REFERENCES
- Nebrink O. Characterization of Aerosol Delivery Devices and their Influences and Deposition in Human and Animals. Ph.D. Thesis. Karolinska Institute 2001.
- Niven R W. Delivery of biotherapeutics by inhalation aerosol.Crit Rev Ther Drug Carr Syst 1995; 12:151–231. [CSA]
- Clark A R. Pulmonary delivery technology: recent advances and potential for the new millennium. In: AJ H, ed. Pharmaceutical Inhalation Aerosol Technology. Vol. 134. Marcel Dekker, 2003:571–591.
- Owens D R, Zinman B, Bolli G. Alternative routes of insulin delivery.Diabet Med 2003; 20:886–898. [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
- U.N. United Nations Environment Programme Handbook for the International Treaties for the Protection of the Ozone Layer. Nairobi: Ozone Secretariat, 1996.
- Patridge M R, Woodcock A A. Propellants. In: Bisgard H OCC, Smalldone G, eds. Drug Delivery to the Lung. New York: Marcel Dekker, 2002.
- Committee for Proprietary Medicinal Products (CPMP), European Agency for the Evaluation of Medicinal Products. Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products.November 2000. London: European Medicines Agency, CPMP/QWP/2845/00.
- Committee for Proprietary Medicinal Products (CPMP), European Agency for the Evaluation of Medicinal Products. Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products.November 2000. London CPMP/QWP/2845/00 http://www.emea.eu.int/pdfs/human/qwp/284500en.pdf.
- U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products.December 1998. http://www.fda.gov/cder/guidance/2180dft.pdf.
- DiMasi J A. A new look at united states drug development and approval times.Am J Ther 1996; 3:647–657. [PUBMED], [INFOTRIEVE]
- DiMasi J A. Success rates for new drugs entering clinical testing in the United States.Clin Pharmacol Ther 1995; 58:1–14. [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
- Atkins P J, Crowder T M. Design and development of inhalation drug delivery systems. In: Hickey A, ed. Pharmaceutical Inhalation Aerosol Technology.Vol. 134. Marcel Dekker, 2003:279–309.
- Vanbever R, Mintzes J D, Wang J, Nice J, Chen D, Batycky R, Langer R, Edwards D A. Formulation and physical characterization of large porous particles for inhalation.Pharm Res 1999; 16:1735–1742. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Mayo A, Kompella U B. Supercritical fluid technology in pharmaceutical research. In: Swarbrick J, Boylan J C, eds. Encyclopedia of Pharmaceutical Technology. 2nd ed. New York: Marcel Dekker, 2004:1–15.
- Edwards D A, Hanes J, Caponetti G, Hrkach J, Ben-Jebria A, Eskew M L, Mintzes J, Deaver D, Lotan N, Langer R. Large porous particles for pulmonary drug delivery.Science 1997; 276:1868–1871. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Atkins P. Chlorofluorocarbon to hydrofluoroalkane formulations: an industry perspective.J Allergy Clin Immunol 1999; 104:S268–S270. [PUBMED], [INFOTRIEVE], [CSA]
- Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers.Respir Med 2000; 94(suppl B)S3–S9. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Emmen H H, Hoogendijk E M, Klopping-Ketelaars W A, Muijser H, Duistermaat E, Ravensberg J C, Alexander D J, Borkhataria D, Rusch G M, Schmit B. Human safety and pharmacokinetics of the CFC alternative propellants HFC 134a (1,1,1,2-tetrafluoroethane) and HFC 227 (1,1,1,2,3,3, 3-heptafluoropropane) following whole-body exposure.Regul Toxicol Pharmacol 2000; 32:22–35. [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
- Langley S J, Sykes A P, Batty E P, Masterson C M, Woodcock A. A comparison of the efficacy and tolerability of single doses of HFA 134a albuterol and CFC albuterol in mild-to-moderate asthmatic patients.Ann Allergy, Asthma, & Immun 2002; 88:488–493. [CSA]
- Partridge M, Woodcock A. Metered dose inhalers free of chlorofluorocarbons.BMJ 1995; 310:684–685. [PUBMED], [INFOTRIEVE]
- Miller N C. In: PR B, ed. Respiratory Drug Delivery.CRC Press, 1990:249.
- Concessio N M, van Oort M M, Knowles M R, Hickey A J. Pharmaceutical dry powder aerosols: correlation of powder properties with dose delivery and implications for pharmacodynamic effect.Pharm Res 1999; 16:828–834. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Concessio N M, Hickey A J. Descriptors of irregular particle morphology and powder properties.Adv Drug Deliv Rev 1997; 26:29–40. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Edwards D A, Ben-Jebria A, Langer R. Recent advances in pulmonary drug delivery using large, porous inhaled particles.J Appl Physiol 1998; 85:379–385. [PUBMED], [INFOTRIEVE]
- Musante C J, Schroeter J D, Rosati J A, Crowder T M, Hickey A J, Martonen T B. Factors affecting the deposition of inhaled porous drug particles.J Pharm Sci 2002; 91:1590–1600. [PUBMED], [INFOTRIEVE], [CROSSREF]
- U.S. Department of Health and Human Services (DHHS). Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) Guidance for Industry Inhalation Drug Products Packaged in Semipermeable Container Closure Systems,July 2002. http://www.fda.gov/cder/guidance/4168dft.pdf.
