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Volumn 23, Issue 1, 2010, Pages 1-29

Demonstrating bioequivalence of locally acting orally inhaled drug products (OIPs): Workshop summary report

(30)  Adams, Wallace P a   Ahrens, Richard C b   Chen, Mei Ling a   Christopher, David c   Chowdhury, Badrul A a   Conner, Dale P a   Dalby, Richard d   Fitzgerald, Kevin e   Hendeles, Leslie f   Hickey, Anthony J g   Hochhaus, Günther h   Laube, Beth L i   Lucas, Paul j   Lee, Sau L a   Lyapustina, Svetlana k   Li, Bing a   O'Connor, Dennis l   Parikh, Neil m   Parkins, David A n   Peri, Prasad a   more..


Author keywords

[No Author keywords available]

Indexed keywords

BECLOMETASONE DIPROPIONATE; BUDESONIDE; CORTICOSTEROID; FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; FORMOTEROL; FORMOTEROL FUMARATE; MOMETASONE FUROATE; NITRIC OXIDE; SALBUTAMOL; SALMETEROL;

EID: 76649105779     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2009.0803     Document Type: Conference Paper
Times cited : (65)

References (97)
  • 1
    • 2542465496 scopus 로고    scopus 로고
    • U.S. Department of Health andHumanSevices (DHHS), March, Available at
    • U.S. Department of Health andHumanSevices (DHHS), Food and Drug Administration (FDA): Innovation or Stagnation. March 2004. Available at: http://www.fda.gov//downloads// ScienceResearch//SpecialTopics// CriticalPathInitiative//Critical PathOpportunitiesReports//ucm113411.pdf
    • (2004) Food and Drug Administration (FDA): Innovation or Stagnation
  • 2
    • 76649103966 scopus 로고    scopus 로고
    • DHHS, Center for Drug Evaluation and Research (CDER), FDA, Office of Pharmaceutical Science (OPS), 1 May Available at
    • DHHS, Center for Drug Evaluation and Research (CDER), FDA, Office of Pharmaceutical Science (OPS), Office of Generic Drugs (OGD): Critical Path Opportunities for Generic Drugs. 1 May 2007. Available at: http://www.fda.gov// ScienceResearch//SpecialTopics//CriticalPathInitiative//Critical Path OpportunitiesReports//ucm077250.htm
    • (2007) Office of Generic Drugs (OGD): Critical Path Opportunities for Generic Drugs
  • 3
    • 33846705925 scopus 로고    scopus 로고
    • Product quality research institute reports
    • Article 6
    • DeLuca PP, and Lyapustina S: Product quality research institute reports. AAPS PharmSciTech. 2007;8:Article 6.
    • (2007) AAPS PharmSciTech , vol.8
    • Deluca, P.P.1    Lyapustina, S.2
  • 4
    • 33846652603 scopus 로고    scopus 로고
    • Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols Part 1: Background for a statistical method
    • Article 4
    • Adams WP, Christopher D, Lee DS, Morgan B, Pan Z, Singh GJP, Tsong Y, and Lyapustina S: Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, Part 1: background for a statistical method. AAPS PharmSciTech. 2007;8:Article 4.
    • (2007) AAPS PharmSci Tech , vol.8
    • Adams, W.P.1    Christopher, D.2    Lee, D.S.3    Morgan, B.4    Pan, Z.5    Singh, G.J.P.6    Tsong, Y.7    Lyapustina, S.8
  • 5
    • 36949015610 scopus 로고    scopus 로고
    • Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: Part 2-evaluation of a method for determining equivalence
    • Article 5
    • Christopher D, Adams WP, Lee DS, Morgan B, Pan Z, Singh GJP, Tsong Y, and Lyapustina S: Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: part 2-evaluation of a method for determining equivalence. AAPS PharmSciTech. 2007;8:Article 5.
    • (2007) AAPS PharmSciTech , vol.8
    • Christopher, D.1    Adams, W.P.2    Lee, D.S.3    Morgan, B.4    Pan, Z.5    Singh, G.J.P.6    Tsong, Y.7    Lyapustina, S.8
  • 10
    • 0034929135 scopus 로고    scopus 로고
    • Dose-response relationship and reproducibility of the fall in exhaled nitric oxide after inhaled beclomethasone dipropionate therapy in asthma patients
    • Silkoff PE, McClean P, Spino M, Erlich L, Slutsky AS, and Zamel N: Dose-response relationship and reproducibility of the fall in exhaled nitric oxide after inhaled beclomethasone dipropionate therapy in asthma patients. Chest. 2001; 119:1322-1328.
    • (2001) Chest , vol.119 , pp. 1322-1328
    • Silkoff, P.E.1    McClean, P.2    Spino, M.3    Erlich, L.4    Slutsky, A.S.5    Zamel, N.6
  • 11
    • 0038240597 scopus 로고    scopus 로고
    • Effects of fluticasone plus salmeterol versus twice the dose of fluticasone in asthmatic patients
    • Currie GP, Bates CE, Lee DKC, Jackson CM, and Lipworth BJ: Effects of fluticasone plus salmeterol versus twice the dose of fluticasone in asthmatic patients. Eur J Clin Pharmacol. 2003;59:11-15.
