Category: 온디맨드 웨비나

Traditionally, PK Scientists have operated with locally installed applications to resume their PK analysis. In this environment the computer system was under control of the local IT department who would provide all necessary documentation expected by regulatory authorities to provide evidence that their computer system is CFR part 11 compliant. In the new world of … Continued

As the drug development industry strives to accelerate submission timelines and improve patient access to healthcare solutions, regulatory professionals are increasingly pressured to leverage technology to go faster. During this webinar, Heather Graham, vice president of regulatory science and medical affairs at Certara, will facilitate a panel comprising industry experts to discuss the current technology … Continued

Phoenix 클라우드 버전인 Phoenix Hosted는 PK 과학자들에게 안전하고 검증된 Certara AWS 작업 환경을 제공하여 규정 준수 데이터 소스로 부터의 전송 시간을 훨씬 단축합니다. PK/PD 모델링의 기초가 되는 복잡한 시간 기반 데이터를 관리하여 생산성을 향상시키고 규정 준수에 대한 요구사항을 지원합니다. It contributes to reduce the total cost of … Continued

The development of new drugs for rare diseases is a challenging process due to small patient populations and the high cost of clinical trials. One key challenge is identifying optimal dosing regimens. Pharmacokinetics of drugs can vary widely between individuals, and it can be difficult to obtain enough data from clinical trials to make informed decisions about dosing. … Continued

Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications. Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of … Continued

In a sector where both competition and stakeholder expectations are high, a comprehensive approach that blends digital stakeholder engagement with effective value communication is crucial for success. This presentation offers a 360-degree view on leveraging digital technologies to revolutionize how pharma companies interact with key stakeholders such as payers, providers, and patients. Simultaneously, the session … Continued

Comparing your drug and the competition in terms of efficacy and safety data in the targeted therapeutic area is critically essential for optimizing development strategies and maximizing the value of a new drug. Model-based meta-analysis (MBMA) with clinical outcome database of publications and external information has been utilized to optimize trial design in recent years. … Continued

FDA 지침에 따라 SEND 데이터셋은 비임상 독성학 연구의 검토와 분석 및 해석에 필수적인 요소이며, 이러한 요구 조건은 앞으로 강화될 것으로 보입니다. 그러나 SEND 데이터셋 프로세스는 작업자가 복잡하고 잦은 데이터 통합 작업 및 반복적인 업무를 진행해야 합니다. 이러한 과정에서 잘못된 데이터 가공, 규제요건 불일치 등의 문제는 FDA 제출과정에 큰 어려움 및 위험을 발생시킬 수 있습니다. The quality control process is critically … Continued

Discover Simcyp Biopharmaceutics, our latest addition to the Simcyp suite of technologies. This software empowers drug formulation scientists with advanced model-informed formulation development (MIFD) technology. As a proud member of the Simcyp family, Simcyp Biopharmaceutics provides a robust workbench for formulation development and optimization, maintaining the Simcyp gold standard for unparalleled formulation success. Join us … Continued