- International Pharmaceutical Aerosol Consortium (IPAC). Comments on a Draft Guidance for IndustryMetered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation (Docket No. 98D-0997),1999.
- Chege J K, El-Araud K A, Clark B J, Chrystyn H. Optimal particle size for aerosols.Thorax 1997; 52:586–587. [PUBMED], [INFOTRIEVE]
- Stein S W. Size distribution measurements of metered dose inhalers using Andersen Mark II cascade impactors.Int J Pharm 1999; 186:43–52. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Stein S W, Olson B A. Variability in size distribution measurements obtained using multiple Andersen Mark II cascade impactors.Pharm Res 1997; 14:1718–1725. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Cyr T D, Duhaime R M, Graham S J, Ormsby E D, Lawrence R C, LeBelle M J. Metered dose inhalers III: metaproterenol sulphate; particle size distribution and dose uniformity.J Pharm Biomed Anal 1997; 15:1709–1718. [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
- Tzou T Z. Aerodynamic particle size of metered-dose inhalers determined by the quartz crystal microbalance and the Andersen cascade impactor.Int J Pharm 1999; 186:71–79. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Kwong W T, Ho S L, Coates A L. Comparison of nebulized particle size distribution with Malvern laser diffraction analyzer versus Andersen cascade impactor and low-flow Marple personal cascade impactor.J Aerosol Med 2000; 13:303–314. [PUBMED], [INFOTRIEVE], [CSA]
- Gard E, Mayer J E, Morrical B D, Dienes T, Fergenson D P, Prather K A. Real-time analysis of individual atmospheric aerosol particles: design and performance of a portable ATOFMS.J Anal Chem 1997; 69:4083–4091. [CROSSREF]
- Stowers M A, van Wuijckhuijse A L, Marijnissen J C, Scarlett B, van Baar B L, Kientz C E. Application of matrix-assisted laser desorption/ionization to on-line aerosol time-of-flight mass spectrometry.Rapid Commun Mass Spectrom 2000; 14:829–833. [PUBMED], [INFOTRIEVE], [CROSSREF]
- Mitchell J P, Nagel M W. Time-of-flight aerodynamic particle size analyzers: their use and limitations for the evaluation of medical aerosols.J Aerosol Med 1999; 12(4)217–240. [PUBMED], [INFOTRIEVE], [CSA]
- Mitchell J P, Nagel M W, Archer A D. Size analysis of a pressurized metered dose inhaler-delivered suspension formulation by the API Aerosizer time-of-flight aerodynamic particle size analyzer.Aerosol Med 1999; 12(4)255–264. [CSA]
- ITFG/IPAC Collaboration. CMC Specifications Particle Size Distribution Working Group: Initial Assessment of the ITFG/IPAC Aerodynamic Particle Size Distribution Database.2000. http://www.ipacrs.com/PDFs/Initial_Assess_of_Particle.PDF.
- The Product Quality Research Institute (PQRI). Particle Size Distribution Mass Balance Working Group: Considerations for the Development and Practice of Cascade Impaction Testing Including a Mass Balance Failure Investigation Tree,2002. http://www.pqri.org/survey/imagespdfs/GCIP(v1).pdf.
- Williams R L, Adams W P, Poochikian G, Hauck W W. Content uniformity and dose uniformity: current approaches, statistical analyses, and presentation of an alternative approach, with special reference to oral inhalation and nasal drug products.Pharm Res 2002; 19:359–366. [PUBMED], [INFOTRIEVE], [CROSSREF]
- ITFG/IPAC Collaboration. CMC Specifications Technical Team: Initial Assessment of the ITFG/IPAC Dose Content Uniformity Database,2000. http://www.ipacrs.com/PDFs/Initial_Assessment_of_Dose.PDF.
- 〈905〉, Uniformity of dosage units, content uniformity, U.S. Pharmacopeia, United States Pharmacopeial Convention, Rockville, Maryland, 2000:2702–2704, 24th rev., suppl. 1.
- IPAC-RS. Dose Content Uniformity Working Group 2001: A Parametric Tolerance Interval Test for Improved Control of Delivered Dose Uniformity for Orally Inhaled and Nasal Drug Products. http://www.ipacrs.com/PDFs/IPAC-RS_DDU_Proposal.PDF.
- U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER): Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing, and Controls Documentation.May 1999. http://www.fda.gov/cder/guidance/1714fnl.htm.
- ITFG/IPAC-RS Collaboration. CMC Leachables and Extractables Technical Team 2001. Leachables and Extractables Testing: Points to Consider. http://www.ipacrs.com/PDFs/Points_to_Consider_FINAL.PDF.
- ITFG/IPAC-RS Collaboration, CMC Tests and Methods Technical Team 2001. Recommendations for Tests and Methods. http://www.ipacrs.com/PDFs/Recommendations_for.PDF.