SEKISUI XenoTech’s scientists have spent over 25 years ensuring client data is IND-ready. Over this time, we have seen just how much preclinical study planning can vary depending on the chemical properties of the molecule, indication, the company’s size and funding, internal capabilities, and other factors.
As the pharmacokinetic/pharmacodynamic (PK/PD) profile of a molecule is elucidated with each study, the most beneficial next steps can become difficult to see with certainty. Additionally, even nonclinical studies that have been around for years and considered standard continue to evolve as science advances and emphasis on metabolites and DDI potential grows. These and other factors further complicate the task of meeting regulatory expectations… Continue Reading.