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Approaching product launch, decisions need to be made on specifications for API and drug product.  Additionally changes in the manufacturing process, even if minor on the surface, can significantly impact material properties of your API and drug product.  These manufacturing changes often lead to out of specification results tied to API form or particle attributes.

Activities related to solid state properties in late clinical development include:

     •     Crystallization optimization

               •  Impact of scale or manufacturing changes on particle form or attributes

     •     Property assessment for regulatory filing

     •     Out of specification investigations

          •   Dissolution changes caused by API form or particle attributes?

     •     Full understand of crystal form space in API and Drug Product

     •     Setting of specifications

          •     Particle size?  Form?