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
The PK scientist’s data pipeline handles a range of raw data types, including SAS, R, and other formats from multiple partners. This is particularly critical in complex trials with substantial data volumes. Effective data compliance management is vital, involving tailored compliance for exploratory studies and full compliance for clinical studies adhering to FDA’s Title 21 … 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
The cloud version of Phoenix, Phoenix Hosted, provides your PK scientists with a secured and validated Certara AWS workspace allowing for much quicker transit time from compliant data sources. It enhances productivity and supports compliance requirements by managing complex time-based data, the foundation for all PK/PD modeling. 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
临床药理信息占药品说明书的 50% 以上。不完善的临床药理开发计划会导致申办方在审评期间遇到重大问题，或影响其上市申请的批准。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
SEND datasets have become an integral part of the review, analysis, and interpretation of nonclinical toxicology studies as per FDA guidance and the needs and trend will only continue to grow. The SEND dataset creation process is challenging and often requires a combination of data integration and manual effort. 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
