What does the Clin Pharm Plan for a Biologic Look Like? скачать в хорошем качестве

What does the Clin Pharm Plan for a Biologic Look Like?

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 provided an overview of monoclonal antibodies’ properties and their clinical development program, including the investigation of pharmacokinetics (PK), immunogenicity, and the potential impact of organ impairment. Examples of specific clinical pharmacology studies investigating the drug-drug interaction (DDI) potential or manufacturing changes were presented and discussed. This webinar also presented a potential clinical pharmacology development plan for monoclonal antibodies. Please visit us at https://www.certara.com/services/clin... to learn more.