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REGULATORY: Heath Canada-EMEA8• Covers 6 distinct categories of nasal delivery devicePressurizedmetered dosenasal spraysNasal powders(devicemetered)Nasal liquidsSingle usedropsMultiple usedropsSingle usespraysNonpressurizedmultiple usemetered dosesprays
REGULATORY: Heath Canada-EMEA9Pharmaceutical development studiesPhysical characterizationMinimum fill justificationExtractables/leachablesDelivered dose uniformity through container lifeParticle/droplet size distributionActuator depositionShaking requirementsInitial & re-priming requirementsCleaning requirementsLow temperature performancePerformance after temperature cyclingEffect of environmental moisturerobustnessDelivery device development
Page 1 and 2: 1EPAG Perspective - RegulatoryAdvan
Page 3 and 4: EPAG, what is it?, background, this
Page 5 and 6: EPAG, what is it?, background, this
Page 7: REGULATORY: Heath Canada-EMEA7• H
Page 11 and 12: CMC documentation: Nasal sprays11De
Page 13 and 14: Draft Nasal BA/BE guidance …13Sin
Page 15 and 16: What current in-vitro methods can a
Page 17 and 18: Define standard entry port17• Dou
Page 19 and 20: Nasal induction port design19Work i
Page 21 and 22: Size, characterizing the entire dos
Page 23 and 24: Time averaged v-PSD23• Capable of
Page 25 and 26: Raman chemical imaging25• Raman s
Page 27 and 28: Challenges….27• Identify suitab
Page 29 and 30: Results to date….29Inverted NGI&
Page 31: Acknowledgments and thanks to ….3

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