    • (2003) Eur J Clin Pharmacol , vol.59 , pp. 11-15
    • Currie, G.P.1    Bates, C.E.2    Lee, D.K.C.3    Jackson, C.M.4    Lipworth, B.J.5
  • 13
    • 0035991299 scopus 로고    scopus 로고
    • Pasqualoni B and Bufler P: Changes of exhaled nitric oxide during steroid treatment of childhood asthma
    • Beck-Ripp J, Griese M, Arenz S, Köring C, Pasqualoni B, and Bufler P: Changes of exhaled nitric oxide during steroid treatment of childhood asthma. Eur Respir J. 2002;19:1015-1019.
    • (2002) Eur Respir J , vol.19 , pp. 1015-1019
    • Beck-Ripp, J.1    Griese, M.2    Arenz Köring, S.C.3
  • 14
    • 17644363081 scopus 로고    scopus 로고
    • ATS//ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005
    • American Thoracic Society
    • American Thoracic Society: ATS//ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Resp Crit Care Med. 2005;171:912-930.
    • (2005) Am J Resp Crit Care Med , vol.171 , pp. 912-930
  • 16
    • 76649106344 scopus 로고    scopus 로고
    • Asthma stability model for inhaled corticosteroid Dose-response. Topic 3: Use of inhaled corticosteroid dose response as a means to establish bioequivalence of inhalation drug products
    • Rockville, MD, July 23
    • Adams WP: Asthma Stability Model For Inhaled Corticosteroid Dose-Response. Topic 3: Use of Inhaled Corticosteroid Dose Response as a Means to Establish Bioequivalence of Inhalation Drug Products. FDA//CDER//Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. Rockville, MD, July 23, 2008.
    • (2008) FDA//CDER//Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
    • Adams, W.P.1
  • 21
    • 0028086190 scopus 로고
    • Critical aspects of the function of inspiratory flow driven inhalers
    • Olsson B, and Asking L: Critical aspects of the function of inspiratory flow driven inhalers. J Aerosol Med. 1994; 7(Suppl 1):S43-S47.
    • (1994) J Aerosol Med , vol.7 , Issue.SUPPL. 1
    • Olsson, B.1    Asking, L.2
  • 22
    • 45949112470 scopus 로고    scopus 로고
    • Vitro//in vivo comparisons in pulmonary drug delivery
    • Newman SP, and Chan H-K: In vitro//in vivo comparisons in pulmonary drug delivery. J Aerosol Med Pulm Drug Deliv. 2008;21:77-84.
    • (2008) J Aerosol Med Pulm Drug Deliv , vol.21 , pp. 77-84
    • Newman, S.P.1    Chan, H.-K.2
  • 23
    • 69249231628 scopus 로고    scopus 로고
    • Validated three dimensional CFD modeling of aerosol drug deposition in humans-influence of disease and breathing regimes
    • RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Book 1. Davis Healthcare, River Grove, IL
    • Apiou-Sbirlea G, Simoes-Pichelin M, Caillibotte G, Katz I, Texereau J, Fleming J, Conway J, Scheuch G, and Martonen T: Validated three dimensional CFD modeling of aerosol drug deposition in humans-influence of disease and breathing regimes. In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Respiratory Drug Delivery 2008, Book 1. Davis Healthcare, River Grove, IL; pp. 185-195, 2008.
    • (2008) Respiratory Drug Delivery 2008 , pp. 185-195
    • Apiou-Sbirlea, G.1    Simoes-Pichelin, M.2    Caillibotte, G.3    Katz, I.4    Texereau, J.5    Fleming, J.6    Conway, J.7    Scheuch, G.8    Martonen, T.9
  • 24
    • 62149094354 scopus 로고    scopus 로고
    • Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 mg and fluticasone propionate 250 mg: Implications for establishing bioequivalence of inhaled products
    • Daley-Yates PT, Parkins DA, Thomas MJ, Gillett B, House, KW, and Ortega HG: Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 mg and fluticasone propionate 250 mg: implications for establishing bioequivalence of inhaled products. Clin Ther. 2009;31:370-385.
    • (2009) Clin Ther , vol.31 , pp. 370-385
    • Daley-Yates, P.T.1    Parkins, D.A.2    Thomas, M.J.3    Gillett, B.4    House, K.W.5    Ortega, H.G.6
  • 25
    • 0034862979 scopus 로고    scopus 로고
    • Mouthpiece diameter affects deposition efficiency in cast models of the human oral airways
    • Lin T-C, Breysse PN, Laube BL, and Swift DL: Mouthpiece diameter affects deposition efficiency in cast models of the human oral airways. J Aerosol Med. 2001;14:335-341.
    • (2001) J Aerosol Med , vol.14 , pp. 335-341
    • Lin, T.-C.1    Breysse, P.N.2    Laube, B.L.3    Swift, D.L.4
  • 26
    • 29744453224 scopus 로고    scopus 로고
    • Problems with inhaler use: A call for improved clinician and patient education
    • Fink JB, and Rubin BK: Problems with inhaler use: A call for improved clinician and patient education. Respir Care. 2005;50:1360-1374.
