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Volumn 17, Issue 3, 2015, Pages 758-768

Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products

Author keywords

inhaled bronchodilators; inhaled corticosteroids; methacholine; pharmacodynamics

Indexed keywords

BRONCHODILATING AGENT; GLUCOCORTICOID;

EID: 84939564601     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9735-7     Document Type: Article
Times cited : (9)

References (37)
  • 1
    • 84962673331 scopus 로고    scopus 로고
    • Biomarkers of the anti-inflammatory effects in the airways and the evaluation of therapeutic equivalence
    • Daley-Yates P. Biomarkers of the anti-inflammatory effects in the airways and the evaluation of therapeutic equivalence. IPAC-RS/UF Inhalation Conference in Orlando. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 13 Nov 2014.
    • (2014) IPAC-RS/UF Inhalation Conference in Orlando
    • Daley-Yates, P.1
  • 2
    • 80052438246 scopus 로고    scopus 로고
    • An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications
    • COI: 1:CAS:528:DC%2BC3MXhtlWqtrfM, PID: 21885636
    • Dweik RA, Boggs PB, Erzurum SC, Irvin CG, Leigh MW, Lundberg JO, et al. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011;184:602–15.
    • (2011) Am J Respir Crit Care Med , vol.184 , pp. 602-615
    • Dweik, R.A.1    Boggs, P.B.2    Erzurum, S.C.3    Irvin, C.G.4    Leigh, M.W.5    Lundberg, J.O.6
  • 3
    • 84962743071 scopus 로고    scopus 로고
    • Exhaled nitric oxide (eNO) versus adenosine-5′-monophosphate (AMP) challenge for demonstrating dose response to inhaled corticosteroid (abstract)
    • Daley-Yates PT, Austin DJ, Bentley JH. Exhaled nitric oxide (eNO) versus adenosine-5′-monophosphate (AMP) challenge for demonstrating dose response to inhaled corticosteroid (abstract). Am J Respir Crit Care Med. 2013;187:A1926.
    • (2013) Am J Respir Crit Care Med , vol.187 , pp. A1926
    • Daley-Yates, P.T.1    Austin, D.J.2    Bentley, J.H.3
  • 4
    • 47249121722 scopus 로고    scopus 로고
    • The reproducibility of adenosine monophosphate bronchial challenges in mind, steroid-naive asthmatics
    • COI: 1:CAS:528:DC%2BD1cXhtVegs7vM, PID: 18507658
    • Singh D, Fairwood J, Murdoch R, Weeks A, Russell P, Roy K, et al. The reproducibility of adenosine monophosphate bronchial challenges in mind, steroid-naive asthmatics. Br J Clin Pharmacol. 2008;66:261–5.
    • (2008) Br J Clin Pharmacol , vol.66 , pp. 261-265
    • Singh, D.1    Fairwood, J.2    Murdoch, R.3    Weeks, A.4    Russell, P.5    Roy, K.6
  • 5
    • 84962744700 scopus 로고    scopus 로고
    • Evaluation of exhaled nitric oxide (eNO) as a tool for bioequivalence testing of inhaled corticosteroids (abstract)
    • Austin DJ, Daley-Yates PT. Evaluation of exhaled nitric oxide (eNO) as a tool for bioequivalence testing of inhaled corticosteroids (abstract). Am J Respir Crit Care Med. 2013;187:A1927.
    • (2013) Am J Respir Crit Care Med , vol.187 , pp. A1927
    • Austin, D.J.1    Daley-Yates, P.T.2
  • 6
    • 84962740923 scopus 로고    scopus 로고
    • Evaluation of the feasibility of pharmacodynamic BE studies of OIDPs through Monte Carlo simulations
    • Kandala B. Evaluation of the feasibility of pharmacodynamic BE studies of OIDPs through Monte Carlo simulations. IPAC-RS/UF Inhalation Conference in Orlando. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 13 Nov 2014.
    • (2014) IPAC-RS/UF Inhalation Conference in Orlando
    • Kandala, B.1
  • 7
    • 84962665474 scopus 로고    scopus 로고
    • Weiler JM, Sorkness CA, Hendeles L, Zhu Y, Nichols S. Exploration of exhaled nitric oxide (eNO) levels following treatment with fluticasone propionate (FP)/salmeterol xinafoate (SX) combination inhaled product to demonstrate pharmacodynamic (PD) FP bioequivalence (BE). ClinicalTrials.gov NCT 00927758. Accessed 25 Nov 2014
