WHO稳性试验指南专家讲座.pptxVIP

Stabilitytestingof

activepharmaceuticalingredients

and

finishedpharmaceuticalproducts第1页

WHO——StabilityTestingofActivePharmaceuticalIngredients(APIs)andFinishedPharmaceuticalProducts(FPPs)Q1A——StabilityTestingofNewDrugSubstancesandProducts第2页

1Introduction2FinishedPharmaceuticalProducts(FPPs)3ActivePharmaceuticalIngredients(APIs)主要内容第3页

1.Introduction

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1.1Objectivesoftheseguidelines为药品活性成份和制剂成品申报所需稳定性试验数据提供例证。ICHQ1AForaregistrationapplicationwithinthethreeregionsoftheEC,Japan,andtheUnitedStates.Itdoesnotseeknecessarilytocoverth