Points to Consider when Establishing Drug Product Specifications for Parenteral Microspheres
Journal Title: The AAPS Journal - Year 2010, Vol 12, Issue 1
Abstract
Drug product specifications are a critical element of a good control strategy. Parenteral microsphere products are complex dosage forms, requiring careful development of test methods and acceptance criteria for the specifications. In particular, the in vitro release test method and acceptance criteria require rigorous scientific consideration and should be developed with an eye toward understanding the mechanisms of drug release. The final specifications need to ensure the safety, identity, strength, performance, and quality of the drug product at release and during storage through the end of its shelf-life. The specification limits are typically established based upon regulatory guidance, available data from the manufacturing process (process capability), from non-clinical, clinical, and stability studies.
Authors and Affiliations
Rajesh Kumar, Michael J. Palmieri, Jr
Keywords
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