    • (2005) Respir Care , vol.50 , pp. 1360-1374
    • Fink, J.B.1    Rubin, B.K.2
  • 27
    • 0141540767 scopus 로고    scopus 로고
    • Assessment of handling of inhaler devices in real life: An observational study in 3811 patients in primary care
    • Molimard M, Raherison C, Lignot,S, Depont F, Abouelfath A, and Moore N: Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. 2003;16:249-254.
    • (2003) J Aerosol Med , vol.16 , pp. 249-254
    • Molimard, M.1    Raherison, C.2    Lignot, S.3    Depont, F.4    Abouelfath, A.5    Moore, N.6
  • 29
    • 41749097460 scopus 로고    scopus 로고
    • Inhalatory therapy training: A priority challenge for the physician
    • Melani AS: Inhalatory therapy training: a priority challenge for the physician. Acta Biomed. 2007;78:233-245.
    • (2007) Acta Biomed , vol.78 , pp. 233-245
    • Melani, A.S.1
  • 34
    • 76649140773 scopus 로고    scopus 로고
    • US perspectives on the equivalence of ICS
    • RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Book 1. Davis Healthcare International Publishing, River Grove, IL
    • Chowdhury B: US perspectives on the equivalence of ICS. In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Respiratory Drug Delivery 2008, Book 1. Davis Healthcare International Publishing, River Grove, IL; pp. 148-150, 2008.
    • (2008) Respiratory Drug Delivery 2008 , pp. 148-150
    • Chowdhury, B.1
  • 36
    • 0025309316 scopus 로고
    • Formoterol, a new long-acting selective b2-agonist, decreases airway responsiveness in children with asthma
    • Becker AB, and Simons FE: Formoterol, a new long-acting selective b2-agonist, decreases airway responsiveness in children with asthma. Lung. 1990;168(Suppl):99-102.
    • (1990) Lung , vol.168 , Issue.SUPPL. , pp. 99-102
    • Becker, A.B.1    Simons, F.E.2
  • 37
    • 0032076892 scopus 로고    scopus 로고
    • Effects of treatment with formoterol on bronchoprotection against methacholine
    • Lipworth B, Tan S, Devlin M, Aiken T, Baker R, and Hendrick D: Effects of treatment with formoterol on bronchoprotection against methacholine. Am J Med. 1998;104:431-438.
    • (1998) Am J Med , vol.104 , pp. 431-438
    • Lipworth, B.1    Tan, S.2    Devlin, M.3    Aiken, T.4    Baker, R.5    Hendrick, D.6
  • 40
    • 0034097509 scopus 로고    scopus 로고
    • Demonstration of in vivo bioequivalence of a generic albuterol metered-dose inhaler to Ventolin
    • Stewart BA, Ahrens RC, Carrier S, Frosolono M, Lux C, Han S-H, and Milavetz G: Demonstration of in vivo bioequivalence of a generic albuterol metered-dose inhaler to Ventolin. Chest. 2000;117:714-721.
    • (2000) Chest , vol.117 , pp. 714-721
    • Stewart, B.A.1    Ahrens, R.C.2    Carrier, S.3    Frosolono, M.4    Lux, C.5    Han, S.-H.6    Milavetz, G.7
  • 41
    • 0031667891 scopus 로고    scopus 로고
    • Onset and duration of action of single doses of formoterol inhaled via Turbuhaler
    • Ringdal N, Derom E, Wå hlin-Boll E, and Pauwels R: Onset and duration of action of single doses of formoterol inhaled via Turbuhaler. Respir Med. 1998;92:1017-1021.
    • (1998) Respir Med , vol.92 , pp. 1017-1021
    • Ringdal, N.1    Derom, E.2    Wåhlin-Boll, E.3    Pauwels, R.4
  • 42
    • 0026694561 scopus 로고
    • Formoterol as dry powder inhalation: A dose finding study in comparison with formoterol metered dose inhaler and placebo
    • Maesen FPV, Costongs R, Smeets SJ, Zweers GMA, and Goedhart DM: Formoterol as dry powder inhalation: a dose finding study in comparison with formoterol metered dose inhaler and placebo. Chest. 1992;101:1376-1381.
    • (1992) Chest , vol.101 , pp. 1376-1381
    • Maesen, F.P.V.1    Costongs, R.2    Smeets, S.J.3    Zweers, G.M.A.4    Goedhart, D.M.5
  • 43
    • 0031471788 scopus 로고    scopus 로고
    • Inhaled dry-powder formoterol and salmeterol in asthmatic patients: Onset of action, duration of effect and potency
    • Palmqvist M, Persson G, Lazer L, Rosenborg J, Larsson P, and Lotvall J: Inhaled dry-powder formoterol and salmeterol in asthmatic patients: onset of action, duration of effect and potency. Eur Respir J. 1997;10:2484-2489.
    • (1997) Eur Respir J , vol.10 , pp. 2484-2489
    • Palmqvist, M.1    Persson, G.2    Lazer, L.3    Rosenborg, J.4    Larsson, P.5    Lotvall, J.6
  • 44
    • 20944448388 scopus 로고    scopus 로고
    • A randomized, double-blind, double-dummy, single-dose, efficacy crossover trial comparing formoterol-HFA (pMDI) versus formoterol-DPI (Aerolizer) and placebo (pMDI or Aerolizer) in asthmatic patients
    • Bousquet J, Huchon G, Leclerc V, Vicaut E, and Lefrançois G: A randomized, double-blind, double-dummy, single-dose, efficacy crossover trial comparing formoterol-HFA (pMDI) versus formoterol-DPI (Aerolizer) and placebo (pMDI or Aerolizer) in asthmatic patients. Respiration. 2005; 72(Suppl 1):6-12.
