Regulation of impurities in drug substances and products

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Q3C, Impurities: Guideline for RResidual id l SSolvents, l t Ri Risk k AAssessment t ffo Class Cass2 Solvents So e s F5 = a factor applied if the no-effect level was not established tblihd F5 = 10 when only ya LOEL is available, and depending p gon the severity of the toxicity. Food and Drug Administration No Effect
Q3C, Impurities: Guideline for RResidual id l SSolvents, l t Ri Risk k Assessment for Class 2 Solvents: xylene The PDE for xylene is 21.7 mg/day This implied precision goes far beyond the precision of the science used to calculate it! Food and Drug Administration
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Page 3 and 4: Steps in any Risk Assessment Hazar
Page 5 and 6: Steps in any Risk Assessment Expos
Page 7 and 8: Relevant guidelines, publications a
Page 9 and 10: Q3A(R) Q3A(R), Impurities in New Dr
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Page 13 and 14: Are qualification assays sufficient
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Page 17 and 18: Q3B(R) Impurities in new drug produ
Page 23 and 24: Detection of genotoxic impurities
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Page 37: Do we have a science-based approach

Regulation of impurities in drug substances and products

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