Drug product release support, analytical

Regulatory specifications may differ from product release specifications. Regulatory specifications assure acceptable product potency until the labeled expiration date or shelf life. In general, in-house release specifications are tighter than regulatory specifications. Refer to the Guideline for Submission of Supportive Analytical Data for Methods Validation in the New Drug Application. 

Prior to developing a drug product, a number of experiments need to be conducted that will fully characterize the API. This information will then be used to help guide formulation development efforts. Each of the critical pieces of information that are needed for formulation development will be discussed below. These include a screening process where an ideal soHd-state salt form is selected and the generation of a suite of analytical methods necessary to probe the critical quality attributes of the new chemical entity, to support synthetic optimization scale-up, stability studies, and the release of material for GLP and experimental use. 

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