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,...
Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at...
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.
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