As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical,...
The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other...
The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm on real-world evidence (RWE) and its adoption in the drug development process. While the collection of real-world data (RWD) and use of RWE is not...
This blog reviews trends for using health economics and outcomes research and real-world evidence to evaluate the value of medicines and health technologies.
We analyze the drug-price watchdog, ICER's (Institute for Clinical and Economic Review) "Report on Unsupported Price Increases."
Model-based Meta-analysis is a framework to compare drugs used to treat diabetic peripheral neuropathy, post-herpetic neuralgia & fibromyalgia.
This blog discusses how decision analysis approaches can help drug developers to better decisions under multiple criteria and uncertainty.
Henri Merdjan explains why topical drug formulations (e.g. intranasal and/or oral) could be valuable as a therapeutic option for COVID-19 patients.
D360 Express is a ready-to-use integrated solution tailored for scientists in smaller pharmaceutical research organizations.
© 2025 Certara. All Rights Reserved. | Legal | Privacy policy
