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Quality by Design (QbD) is a well-known pharmaceutical industry strategy for enhancing production processes, including active pharmaceutical ingredients and medicinal products. Companies…
Characterizing an API’s different salt forms and polymorphs is an essential drug development task. The successful preclinical assessment and product development can…
A newly formed pharmaceutical company was creating a novel cardiometabolic drug, a new small molecule, that was in Phase 2a testing in…
If scientific literature indicates that elements are not likely to be present in drug product components, and no additional elements are added…
It is typical to encounter a restricted number of APIs during the initial stages of drug development. This limitation hinders the swift…