したカスタマイズ可能なテンプレート、インフォグラフィック、アクセシブルなデザインを備えています。
Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations Blog Post
This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK)…
Complex patient profile and narrative template needs Blog Post
世界的な製薬企業が、非常に複雑な試験のひとつにおいて、患者プロファイル（PPL）およびナラティブのテンプレート作成をサターラに依頼しました。Historically, the Sponsor’s statistical programming team had...
Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program Blog Post
Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation impact on drug approval has grown significantly over the past years, with about 45% percentage…
Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers Blog Post
This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence and Value Communications Symposium. This session featured the following four speakers: Shawn W. Bates is…
Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting Blog Post
Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on 2021年4月15日 was not any different. The agenda…
