Which regulatory markets can the data support?
The data generated through pharmaceutical preformulation and formulation development can support product development for multiple regulatory markets, depending on the study design, applicable guidelines, and specific requirements of the target region. Preformulation data can provide important information about the drug substance, including its physicochemical properties, solubility, stability, particle characteristics, polymorphism, and compatibility with excipients.The exact regulatory suitability depends on the target market, product type, development stage, applicable regulatory guidelines, and study requirements. Therefore, preformulation development can provide a strong scientific foundation for formulation development and help generate relevant data for subsequent regulatory submissions across different markets.
