Description
Pre-preparation studies were initiated prior to the commencement of pharmaceutical preparation activities. In the pre-preparation stage, the physical and chemical properties of the active drug component (API) were determined. For chemical API, the knowledge gained will help you choose the correct salt or polymorphism form and will support the design and development of your dosage form, both preclinical and clinical use. For bioactive drugs, pre-prescription studies ensure that the best candidates for CMC characteristics are selected, which will prove useful in further drug product development. In addition, during the pre-prescription study, the relevant analytical methods can be optimized for use at a later stage of drug product development.