Introducing P21 Community 3.0 Blog Post

May 7, 2019 We are thrilled to announce that P21 Community 3.0 is available for immediate download. This is our most ambitious release to date. We added support for new standards...

Managing Immunogenicity Using Quantitative Systems Pharmacology Blog Post

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…

FDA’s New ANDA Submissions Guidance: Key Points Blog Post

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is…