Webinar: Clinical Pharmacology Investigations and Development Plan for a Therapeutic Proteins

Clinical Pharmacology Investigations and Development Plan for a Therapeutic Proteins

Link to the webinar:

https://meet.goto.com/735363149
Acces code: 735-363-149
France: +33 170 950 594

Link to download the application:
https://meet.goto.com/install

Abstract:
Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and safe therapeutic solutions for patients. Due to their molecular and biological specificities, their clinical and pharmaceutical development present some particularities and challenges in comparison to the development of new molecular entities.

Thanks to three decades of experience in the development and approval of monoclonal antibodies, it is now possible to leverage prior knowledge and to establish a typical standard plan to address the common regulatory and scientific questions.

This webinar will provide an overview of the monoclonal antibodies’ properties and their clinical pharmacology development program, including the investigation of pharmacokinetics (PK), immunogenicity, and organ impairment. Examples of specific clinical pharmacology studies investigating the drug-drug interaction (DDI) potential or manufacturing changes will be presented and discussed. This webinar will also present and discuss a potential Clinical Pharmacology development plan for monoclonal antibodies.