Inhalation

INH0616

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Industry. Nasal Spray and Inhalation Solution, Suspen- sion, and Spray Drug Products—Chemistry, Manufac- turing, and Controls Documentation. (2002). Available at: http://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/ucm07 0575.pdf. 8. US Food and Drug Adminstration. Draft Guidance for Industry. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action. (2003). Available at: http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070111.pdf. 9. European Medicines Agency. Guideline on the Phar- maceutical Quality of Inhalation and Nasal Products (2005). Available at: http://www.ema.europa.eu/ docs/en_GB/document_library/Scientific_guideline/2 009/09/WC500003568.pdf. 10. AAMI/ANSI HE75 (2009), Human Factors Engi- neering—Design of Medical Devices. 11. Hearnden, V, et al., New Developments and Opportunities in Oral Mucosal Drug Delivery for Local and Systemic Disease. Adv Drug Deliver Rev, 64, 16- 28, 2012. 12. Wikipedia, Subligual administration. Available at: https://en.wikipedia.org/wiki/Sublingual_administration. Gerallt Williams is Director of Scientific Affairs at Aptar Pharma, Prescription Division, Route des Falaises 27100 Le Vaudreuil Cedex, France, Tel: +33 2 32 63 73 73, gerallt.williams@aptar.com. Website: www.aptar.com/ pharma. w ww asia2016 .com/ e n i nl o dd r . w i l d a e D 2016 6 1 0 2 June 24, : e n Inhalation JUNE 2016 15

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