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Global Long Term Stability Testing Conditions: …
Global long Term Stability Testing conditions : position of INDIAS aranjit Singh, Institute of Pharmaceutical Education and Research (NIPER), SAS NagarThe towering importance of long -term Stability Test ConditionsAccording to latest guidelinesExpiry date is determined from long -Term Stability Test DataAccelerated data considered only supportiveExpiry Date Calculations from long -term Data based on 95% Confidence LimitsExpiry dateFrom where did this concept arise?US FDA Guidance of 1987 Historical Perspective of the Development of Global Storage ConditionsThe Development of Concept of Zones Major contribution: Dr Wolfgang GrimmThe zone conceptRegionZone I and II countriesZone III and IV countriesEuropeAll countries------AmericaArgentina, Bolivia, Chile, Canada, Mexico, Peru, Uruguay, USAB arbados, Belize, Brazil, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Guyana, Haita, Honduras, Jamaica, Columbia, Cuba, Nicaragua, Dutch Antilles, Panama, Paraguay, Puerto Rico, Venezuela.
Global Long Term Stability Testing Conditions: Position of INDIA Saranjit Singh, Ph.D. National Institute of Pharmaceutical Education and Research (NIPER),
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