Drug Substance Postapproval Changes Guidance: Determination of Impurity Profile Equivalence
Вставка
- Опубліковано 7 вер 2024
- FDA discusses an overview of the assessment of risk factors with respect to the control of impurities and recommendations for documenting the risk-based determination.
Presenter:
Brian Connell, Division of Lifecycle API
Learn more at: www.fda.gov/dr...
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