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Overview2• EPAG, what is it?, background, this project…• Regulatory guidance• Pharmacopeial guidance• What current in-vitro testing methods can and can nottell us• Defining mass fraction penetrating the nasopharynx• Methods applied and results to date for % particles
EPAG, what is it?, background, this project…3• EPAG Organisation (European PharmaceuticalAerosol Group)• Voluntary organisation• Self managed• Annual fee (non-profit making basis), Funding studies, experts etc• Rules & Constitution• EPAG Membership, current Feb 2010• 3M, Almirall Sofotec, AstraZeneca, Bespak Europe Ltd, Boehringer Ingelheim, Chiesi,Clinical Designs Ltd, GlaxoSmithKline, Hovione, Novartis, Pari, Pfizer, sanofi-aventis,Siegfried Pharma Development, SkyePharma, Teva, Trudell Medical International,Valois, Vectura
Page 1: 1EPAG Perspective - RegulatoryAdvan
Page 5 and 6: EPAG, what is it?, background, this
Page 7 and 8: REGULATORY: Heath Canada-EMEA7• H
Page 9 and 10: REGULATORY: Heath Canada-EMEA9Pharm
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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