    • Weiler JM, Sorkness CA, Hendeles L, Zhu Y, Nichols S. Exploration of exhaled nitric oxide (eNO) levels following treatment with fluticasone propionate (FP)/salmeterol xinafoate (SX) combination inhaled product to demonstrate pharmacodynamic (PD) FP bioequivalence (BE). ClinicalTrials.gov NCT 00927758. Accessed 25 Nov 2014.
  • 8
    • 84962694969 scopus 로고    scopus 로고
    • Points to consider in the design and conduct of HPA-axis studies comparing the systemic safety of ICS-products
    • Hermann R. Points to consider in the design and conduct of HPA-axis studies comparing the systemic safety of ICS-products. IPAC-RS/UF Inhalation Conference in Orlando. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 13 Nov 2014.
    • (2014) IPAC-RS/UF Inhalation Conference in Orlando
    • Hermann, R.1
  • 9
    • 84962695049 scopus 로고    scopus 로고
    • Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents
    • European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents. CPMP/EWP/4151/00 Rev. 1; 22 January 2009. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003504.pdf. Accessed 22 Oct 2014.
    • (2009) CPMP/EWP/4151/00 Rev , vol.1 , pp. 22
  • 10
    • 84940000120 scopus 로고    scopus 로고
    • Food and Drug Administration. Draft guidance on fluticasone propionate; salmeterol xinafoate. Recommended September 2013. Accessed 21 Oct 2014
    • Food and Drug Administration. Draft guidance on fluticasone propionate; salmeterol xinafoate. Recommended September 2013. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm367643.pdf. Accessed 21 Oct 2014.
  • 11
    • 84940002985 scopus 로고    scopus 로고
    • Hillerød, Denmark:
    • WHO-Five Well-being Index (WHO-5). Psychiatric Research Unit, Mental Health Central North Zealand, Hillerød, Denmark. 2014. http://www.who-5.org. Accessed 21 Oct 2014.
    • (2014) Mental Health Central North Zealand
  • 12
    • 0031737777 scopus 로고    scopus 로고
    • Interperson variability but intraperson stability of baseline plasma cortisol concentrations, and its relation to feedback sensitivity of the hypothalamo-pituitary-adrenal axis to a low dose of dexamethasone in elderly individuals
    • COI: 1:CAS:528:DyaK1cXitVCqsA%3D%3D, PID: 9435415
    • Huizenga NA, Koper JW, de Lange P, Pols HA, Stolk RP, Grobbee DE, et al. Interperson variability but intraperson stability of baseline plasma cortisol concentrations, and its relation to feedback sensitivity of the hypothalamo-pituitary-adrenal axis to a low dose of dexamethasone in elderly individuals. J Clin Endocrinol Metab. 1998;83:47–54.
    • (1998) J Clin Endocrinol Metab , vol.83 , pp. 47-54
    • Huizenga, N.A.1    Koper, J.W.2    de Lange, P.3    Pols, H.A.4    Stolk, R.P.5    Grobbee, D.E.6
  • 13
    • 33845235453 scopus 로고    scopus 로고
    • Glucocorticoid resistance syndrome: a diagnostic and therapeutic approach
    • PID: 17161335
    • van Rossum EF, Lamberts SW. Glucocorticoid resistance syndrome: a diagnostic and therapeutic approach. Best Pract Res Clin Endocrinol Metab. 2006;20:611–26.
    • (2006) Best Pract Res Clin Endocrinol Metab , vol.20 , pp. 611-626
    • van Rossum, E.F.1    Lamberts, S.W.2
  • 14
    • 0142188580 scopus 로고    scopus 로고
    • Reproducibility of the circadian rhythms of serum cortisol and melatonin in healthy subjects: a study of three different 24-h cycles over six weeks
    • COI: 1:CAS:528:DC%2BD3sXot12jurk%3D, PID: 14572876
    • Selmaoui B, Touitou Y. Reproducibility of the circadian rhythms of serum cortisol and melatonin in healthy subjects: a study of three different 24-h cycles over six weeks. Life Sci. 2003;73:3339–49.
