Results For "fda"

Certara Acquires Formedix LLC to Increase Data Standardization Across Clinical Trials for Faster Study Setup, Time to Analysis and Submissions Blog Post

Formedix ryze cloud based clinical metadata repository and SDTM automation suite and Certara Pinnacle 21 data validation platform combine to power faster clinical trials Princeton, NJ – October 10th, 2023…

Do the Scale-up & Post approval Changes (SUPAC) Guidance Documents Still Apply to Drug Developers? Blog Post

Do you remember the 1990s? The Soviet Union fell, Friends was the most popular TV show, and for some inexplicable reason, hammer pants were a viable fashion option. But while…

Clinical Pharmacology Issues That Can Lead to Approvability Problems for Your Drug Blog Post

今日、臨床薬理情報は医薬品添付文書の50％以上を占めています。Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the…

Using customer engagement technology to create value communication tools for ABILIFY MAINTENA® (aripiprazole) Blog Post

Otsuka identified several weaknesses in their existing workflow for developing value communication tools. In particular, the time-consuming process of updating or modifying tools using custom app vendors would cause significant...

Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software Blog Post

Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software PRINCETON, N.J.— 2023年9月19日 – Certara, Inc., a global leader in biosimulation software, today announced the release of Phoenix…

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software Blog Post

Dedicated team of global regulatory experts delivers submissions in increasingly shorter timelines. PRINCETON, NJ – September 19th,  2023 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in biosimulation, today announced it…

Clinical Pharmacology Regulatory Strategy Page

複雑な規制環境を乗り越え、最適な医薬品開発の道筋を実現するために、臨床薬理における薬事戦略でサターラと連携しましょう。

Methods to Increase Signal Finding in Rare Disease Drug Development Blog Post

希少疾患の治療薬に関する規制状況は大きく変化しています。Gleaning from several recent health authority advisory committee deliberations have provided a glimpse into the science and complexity…

Simcyp Publications and Independent Applications Page

Simcyp™ Publications and Independent Applications Driving drug development innovation with Simcyp Simcyp publication statistics We are proud to share our publications by the Simcyp R&D Team (1997 – Present) and...

Secondary Intelligence™: Empowering Decision-Making in Drug Development & Safety Assessment Blog Post

医薬品の有害事象は、患者へのリスクとなるだけでなく、開発や治療目的の実現を阻害する要因にもなり得ます。Such effects can arise from primary pharmacology…