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…

[ISoP 网络研讨会点播] — 基于生理的药代动力学（PBPK）在模型引导的药物开发（MIDD）中的应用 — 您了解当前监管机构的接受现状吗？ Blog Post

模型引导的药物开发（MIDD）是药物开发流程与监管审评的关键组成部分，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

我们的早期临床开发解决方案可在从候选化合物选择到第一阶段的每个阶段提供专家支持。

CERTARA 引领亚太药物创新浪潮，CERTAINTY 盛会精英汇聚 Blog Post

Certara 在中国、韩国和日本举办一系列客户论坛，这些论坛旨在促进药物开发者之间的紧密合作与广泛交流，共同采用模型引导的药物开发策略，以加速新药从研发到市场的进程，让创新疗法能够更快地惠及全球患者。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}}...