Sr. Prin. Scientist Certara Plc SHEFFIELD, United Kingdom
Lately, the oral peptide drugs have been focused to develop due to the successful development of Rybelsus and Mycapssa. However, their large molecular weight and stability issue in the GI tract are two major obstacles. At the same time, PBBM/PBPK are well established for oral route. However, it is nothing reported for the modeling in oral peptide delivery. In this session, from modeling set up and development, what is the criteria, what is missing? Today, successful modeling and prediction are not available. why? In this presentation, why no reliable modeling is available in this space will be presented (what would be the key parameters. If we know, how can we obtain such parameters for modeling/prediction) as well as either clinical PK outcome or regulatory prospective will be presented. this program idea is supported by OBAM community.
Learning Objectives:
Participants will gain the idea of modeling something new and key parameters obtaining by different experimental methodologies and technologies for the modality specific evaluation
Participants will be able to build the knowledge what would be the current problems and what need to be done/solve the problems.
Participants will develop a network in discovery, analytical, formulation, preclinical, and clinical areas and regulatory agents as well as modeling experts.
Participants will develop an understanding of the similarities and differences between small- and large-molecule drugs, how these affect their respective ADME properties and the insight afforded by mechanistic PBPK modelling.
