Download - Aptar

More documents

Recommendations

Info

Developing technology with API specificity24• LD, though versatile, does notprovide chemical speciesidentification linked to thedroplet PSD:• A problem for multicomponentformulations• …or where non-activeexcipient(s) are present• …or even with singlecomponent, suspension APIs
Raman chemical imaging25• Raman shifts specific to API(s) excipients etc. enablechemical composition of particles imaged to bedisplayed in a quantitative mannerOptical imageAPI identified by colourcourtesy J.D. Suman, Nextbreath LLC
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 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: Time averaged v-PSD23• Capable of
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

Create successful ePaper yourself

Delete template?

Save as template?