Results For "fda"

A close examination of BCRP’s role in lactation and methods for predicting drug distribution into milk Blog Post

The article, authored by Caroline Sychterz, Hong Shen, Yueping Zhang, Michael Sinz, Amin Rostami-Hodjegan, Brian J. Schmidt, Lu Gaohua, and Aleksandra Galetin, explores the role of the breast cancer resistance…

Certara & Ichnos Glenmark Innovation Collaboration Optimizes Dosing Strategy for Potential First-In-Class Cancer Drug Blog Post

Preclinical research on the trispecific antibody, ISB 2001, published in Nature Cancer leveraged virtual trials to select a higher starting dose that would lower costs and reduce cycle times RADNOR, PA…

オンデマンド [ISoP ウェビナー] – モデルを活かした医薬品開発（MIDD）における生理学的薬物動態（PBPK）の応用 – 規制当局の現状の受け入れ状況をご存知ですか？ Blog Post

モデルを活かした医薬品開発（MIDD）は、医薬品開発プロセスおよび規制当局による審査において重要な要素です。It is frequently utilized as part of a Clinical Pharmacology strategy to inform…

Why Should You Use LOINC Codes For SDTM? Blog Post

Ed Chappell 2024年9月16日 In this blog, we take a detailed look at LOINC Codes and SDTM. We look at several LOINC code examples and examine why it’s beneficial...

4 Ways That Mechanistic Modeling Accelerates Bispecific (and Multispecific) Antibody Drug Development Blog Post

With nine FDA-approved drugs today, 100+ in clinical development and several hundred in the preclinical stage, the market for bispecific antibodies is projected to grow to >$30B by 2028. The…

Early Development Page

当社の初期段階の臨床開発ソリューションは、候補者選定からフェーズ1までのすべての段階で専門的なサポートを提供します。

サターラ、アジア太平洋地域の医薬品開発リーダー向けにCERTAINTYフォーラム開催 Blog Post

中国、韓国、日本にて開催されるサターラ主催フォーラムを通して、モデルを活かした医薬品開発(MIDD)アプローチを活用し新薬をより早く患者に届けることを目指す研究者の交流と情報交換を促進RADNOR, PA –…

Application of physiologically based pharmacokinetic modeling of novel drugs approved by the U.S. food and drug administration Blog Post

The article from the European Journal of Pharmaceutical Sciences reviews the role of Physiologically Based Pharmacokinetic (PBPK) modeling in the FDA’s approval of novel drugs from 2019 to 2023. It…

The 25th Annual Simcyp Consortium Meeting Blog Post

Every year, the Consortium—comprising over 30 leading biopharmaceutical companies—convenes to discuss Physiologically Based Pharmacokinetic (PBPK) initiatives in drug development and their regulatory impacts. Consortium members collaborate closely with Simcyp scientists,…

Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials Blog Post

Asciminib (Scemblix®) is a novel drug with a unique mechanism of action for treating CML. It specifically targets the BCR-ABL tyrosine kinase, offering a targeted approach to the disease. {{N:1}}...