Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease Blog Post
RedHill Biopharma Ltd., a specialty biopharmaceutical company, developed RHB-204, a treatment for MAC, and needed help streamlining the process of getting into Phase 3 clinical trials. RHB-204 combines three well-known...
SEND Dataset Quality Control: Best Practices & Recommendations Blog Post
In this blog, Senior Product Management Director Peggy Zorn explores best practices & recommendations for SEND dataset review & visualizations.
Antibody-drug Conjugates in the Clinic: Key Considerations & the Role of Modeling in Expediting Development Blog Post
Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a cytotoxic anti-cancer drug directly to the tumor with reduced off-target damage. ADCs combine the targeting…
Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints Blog Post
データを再利用し高度な分析を組み込むことで、サロゲートエンドポイントを検証することができます。サロゲートエンドポイントは代替エンドポイントとも呼ばれ、臨床試験において臨床的に意味のあるエンドポイントの代用となるエンドポイントのことです。このデュー...Simcyp Informed Drugs Page
Simcyp™-informed Drugs 120+ novel drugs approved by regulators using the Simcyp Simulator in lieu of clinical studies Learn more about Simcyp Contact us Unlock Innovation with Simcyp Imagine bringing over...
RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes Blog Post
うっかりミス、誰にでも起こり得ます。多くの方が経験している、あるいは目にしたことのある「間違い」。時に、議論しにくいテーマでもあります。This webinar will examine common administrative and technical mistakes, errors, and omissions…
Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types Blog Post
Simcyp Simulator has been utilized to inform more than 300 label claims for 90+ novel drugs in lieu of conducting clinical studies PRINCETON, N.J.— 2023年3月7日 – Certara, Inc….
Drug Development Considerations for Live Biotherapeutic Products Blog Post
A new class of complex biologics has emerged in recent years. These are classified in a broad category of live biotherapeutic products, and regulatory guidances have been written across the…
