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US Regulatory requirements10• USFDA (CDER):• July 2002: Guidance for Industry - Nasal Sprayand Inhalation Solution, Suspension, and SprayDrug Products — CMC Documentation• April 2003: Draft Guidance for Industry -Bioavailability and Bioequivalence Studies forNasal Aerosols and Nasal Sprays for Local Action
CMC documentation: Nasal sprays11Description Identification AssayImpurities andDegradation ProductsSpray ContentUniformityPreservatives and PumpDeliveryStabilizing ExcipientsAssaySpray Pattern andPlume GeometryPump DeliveryDroplet SizeDistributionParticle Size Distribution(Suspensions)Particulate MatterMicrobial LimitsNet Content Weight Loss (Stability) Leachables (Stability)pH Osmolality Viscosity
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 and 8: REGULATORY: Heath Canada-EMEA7• H
Page 9: REGULATORY: Heath Canada-EMEA9Pharm
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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