신약 개발의 확실성 증가

Faced with more and more complex clinical research than ever before, regulatory writers are facing new demands. Along with eCTD structural mastery, writers must bring to their task data integration skills, consistent approaches to explanation, and a collaborative spirit.&nbsp;&nbsp; AI-powered writing software, CoAuthor™, helps your writing team to accelerate the drafting and submission of quality &hellip; <a href="https://kr.certara.com/webinar/ai-powered-regulatory-writing-software-frequently-asked-questions-by-japanese-customers-japanese-webinar/">Continued</a>

Moxidectin for Women’s Health Equity Model-Informed Drug Development is increasingly impacting public health and regulatory decision-making in support of global health initiatives.&nbsp; In this webinar, we will share a recent global health case study on the use of&nbsp; pharmacokinetic (PK) and physiologically based pharmacokinetic (PBPK) modeling of moxidectin to understand the impact of drug exposure &hellip; <a href="https://kr.certara.com/webinar/from-research-to-real-world-impact-a-model-informed-drug-development-midd-framework-to-support-understudied-populations/">Continued</a>

Webinar times: 10am Japan &amp; Korea Feb 20th 9am China Feb 20th 8pm US ET Feb 19th Navigating early drug development is critical to ensuring the long-term success of therapeutic candidates. This webinar explores key strategies to overcome common challenges, with expert insights from APAC and US perspectives. We will begin by addressing the importance &hellip; <a href="https://kr.certara.com/webinar/unlock-global-regulatory-success-overcoming-early-drug-development-challenges-apac-webinar/">Continued</a>

A key drug development safety consideration is whether the drug candidate will interact with co-medications. Drug-drug interaction (DDI) studies are used to help assess this risk. These studies quantify the impact of the drug candidate on key drug-metabolizing enzymes. The most studied metabolic enzymes are the cytochrome P450 (CYP) enzyme family members. Recommended index substrates … Continued

Accelerate your FDA review process with a rolling NDA/BLA eCTD submission with Certara’s GlobalSubmit eCTD software and eCTD publishing specialists

Pharmaceutical market access, sales, and field teams rely on high-quality, effective content to demonstrate their products’ value globally. As companies expand internationally, effectively rolling out content that meets global and local needs becomes challenging. These materials typically include  These diverse content types are vital in supporting market access strategies, informing reimbursement discussions, and driving sales … Continued