Dissolution and drug release tests are directly relevant to the safety and efficacy of many common pharmaceutical dosage forms. To achieve reliable and reproducible results, analysts must understand ...
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 – ...
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