Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

• Main Authors: Colleen Kuemmel (Author), Yuching Yang (Author), Xinyuan Zhang (Author), Jeffry Florian (Author), Hao Zhu (Author), Million Tegenge (Author), Shiew‐Mei Huang (Author), Yaning Wang (Author), Tina Morrison (Author), Issam Zineh (Author)
• Format: Book
• Published: Wiley, 2020-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The use of computational models in drug development has grown during the past decade. These model‐informed drug development (MIDD) approaches can inform a variety of drug development and regulatory decisions. When used for regulatory decision making, it is important to establish that the model is cr...