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2. Nichols SC, Mitchell JP. A rational approach to cascade impactor mensuration in a good cascade impactor practice (GCIP) environment. Pharm Forum. 2014;40(1). www. uspnf.com/pharmacopeial-forum. Accessed May 5, 2018. 3. Mitchell J, Sandell D, Suggett J, Christopher JD, Leiner S, Walfish S, Curry P, Zaidi K. Proposals for data interpretation in the context of determination of aerodynamic particle size distribution profile for orally inhaled products. Pharm Forum. 2017;43(3). www.uspnf.com/pharmacopeial-forum. Accessed June 25, 2018. 4. European Directorate for the Quality of Medicines (EDQM). Preparations for nebulization. European Pharma- copeia, 9th ed. Strasbourg, France: EDQM. 5. International Standards Organization (ISO). Anaesthetic and respiratory equipment—Nebulizing systems and compo- nents. ISO 27427:2013. 6. European Committee for Standardisation (CEN). Respira- tory therapy equipment—Part 1: Nebulising systems and their components. Ref: EN 13544-1:2006. 7. Canadian Standards Association (CSA). Spacers and hold- ing chambers for use with metered-dose inhalers. Ref: Z264.1-02:2008. 8. Marple VA, Olson BA, Santhanakrishnan K, Roberts DL, Mitchell J, Hudson-Curtis BL. Next generation pharmaceuti- cal impactor: A new impactor for pharmaceutical inhaler test- ing. Part III. Extension of archival calibration to 15 L/min. J Aerosol Med. 2004; 17(4):335-343. 9. Dennis J, Berg E, Sandell D, Ali A, Lamb P, Tservistas M, Karlsson M, Mitchell J. Cooling the NGI—An approach to size a nebulised aerosol more accurately. Pharmeur Sci Notes. 2008;2008(1):27-30. 10. Stapleton KW, Finlay WH. Undersizing of droplets from a vented nebulizer caused by aerosol heating during transit through an Anderson impactor. J Aerosol Sci. 1999;30(1):105-109. 11. Mitchell JP, Poochikian G, Hickey AJ, Suggett J, Curry PD, Tougas TP, Zaidi K. In vitro assessment of spacers and valved holding chambers used with pressurized metered-dose inhalers: e need for a USP chapter with clinically relevant test methods. Pharm Forum. 2011;37(4). www.uspnf.com/ pharmacopeial-forum. Accessed June 25, 2018. 12. Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL. American College of Chest Physicians; American College of Asthma, Allergy and Immunology. Device selec- tion and outcomes of aerosol therapy: Evidence-based guide- lines. Chest. 2005;127(1):335-371. 13. Esposito‐Festen J, Ates B, van Vliet F, Hop W, Tiddens H. Aerosol delivery to young children by pMDI‐spacer: Is face- mask design important? Pediatr Allergy Immunol. 2005;16(4):348-353. 14. Mitchell JP, Dolovich MB. Clinically relevant test methods to establish in vitro equivalence for spacers and valved holding chambers used with pressurized metered dose inhalers (pMDIs). J Aerosol Med Pulm Drug Deliv. 2012;25(4):217-242. 15. Christopher D, Curry P, Doub B, Furnkranz K, Lavery M, Lin K, Lyapustina S, Mitchell J, Rogers B, Strickland H, Tou- gas T, Tsong T, Wyka B. PQRI Particle Size Distribution Mass Balance Working Group. Considerations for the develop- ment and practice of cascade impaction testing including a mass balance failure investigation tree. J Aerosol Med. 2003;16(3):235-247. 16. Nichols SC, Mitchell JP, Shelton CM, Roberts DL. Good cascade impactor practice (GCIP) and considerations for " i n - u s e " s p e c i f i c a t i o n s . A A P S P h a r m S c i Te c h . 2013;14(1):375-390. 17. Nichols SC, Mitchell JP. A rational approach to cascade impactor mensuration in a good cascade impactor practice (GCIP) environment. Pharm Forum. 2015;41(4). www. uspnf.com/pharmacopeial-forum. Accessed June 25, 2018. 18. Roberts DL. eory of multi-nozzle impactor stages and the interpretation of stage mensuration data. Aerosol Sci Technol. 2009;43(11):1119-1129. 19. US Food and Drug Administration (FDA). FDA Guid- ance for Industry: Metered dose inhaler (MDI) and dry pow- der inhaler (DPI) products—Quality considerations. Draft Guidance, Revision 1 (April 2018). www.fda.gov/downloads/ drugs/guidances/ucm070573.pdf. Accessed June 25, 2018. e relationship between the United States Phar- macopeial Convention (USP) and the US Food and Drug Administration (FDA) dates back to the 1906 Pure Food and Drug Act, which deemed the United States Pharmacopeia and the National Formulary official compendia under federal law. For more information about the relationship between the FDA and USP, please visit: http:// www.usp.org/about/public-policy/usp-fda-roles. Kahkashan Zaidi, PhD; Paul Curry, PhD; Anthony J. Hickey, PhD, DSc; Stefan Leiner, PhD; Jolyon P. Mitchell, PhD; Guirag Poochikian, PhD and Jason Suggett, PhD are members of the Aerosols Sub-Committee of the General Chapters–Dosage Forms Expert Committee, United States Pharmacopeial Convention (USP), Rockville, Maryland, US. Corresponding author: Kahkashan Zaidi, PhD, Principal Scientific Liaison, General Chapters, USP, 12601 Twinbrook Parkway, Rockville, MD, 20852, US. Tel.: +1 (301) 816-8269, E-mail: kxz@usp.org. To read the first article in this two-part series, "An over- view of general chapter development for oral and nasal drug products (OINDPs) at the US Pharmacopeia (USP): Part 1–Normative chapters <5>, <601>, <602>, <603> and <604>," please visit the Inhalation home page or article archive. Inhalation December 2018 19