When you take a time-release drug, you count on it doing what the package says: release the drug slowly into your bloodstream to provide benefits over the specified period of time. When the drug ...

Low-dose dissolution frequently demands reduced media volumes to keep early time-point concentrations above LOQ, and regulators may expect evaluation of higher-sensitivity analytics before lowering ...

Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...