Applying decision analysis to drug development for COVID-19 & future pandemics
This blog discusses how decision analysis approaches can help drug developers to better decisions under multiple criteria and uncertainty.
Month: April 2020
Certara Launches New Version of Simcyp® Simulator for Population-Based Pharmacokinetic Modeling and Simulation
Version 19 offers mechanistic models for assessing maternal-fetal drug risk, developing drug formulations, and optimizing dermal and transdermal drug development
규제 관련 문서 및 의료 문서 작성
High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write these documents, but also to act as a strategic partner and address key issues.
Considerations for Management of Clinical Trials and Regulatory Filing Strategy in Light of COVID-19
COVID-19 has the potential to negatively impact critical activities such as patient recruitment, patient safety and ensuring data integrity. Thus, clinical developers should review their planned regulatory filing strategies to determine if modifications are required. Attend this webinar to learn mitigation strategies and best practices that you can begin implementing now. 발표자 Demetrius Carter, SVP … Continued
Predicting Drug Exposure in Cancer Patients Using a PBPK Oncology Population
PBPK modeling using a virtual oncology population can help to predict exposure and accelerate the development of safe and efficacious oncology drugs.
Certara Launches COVID-19 Pharmacology Online Resource Center
Funded by the Bill & Melinda Gates Foundation, the online Center helps accelerate therapeutics for COVID-19 by integrating clinical pharmacology, innovation and collaboration
Phoenix NLME 및 Trial Simulator를 통한 경구 테스토스테론 대체물의 FDA 승인
Clarus Therapeutics received FDA approval for an oral testosterone (T) replacement drug. This webinar will review how Phoenix NLME, population PK/PD M&S tool, and Trial Simulator supported this approval.
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