    • (2005) Respiration , vol.72 , Issue.SUPPL. 1 , pp. 6-12
    • Bousquet, J.1    Huchon, G.2    Leclerc, V.3    Vicaut, E.4    Lefrançois, G.5
  • 45
    • 1542298201 scopus 로고    scopus 로고
    • Dose-related efficacy and safety of formoterol (Oxis) Turbuhaler- compared with salmeterol Diskhaler- in children with asthma
    • Pohunek P, Matulka M, Rybnícek O, Kopriva F, Honomichlova ́ H, and Svobodová T : Dose-related efficacy and safety of formoterol (Oxis) Turbuhaler- compared with salmeterol Diskhaler in children with asthma. Pediatr Allergy Immunol. 2004;15:32-39.
    • (2004) Pediatr Allergy Immunol , vol.15 , pp. 32-39
    • Pohunek, P.1    Matulka, M.2    Rybnícek, O.3    Kopriva, F.4    Honomichlová, H.5    Svobodová, T.6
  • 48
    • 0033060321 scopus 로고    scopus 로고
    • Effect of differing doses of inhaled budesonide on markers of airway inflammation in patients with mild asthma
    • Jatakanon A, Kharitonov S, Lim S, and Barnes PJ: Effect of differing doses of inhaled budesonide on markers of airway inflammation in patients with mild asthma. Thorax. 1999; 54:108-114. (Pubitemid 29101352)
    • (1999) Thorax , vol.54 , Issue.2 , pp. 108-114
    • Jatakanon, A.1    Kharitonov, S.2    Lim, S.3    Barnes, P.J.4
  • 49
    • 33646158683 scopus 로고    scopus 로고
    • Eosinophilic bronchitis in asthma: A model for establishing dose-response and relative potency of inhaled corticosteroids
    • Kelly MM, Leigh R, Jayaram L, Goldsmith CH, Parameswaran K, and Hargreave FE: Eosinophilic bronchitis in asthma: a model for establishing dose-response and relative potency of inhaled corticosteroids. J Allergy Clin Immunol. 2006;117:989-994.
    • (2006) J Allergy Clin Immunol , vol.117 , pp. 989-994
    • Kelly, M.M.1    Leigh, R.2    Jayaram, L.3    Goldsmith, C.H.4    Parameswaran, K.5    Hargreave, F.E.6
  • 51
    • 0036795837 scopus 로고    scopus 로고
    • Dose-dependent onset and cessation of action of inhaled budesonide on exhaled nitric oxide and symptoms in mild asthma
    • Kharitonov SA, Donnelly LE, Montuschi P, Corradi M, Collins JV, and Barnes PJ: Dose-dependent onset and cessation of action of inhaled budesonide on exhaled nitric oxide and symptoms in mild asthma. Thorax. 2002;57:889-896.
    • (2002) Thorax , vol.57 , pp. 889-896
    • Kharitonov, S.A.1    Donnelly, L.E.2    Montuschi, P.3    Corradi, M.4    Collins, J.V.5    Barnes, P.J.6
  • 52
    • 57349152279 scopus 로고    scopus 로고
    • The concept of pharmaceutical quality
    • Woodcock J: The concept of pharmaceutical quality. Am Pharm Rev. 2004;7:10-15.
    • (2004) Am Pharm Rev , vol.7 , pp. 10-15
    • Woodcock, J.1
  • 53
    • 70349254921 scopus 로고    scopus 로고
    • DHHS FDA CDER, Center for Biologics Evaluation and Research (CBER): June Available at
    • DHHS, FDA, CDER, Center for Biologics Evaluation and Research (CBER): June 2009. Guidance for Industry: Q8(R1) Pharmaceutical Development. Available at: http://www.fda .gov//downloads//Drugs//GuidanceComplianceRegulatory Information//Guidances//ucm073507.pdf
    • (2009) Guidance for Industry Q8( R1) Pharmaceutical Development
  • 54
    • 43349088601 scopus 로고    scopus 로고
    • Pharmaceutical quality by design: Product and process development, understanding, and control
    • Yu LX: Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res. 2008;25:781-791.
    • (2008) Pharm Res , vol.25 , pp. 781-791
    • Yu, L.X.1
  • 58
    • 76649135417 scopus 로고    scopus 로고
    • Advair Diskus labeling: April, GlaxoSmithKline, Research Triangle Park, NC. Available at
    • Advair Diskus labeling: April 2008, GlaxoSmithKline, Research Triangle Park, NC. Available at: http://www.advair. com//index.html
    • (2008)
  • 59
    • 76649104601 scopus 로고    scopus 로고
    • Chapter : Pharmacopeia 32//National Formulary 27, United States Pharmacopeial Convention, Rockville, MD
    • Chapter : Aerosols, nasal sprays, metered-dose inhalers, and dry powder inhalers U.S. Pharmacopeia 32//National Formulary 27, United States Pharmacopeial Convention, Rockville, MD, 2009.
