Critical API Attributes And The Major Impact They Can Have On Drug Product Development
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Critical API Attributes And The Major Impact They Can Have On Drug Product Development

Chemical process development of an active pharmaceutical ingredient (API) or drug substance and the pharmaceutical development of the final, formulated drug product from this API are frequently treated as independent activities in the overall process of developing a new drug. However, this independent approach can lead to challenges such as an API that is difficult to handle or requires additional processing before manufacturing the final formulation. An integrated approach to product development can serve to avoid common pitfalls and focus efforts to where real issues exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product. This white paper covers API properties and their impact upon formulation, a smart approach to product development, and more. Download now to learn more.

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