    • (2003) Life Sci , vol.73 , pp. 3339-3349
    • Selmaoui, B.1    Touitou, Y.2
  • 15
    • 84962745615 scopus 로고    scopus 로고
    • Use of bronchoprovocation to determine bioequivalence of beta agonists
    • Hendeles L. Use of bronchoprovocation to determine bioequivalence of beta agonists. IPAC-RS/UF Inhalation Conference in Orlando. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 13 Nov 2014.
    • (2014) IPAC-RS/UF Inhalation Conference in Orlando
    • Hendeles, L.1
  • 16
    • 0023258248 scopus 로고
    • Use of bronchial provocation with histamine to compare the pharmacodynamics of inhaled albuterol and metaproterenol in patients with asthma
    • COI: 1:STN:280:DyaL2s3itlKisg%3D%3D, PID: 3294976
    • Ahrens RC, Harris JB, Milavetz G, Annis L, Ries R. Use of bronchial provocation with histamine to compare the pharmacodynamics of inhaled albuterol and metaproterenol in patients with asthma. J Allergy Clin Immunol. 1987;79:876–82.
    • (1987) J Allergy Clin Immunol , vol.79 , pp. 876-882
    • Ahrens, R.C.1    Harris, J.B.2    Milavetz, G.3    Annis, L.4    Ries, R.5
  • 17
    • 0032828213 scopus 로고    scopus 로고
    • Therapeutic equivalence of Spiros dry powder inhaler and Ventolin metered dose inhaler. A bioassay using methacholine
    • COI: 1:STN:280:DyaK1MvjvFygug%3D%3D, PID: 10508813
    • Ahrens RC, Hendeles L, Clarke WR, Dockhorn RJ, Hill MR, Vaughan LM, et al. Therapeutic equivalence of Spiros dry powder inhaler and Ventolin metered dose inhaler. A bioassay using methacholine. Am J Respir Crit Care Med. 1999;160:1238–43.
    • (1999) Am J Respir Crit Care Med , vol.160 , pp. 1238-1243
    • Ahrens, R.C.1    Hendeles, L.2    Clarke, W.R.3    Dockhorn, R.J.4    Hill, M.R.5    Vaughan, L.M.6
  • 18
    • 0032766402 scopus 로고    scopus 로고
    • Protection against methacholine bronchoconstriction to assess relative potency of inhaled beta2-agonist
    • COI: 1:STN:280:DyaK1Mzit1aqtA%3D%3D, PID: 10390425
    • Parameswaran KN, Inman MD, Ekholm BP, Morris MM, Summers E, O’Byrne PM, et al. Protection against methacholine bronchoconstriction to assess relative potency of inhaled beta2-agonist. Am J Respir Crit Care Med. 1999;160:354–7.
    • (1999) Am J Respir Crit Care Med , vol.160 , pp. 354-357
    • Parameswaran, K.N.1    Inman, M.D.2    Ekholm, B.P.3    Morris, M.M.4    Summers, E.5    O’Byrne, P.M.6
  • 20
    • 84962717757 scopus 로고    scopus 로고
    • Hendeles L, Ahrens R, Sorkness C, Nguyen DT, Maus J, Dakovic R. Relative potency of formoterol Novolizer® 12 μg compared to formoterol Aerolizer® 12 μg in patients with stable asthma using bronchoprovocation with methacholine as a bioassay. Clinicaltrials.gov identifier: NCT01256086. Accessed 17 Jul 2014
    • Hendeles L, Ahrens R, Sorkness C, Nguyen DT, Maus J, Dakovic R. Relative potency of formoterol Novolizer® 12 μg compared to formoterol Aerolizer® 12 μg in patients with stable asthma using bronchoprovocation with methacholine as a bioassay. Clinicaltrials.gov identifier: NCT01256086. Accessed 17 Jul 2014.
  • 21
    • 84962678676 scopus 로고    scopus 로고
    • Handling reference product variability in PK/PD trials
    • Darken P. Handling reference product variability in PK/PD trials. IPAC-RS/UF Inhalation Conference in Orlando. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 13 Nov 2014.
    • (2014) IPAC-RS/UF Inhalation Conference in Orlando
    • Darken, P.1
  • 22
    • 84962779703 scopus 로고    scopus 로고
    • Some statistical considerations in the design and analysis of equivalence studies using pharmacodynamic and clinical endpoints
    • Haughie S. Some statistical considerations in the design and analysis of equivalence studies using pharmacodynamic and clinical endpoints. IPAC-RS/UF Inhalation Conference in Orlando. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 13 Nov 2014.