    • (2009) Aerosols, Nasal Sprays, Metered-dose Inhalers, and Dry Powder Inhalers U.S
  • 60
    • 76649114592 scopus 로고    scopus 로고
    • Effect of rate of rise in simulated inspiratory air flow on dry powder inhaler (DPI) performance
    • RN Dalby, PR Byron, SJ Farr, and J Peart (eds). Serentec Press, Raleigh, NC
    • Chavan V, and Dalby R: Effect of rate of rise in simulated inspiratory air flow on dry powder inhaler (DPI) performance. In: RN Dalby, PR Byron, SJ Farr, and J Peart (eds). Respiratory Drug Delivery VII, Vol II. Serentec Press, Raleigh, NC; pp. 593-596, 2000.
    • (2000) Respiratory Drug Delivery VII , vol.2 , pp. 593-596
    • Chavan, V.1    Dalby, R.2
  • 61
    • 29844458705 scopus 로고    scopus 로고
    • Effect of inherent variability of inhalation products on impactor mass balance limits
    • Bagger-Jorgensen H, Sandell D, Lundback H, and Sundahl M: Effect of inherent variability of inhalation products on impactor mass balance limits. J Aerosol Med. 2005;18:367-378.
    • (2005) J Aerosol Med , vol.18 , pp. 367-378
    • Bagger-Jorgensen, H.1    Sandell, D.2    Lundback, H.3    Sundahl, M.4
  • 62
    • 76649138859 scopus 로고    scopus 로고
    • The discriminatory nature of the spray pattern test
    • Abstract 668
    • O'Connor D, Tougas T, Patel R, Davidson W, and Carr D: The discriminatory nature of the spray pattern test. AAPS J 2005;7(Suppl 2):Abstract 668.
    • (2005) AAPS J , vol.7 , Issue.SUPPL. 2
    • O'Connor, D.1    Tougas, T.2    Patel, R.3    Davidson, W.4    Carr, D.5
  • 64
    • 68249098193 scopus 로고    scopus 로고
    • Evaluation of impaction force of nasal sprays and metered-dose inhalers using the texture analyser
    • Guo C, Ye W, Kauffman J, and Doub WH: Evaluation of impaction force of nasal sprays and metered-dose inhalers using the texture analyser. J Pharm Sci. 2008;98:2799-2806.
    • (2008) J Pharm Sci , vol.98 , pp. 2799-2806
    • Guo, C.1    Ye, W.2    Kauffman, J.3    Doub, W.H.4
  • 65
    • 76649144418 scopus 로고    scopus 로고
    • CDER: Approved drug products with therapeutic equivalence evaluations (''Orange Book'')
    • DHHS FDA 29th ed, Available at
    • DHHS, FDA, CDER: Approved Drug Products with Therapeutic Equivalence Evaluations (''Orange Book''), 29th ed, 2009, Therapeutic equivalence-related terms, pp. vi-viii. Available at: http://www.fda.gov//downloads//Drugs// DevelopmentApprovalProcess//UCM071436.pdf
    • (2009) Therapeutic Equivalence-related Terms , pp. 6-8
  • 66
    • 0035100888 scopus 로고    scopus 로고
    • Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
    • Biomarkers Definitions Working Group
    • Biomarkers Definitions Working Group: Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69:89-95.
    • (2001) Clin Pharmacol Ther , vol.69 , pp. 89-95
  • 67
    • 76649126666 scopus 로고
    • Guidance: Topical dermatologic corticosteroids
    • DHHS FDA CDER: 2 June Available at
    • DHHS, FDA, CDER: 2 June 1995, Guidance: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence. Available at: http://www.fda.gov// downloads//Drugs//Guidance ComplianceRegulatoryInformation//Guidances// ucm070234. pdf
    • (1995) Vivo Bioequivalence
  • 69
    • 0032908306 scopus 로고    scopus 로고
    • Clinical comparability of albuterol delivered by the breath-actuated inhaler (Spiros) and albuterol by MDI in patients with asthma
    • Geoffroy P, Lalonde RL, Ahrens R, Clarke W, Hill MR, Vaughan LM, and Grossman J: Clinical comparability of albuterol delivered by the breath-actuated inhaler (Spiros) and albuterol by MDI in patients with asthma. Ann Allergy Asthma Immunol. 1999;82:377-382.
    • (1999) Ann Allergy Asthma Immunol , vol.82 , pp. 377-382
    • Geoffroy, P.1    Lalonde, R.L.2    Ahrens, R.3    Clarke, W.4    Hill, M.R.5    Vaughan, L.M.6    Grossman, J.7
  • 70
    • 0026525373 scopus 로고
    • The effect of inhaled salmeterol on methacholine responsiveness in subjects with asthma up to 12 hours
    • Derom EY, Pauwels RA, and Van Der Straeten MEF: the effect of inhaled salmeterol on methacholine responsiveness in subjects with asthma up to 12 hours. J Allergy Clin Immunol. 1992;89:811-815.
