Formulation Development Studies for Sterile Dosages: A Comprehensive Review
Abstract
Sterile generic dosage development requires that specific critical quality attributes be considered and evaluated, regardless of the route of delivery or the type of registration application. The review briefed with an overview of Pharmaceutical Development study requirements. Each of the various stages of studies like Compatibility with the packaging materials, manufacturing vessels, processing aids, MOCs, Filters, Tubing’s and Gaskets also with special studies to be conducted as part of Regulatory Submission, process considerations. Thus, the chapter offers the formulator an overview of the foundational principles associated with formulation development /Pre-formulation studies of sterile products.
Keywords: Pharmaceutical Development, Compatibility, Studies, Hold time.
Keywords:
Pharmaceutical Development, Compatibility, Studies, Hold timeDOI
https://doi.org/10.22270/jddt.v11i3.4743References
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