API screening is the initial step in the process of identifying and analyzing the properties of an active pharmaceutical ingredient (API). The goal of API screening is to test a number of different API candidates to determine which one is most suitable for further development. This may involve testing the API's effectiveness at treating a specific condition, as well as assessing its potential side effects. Depending on the stage of development, the screening process may involve in vitro and in vivo studies using cell cultures or animal models.

Characterization is the next step in the API development process, in which the selected API is analyzed in more detail to determine its chemical and physical properties. This may include testing the API's purity, stability, and solubility. The characterization process helps to ensure that the API is suitable for use in a specific product and that it meets safety and efficacy requirements. It may also involve studying the API's pharmacokinetics and pharmacodynamics.

API characterization data is critical for regulatory approval, as it helps to demonstrate the safety and efficacy of a drug candidate. It also helps to identify potential risks and guide the formulation and manufacturing of the drug product. Additionally, API characterization helps to establish the appropriate storage conditions, handling and administration instructions, and shelf life of the final product.

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