    • (1992) J Allergy Clin Immunol , vol.89 , pp. 811-815
    • Derom, E.Y.1    Pauwels, R.A.2    Van Der Straeten, M.E.F.3
  • 72
    • 76649135416 scopus 로고    scopus 로고
    • Stability of asthma following maximization of lung function with a high-dose inhaled corticosteroid (ICS) burst: A more precise method for comparing clinical potency of ICS
    • Ahrens RC, Hendeles L, Teresi ME, Lux CR, Vanden Burgt J, Hart KA, and Ekholm BP: Stability of asthma following maximization of lung function with a high-dose inhaled corticosteroid (ICS) burst: a more precise method for comparing clinical potency of ICS. J Aerosol Med. 2003; 16:197.
    • (2003) J Aerosol Med , vol.16 , pp. 197
    • Ahrens, R.C.1    Hendeles, L.2    Teresi, M.E.3    Lux, C.R.4    Vanden Burgt, J.5    Hart, K.A.6    Ekholm, B.P.7
  • 73
    • 62149143878 scopus 로고    scopus 로고
    • Therapeutic equivalence of inhaled corticosteroids-workshop on regional differences in regulatory requirements
    • RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Book 1. Davis Healthcare, River Grove, IL
    • Fuglsang A, Leach C, and Mayers I: Therapeutic equivalence of inhaled corticosteroids-workshop on regional differences in regulatory requirements. In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Respiratory Drug Delivery 2008, Book 1. Davis Healthcare, River Grove, IL; pp. 133-147, 2008.
    • (2008) Respiratory Drug Delivery 2008 , pp. 133-147
    • Fuglsang, A.1    Leach, C.2    Mayers, I.3
  • 74
    • 20544455549 scopus 로고    scopus 로고
    • Dose-response comparison of budesonide dry powder inhalers using adenosine monophosphate bronchial challenge
    • Lipworth BJ, Sims EJ, Das SK, Buck H, and Paterson M: Dose-response comparison of budesonide dry powder inhalers using adenosine monophosphate bronchial challenge. Ann Allergy Asthma Immunol. 2005;94:675-681.
    • (2005) Ann Allergy Asthma Immunol , vol.94 , pp. 675-681
    • Lipworth, B.J.1    Sims, E.J.2    Das, S.K.3    Buck, H.4    Paterson, M.5
  • 75
    • 62149151508 scopus 로고    scopus 로고
    • Proving inhaled corticosteroid equivalence: What are the clinically acceptable differences in performance?
    • RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Book 1. Davis Healthcare, River Grove, IL
    • Ahrens RC: Proving inhaled corticosteroid equivalence: what are the clinically acceptable differences in performance? In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Respiratory Drug Delivery 2008, Book 1. Davis Healthcare, River Grove, IL, 2008, pp. 101-108.
    • (2008) Respiratory Drug Delivery 2008 , pp. 101-108
    • Ahrens, R.C.1
  • 76
    • 76649087247 scopus 로고    scopus 로고
    • Gamma scintigraphy and SPECT
    • G Lappin G, and S Temple, (eds). CRC Press, Boca Raton, FL: chap 12
    • Newman SP, and Pitcairn GR: Gamma scintigraphy and SPECT. In: G Lappin G, and S Temple, (eds). Radiotracers in Drug Development. CRC Press, Boca Raton, FL; chap 12, 2006.
    • (2006) Radiotracers in Drug Development
    • Newman, S.P.1    Pitcairn, G.R.2
  • 77
    • 0038771107 scopus 로고    scopus 로고
    • Radionuclide imaging technologies and their use in evaluating asthma drug deposition in the lungs
    • Newman SP, Pitcairn GR, Hirst PH, and Rankin L: Radionuclide imaging technologies and their use in evaluating asthma drug deposition in the lungs. Adv Drug Deliv Rev. 2003;55:851-867.
    • (2003) Adv Drug Deliv Rev , vol.55 , pp. 851-867
    • Newman, S.P.1    Pitcairn, G.R.2    Hirst, P.H.3    Rankin, L.4
  • 78
    • 0002876090 scopus 로고    scopus 로고
    • Understanding regional lung deposition data in gamma scintigrapy
    • RN Dalby, PR Byron, and SJ Farr SJ, (eds) Interpharm Press, Buffalo Grove, IL
    • Newman SP, Hirst PH, Pitcairn GR, and Clark AR: Understanding regional lung deposition data in gamma scintigrapy. In: RN Dalby, PR Byron, and SJ Farr SJ, (eds). Respiratory Drug Delivery VI. Interpharm Press, Buffalo Grove, IL; pp. 9-15, 1998.
    • (1998) Respiratory Drug Delivery VI , pp. 9-15
    • Newman, S.P.1    Hirst, P.H.2    Pitcairn, G.R.3    Clark, A.R.4
  • 79
    • 0002611867 scopus 로고    scopus 로고
    • Radiolabelling of dry powder formulations
    • RN Dalby, PR Byron, and SJ Farr, (eds) Interpharm Press, Buffalo Grove, IL
    • Pitcairn GR, and Newman SP: Radiolabelling of dry powder formulations. In: RN Dalby, PR Byron, and SJ Farr, (eds). Respiratory Drug Delivery VI. Interpharm Press, Buffalo Grove, IL; pp. 397-399, 1998.
