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Table 1 Overview of case studies

From: Utilization of risk-based predictive stability within regulatory submissions; industry’s experience

Case study no.DescriptionPhaseMaterialSubmission Content in Addition to Predictive DataaTerritories
AcceptedQuestioned
1Setting initial retest period and shelf-lifePhase 1Drug substance and oral solutionLimited long-term data for drug substanceBelgium 
2Setting shelf-life of formulation variantPhase 1TabletLimited long-term dataUSA, UK, France, Italy, Turkey, Egypt, Lebanon, Kenya 
3Setting shelf-life of formulation variantPhase 1CapsuleLimited long-term dataUSA 
4Setting initial retest period and shelf-lifePhase 1Drug substance and IV solutionNoneNetherlands, Germany (drug substance)UK, Germany (drug product)
5Setting initial retest period and shelf-lifePhase 1Drug substance and tabletNoneUSAUK
6Setting initial shelf-lifePhase 1TabletNoneBelgium, Moldova, Bulgaria, GeorgiaFrance, Spain
7Setting initial shelf-lifePhase 1Powder for oral solution and tabletNone Germany
8Setting shelf-life of formulation variantPhase 1CapsuleNoneUSA, Spain, France 
9Setting initial shelf-lifePhase 2TabletsNoneUSA, Belgium 
10Setting initial shelf-lifePhase 2Modified release formulationNoneUSA, Belgium 
11Setting shelf-life of formulation variantPhase 2TabletNoneUSA, Spain, FranceGermany
12Justify storage condition for drug substance with a new process, and predict shelf-life for a new formulationPhase 2Drug Substance and TabletLimited long-term data for drug substance, Limited long-term data for drug productUSA 
13Setting shelf-life of formulation variantPhase 2TabletLimited long-term dataUK (but with reduced shelf-life) 
14Impact of drug product process change on shelf-lifePhase 3TabletLimited long-term dataUSA, Canada, Russia, Taiwan, Poland, Ukraine, Japan 
15Setting shelf-life of formulation variantPhase 3CapsuleSupportive information from previous formulationsBelgium, Brazil, Canada, China, India, Denmark. Finland, France, Ireland, Italy, Netherlands, Portugal, Spain, Taiwan, TurkeyUK, Korea, Germany
16Justification of strategy for water testing on stabilityRegistrationTabletPredictive dissolution modelUSA, EU 
17Justification of degradant end of life specificationRegistrationTabletLimited long-term dataUSA, EU, Canada, Australia, Asia Pacific and Latin America 
  1. aDoes not reflect additional data provided in response to regulatory queries