Download - Aptar

More documents

Recommendations

Info

EPAG, what is it?, background, this project…6• This project…,• European pharmacopeia methodology for Nasal sprays• Aerodynamic particle size analysis of two fractions. (< 10µm >)• Methodology produces data as representative as possible of the sprayexiting the device orifice• Method validation package
REGULATORY: Heath Canada-EMEA7• Heath Canada-EMEA:– Joint Guideline on the Pharmaceutical Quality ofInhalation and Nasal Products– EMEA/CHMP/QWP/49313/2005 Corr - Section 4.2.2• The tests indicated in Table 4.2.2 are normallyconducted to characterize nasal products– Not all tests are necessary for all types of nasal products(see guideline for details)
Page 1 and 2: 1EPAG Perspective - RegulatoryAdvan
Page 3 and 4: EPAG, what is it?, background, this
Page 5: EPAG, what is it?, background, this
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

Download - Aptar

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?