    • (1998) Respiratory Drug Delivery VI , pp. 397-399
    • Pitcairn, G.R.1    Newman, S.P.2
  • 80
    • 0033072264 scopus 로고    scopus 로고
    • Assessing lung deposition of inhaled medications
    • Snell NJC, and Ganderton D: Assessing lung deposition of inhaled medications. Respir Med. 1999;93:123-133.
    • (1999) Respir Med , vol.93 , pp. 123-133
    • Snell, N.J.C.1    Ganderton, D.2
  • 81
    • 34247516499 scopus 로고    scopus 로고
    • US regulatory and scientific considerations for approval of generic locally acting orally inhaled and nasal drug products
    • RN Dalby, PR Byron, J Peart, and JD Suman, (eds). Davis Healthcare, River Grove, IL
    • Singh GJP, and Adams WP: US regulatory and scientific considerations for approval of generic locally acting orally inhaled and nasal drug products. In: RN Dalby, PR Byron, J Peart, and JD Suman, (eds). Respiratory Drug Delivery Europe 2005. Davis Healthcare, River Grove, IL; pp. 115-125, 2005.
    • (2005) Respiratory Drug Delivery Europe 2005 , pp. 115-125
    • Singh, G.J.P.1    Adams, W.P.2
  • 82
    • 76649107607 scopus 로고    scopus 로고
    • The regulatory demands of clinical testing protocols for powder inhalers in the USA
    • RN Dalby, PR Byron, J Peart, and JD Suman (eds). Davis Healthcare, River Grove, IL
    • Chowdhury BA: The regulatory demands of clinical testing protocols for powder inhalers in the USA. In: RN Dalby, PR Byron, J Peart, and JD Suman (eds). Respiratory Drug Delivery Europe 2007. Davis Healthcare, River Grove, IL; pp. 101-107, 2007.
    • (2007) Respiratory Drug Delivery Europe 2007 , pp. 101-107
    • Chowdhury, B.A.1
  • 83
    • 76649136396 scopus 로고    scopus 로고
    • Bioequivalence of inhaled corticosteroids-with emphasis on pharmacokinetic tools
    • Bethesda, MD, March 9-10, Available at
    • Hochhaus G: Bioequivalence of inhaled corticosteroids-with emphasis on pharmacokinetic tools. In: PQRI Workshop on Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products. Bethesda, MD, March 9-10, 2009. Available at: http://www.pqri.org//workshops//Bioequiv//imagespdfs//final// Hochhaus-final.pdf
    • (2009) PQRI Workshop on Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products
    • Hochhaus, G.1
  • 84
    • 0024993410 scopus 로고
    • A method for determination of the absolute pulmonary availability of inhaled drugs: Terbutaline
    • Borgström L, and Nilsson M: A method for determination of the absolute pulmonary availability of inhaled drugs: Terbutaline. Pharm. Res. 1990;7:1068-1070.
    • (1990) Pharm. Res , vol.7 , pp. 1068-1070
    • Borgström, L.1    Nilsson, M.2
  • 85
    • 0027986957 scopus 로고
    • Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered-dose inhaler P-MDI
    • Thorsson L, Edsbäcker S, and Conradson T-B: Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered-dose inhaler P-MDI. Eur Respir J. 1994; 7:1839-1844.
    • (1994) Eur Respir J , vol.7 , pp. 1839-1844
    • Thorsson, L.1    Edsbäcker, S.2    Conradson, T.-B.3
  • 86
    • 0032422332 scopus 로고    scopus 로고
    • Lung deposition of budesonide from a pressurized metered-dose inhaler attached to a spacer
    • Thorsson L, and Edsbacker S: Lung deposition of budesonide from a pressurized metered-dose inhaler attached to a spacer. Eur Respir J.1998;12:1340-1345.
    • (1998) Eur Respir J , vol.12 , pp. 1340-1345
    • Thorsson, L.1    Edsbacker, S.2
  • 87
    • 0033018882 scopus 로고    scopus 로고
    • The contribution of the swallowed fraction of an inhaled dose of salmeterol to its systemic effects
    • Bennett JA, Harrison TW, and Tattersfield AE: The contribution of the swallowed fraction of an inhaled dose of salmeterol to its systemic effects. Eur Respir J. 1999;13: 445-448.
    • (1999) Eur Respir J , vol.13 , pp. 445-448
    • Bennett, J.A.1    Harrison, T.W.2    Tattersfield, A.E.3
  • 88
    • 0033956072 scopus 로고    scopus 로고
    • Enantiomeric disposition of inhaled, intravenous and oral racemic-salbutamol in man-no evidence of enantioselective lung metabolism
    • Ward JK, Dow J, Dallow N, Eynott P, Milleri S, and Ventresca GP. Enantiomeric disposition of inhaled, intravenous and oral racemic-salbutamol in man-no evidence of enantioselective lung metabolism. Br J Clin Pharmacol 2000; 49:15-22.
    • (2000) Br J Clin Pharmacol , vol.49 , pp. 15-22
    • Ward, J.K.1    Dow, J.2    Dallow, N.3    Eynott, P.4    Milleri, S.5    Ventresca, G.P.6
  • 89
    • 0036042158 scopus 로고    scopus 로고
    • Determination of the relative bioavailability of salbutamol to the lungs and systemic circulation following nebulization
    • Silkstone VL, Corlett SA, and Chrystyn H: Determination of the relative bioavailability of salbutamol to the lungs and systemic circulation following nebulization. Br J Clin Pharmacol. 2002;54:115-119.
    • (2002) Br J Clin Pharmacol , vol.54 , pp. 115-119
    • Silkstone, V.L.1    Corlett, S.A.2    Chrystyn, H.3
  • 90
    • 76649144417 scopus 로고    scopus 로고
    • Joint Meeting of the Advisory Committee for Pharmaceutical Science and the Pulmonary-Allergy Drugs Advisory Committee. FDA, Gaithersburg, MD. 16 August, Transcript
    • Singh G. Agenda Item: Bioequivalence of Albuterol MDIs. Joint Meeting of the Advisory Committee for Pharmaceutical Science and the Pulmonary-Allergy Drugs Advisory Committee. FDA, Gaithersburg, MD. 16 August 1996, Transcript, pp. 53-68.
    • (1996) Agenda Item: Bioequivalence of Albuterol MDIs , pp. 53-68
    • Singh, G.1
  • 91
    • 76649114288 scopus 로고    scopus 로고
    • The FDA critical path initiative: Clinical considerations for demonstration of dose-response for inhaled corticosteroids-exhaled nitric oxide model
    • Bethesda, MD, March 9-10, Available at
    • Chowdhury BA: The FDA critical path initiative: clinical considerations for demonstration of dose-response for inhaled corticosteroids-exhaled nitric oxide model. In: PQRI Workshop on Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products, Bethesda, MD, March 9-10, 2009. Available at: http://www.pqri.org//workshops//Bioequiv//imagespdfs//final// Chowdhury-9Mar09-PQRI.pdf
    • (2009) PQRI Workshop on Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products
    • Chowdhury, B.A.1
  • 92
    • 17644363081 scopus 로고    scopus 로고
    • ATS//ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxid 2005
    • Joint Statement of the American Thoracic Society and the European Respiratory Society
    • Joint Statement of the American Thoracic Society and the European Respiratory Society: ATS//ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide. 2005. Am J Respir Crit Care Med. 2005;171: 912-930.
    • (2005) Am J Respir Crit Care Med , vol.171 , pp. 912-930
  • 93
    • 7944232729 scopus 로고    scopus 로고
    • The aerocrine exhaled nitric oxide monitoring system NIOX is cleared by the US Food and Drug Administration for monitoring therapy in asthma
    • Silkoff PE, Carlson M, Bourke T, Katial R, Ogren E, and Szefler SJ: The aerocrine exhaled nitric oxide monitoring system NIOX is cleared by the US Food and Drug Administration for monitoring therapy in asthma. J Allergy Clin Immunol. 2004;114:1241-1256.
    • (2004) J Allergy Clin Immunol , vol.114 , pp. 1241-1256
    • Silkoff, P.E.1    Carlson, M.2    Bourke, T.3    Katial, R.4    Ogren, E.5    Szefler, S.J.6
  • 94
    • 1942468906 scopus 로고    scopus 로고
    • In-vitro intra- and inter-inhaler flow rate-dependent dosage emission from a combination of budesonide and eformoterol in a dry powder inhaler
    • Tarsin W, Assi KH, and Chrystyn H: In-vitro intra- and inter-inhaler flow rate-dependent dosage emission from a combination of budesonide and eformoterol in a dry powder inhaler. J Aerosol Med. 2004;17:25-32.
    • (2004) J Aerosol Med , vol.17 , pp. 25-32
    • Tarsin, W.1    Assi, K.H.2    Chrystyn, H.3
  • 95
    • 0024205531 scopus 로고
    • Inhalation rate of sodium cromoglycate determines plasma pharmacokinetics and protection against AMP-induced bronchoconstriction in asthma
    • Richards R, Simpson SF, Renwick AG, and Holgate ST: Inhalation rate of sodium cromoglycate determines plasma pharmacokinetics and protection against AMP-induced bronchoconstriction in asthma. Eur Respir J. 1988;1:896-901.
    • (1988) Eur Respir J , vol.1 , pp. 896-901
    • Richards, R.1    Simpson, S.F.2    Renwick, A.G.3    Holgate, S.T.4
  • 96
    • 0025275637 scopus 로고
    • Influence of inspiratory flow rate upon the effect of a Turbuhaler
    • Pedersen S, Hansen OR, and Fuglsang G: Influence of inspiratory flow rate upon the effect of a Turbuhaler. Arch Dis Child. 1990;65:308-310.
    • (1990) Arch Dis Child , vol.65 , pp. 308-310
    • Pedersen, S.1    Hansen, O.R.2    Fuglsang, G.3
  • 97
    • 0026579116 scopus 로고
    • Effects, side effects and plasma concentrations of turbutaline in adult asthmatics after inhaling from a dry powder inhaler device at different inhalation flows and volumes
    • Engel T, Scharling B, Skovsted B, and Heinig JH: Effects, side effects and plasma concentrations of turbutaline in adult asthmatics after inhaling from a dry powder inhaler device at different inhalation flows and volumes. Br J Clin Pharmacol. 1992;33:439-444.
    • (1992) Br J Clin Pharmacol , vol.33 , pp. 439-444
    • Engel, T.1    Scharling, B.2    Skovsted, B.3    Heinig, J.H.4


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