    • (2014) IPAC-RS/UF Inhalation Conference in Orlando
    • Haughie, S.1
  • 23
    • 0032793507 scopus 로고    scopus 로고
    • Comparison of the relative efficacy of formoterol and salmeterol in asthmatic patients
    • COI: 1:STN:280:DyaK1Mzit1akug%3D%3D, PID: 10390407
    • Palmqvist M, Ibsen T, Mellén A, Lötvall J. Comparison of the relative efficacy of formoterol and salmeterol in asthmatic patients. Am J Respir Crit Care Med. 1999;160:244–9.
    • (1999) Am J Respir Crit Care Med , vol.160 , pp. 244-249
    • Palmqvist, M.1    Ibsen, T.2    Mellén, A.3    Lötvall, J.4
  • 24
    • 0026525373 scopus 로고
    • The effect of inhaled salmeterol on methacholine responsiveness in subjects with asthma up to 12 hours
    • COI: 1:STN:280:DyaK383hvVOnuw%3D%3D, PID: 1560164
    • Derom EY, Pauwels RA, Van der Straeten ME. The effect of inhaled salmeterol on methacholine responsiveness in subjects with asthma up to 12 hours. J Allergy Clin Immunol. 1992;89:811–5.
    • (1992) J Allergy Clin Immunol , vol.89 , pp. 811-815
    • Derom, E.Y.1    Pauwels, R.A.2    Van der Straeten, M.E.3
  • 25
    • 0030831740 scopus 로고    scopus 로고
    • Dose equivalence and bronchoprotective effects of salmeterol and salbutamol in asthma
    • COI: 1:STN:280:DyaK1c7kvVehtA%3D%3D, PID: 9487346
    • Higham MA, Sharara AM, Wilson P, Jenkins RJ, Glendenning GA, Ind PW. Dose equivalence and bronchoprotective effects of salmeterol and salbutamol in asthma. Thorax. 1997;52:975–80.
    • (1997) Thorax , vol.52 , pp. 975-980
    • Higham, M.A.1    Sharara, A.M.2    Wilson, P.3    Jenkins, R.J.4    Glendenning, G.A.5    Ind, P.W.6
  • 26
    • 84962717433 scopus 로고    scopus 로고
    • Recommended April 2013
    • Food and Drug Administration. Draft Guidance on Albuterol Sulfate. Recommended April 2013, Revised June 2013. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm346985.pdf. Accessed 22 Oct 2014.
    • (2013) Revised
  • 27
    • 84962680399 scopus 로고    scopus 로고
    • Case Study: PK and PD tiotropium in COPD HandiHaler 2
    • Horhota S. IVIV OIP BE Case Study: PK and PD tiotropium in COPD HandiHaler 2. IPAC-RS/UF Inhalation Conference in Orlando. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 13 Nov 2014.
    • (2014) IPAC-RS/UF Inhalation Conference in Orlando
    • Horhota, S.I.V.I.V.O.I.P.B.E.1
  • 28
    • 84962722051 scopus 로고    scopus 로고
    • 2-agonist metered dose inhaler. 1999. Accessed 24 Oct 2014
    • 2-agonist metered dose inhaler. 1999. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/inhal-aerosol/mdi_bad-eng.php. Accessed 24 Oct 2014.
  • 29
    • 0030925304 scopus 로고    scopus 로고
    • Time course and relative dose potency of systemic effects from salmeterol and salbutamol in healthy subjects
    • COI: 1:STN:280:DyaK2szhvFKgtA%3D%3D, PID: 9176539
    • Bennett JA, Tattersfield AE. Time course and relative dose potency of systemic effects from salmeterol and salbutamol in healthy subjects. Thorax. 1997;52:458–64.
    • (1997) Thorax , vol.52 , pp. 458-464
    • Bennett, J.A.1    Tattersfield, A.E.2
  • 30
    • 0033940928 scopus 로고    scopus 로고
    • Systemic effects of formoterol and salmeterol: a dose–response comparison in healthy subjects
    • COI: 1:STN:280:DC%2BD3czpvFWgtQ%3D%3D, PID: 10899240
    • Guhan AR, Cooper S, Oborne J, Lewis S, Bennett J, Tattersfield AE. Systemic effects of formoterol and salmeterol: a dose–response comparison in healthy subjects. Thorax. 2000;55:650–6.
    • (2000) Thorax , vol.55 , pp. 650-656
    • Guhan, A.R.1    Cooper, S.2    Oborne, J.3    Lewis, S.4    Bennett, J.5    Tattersfield, A.E.6
  • 31
    • 14844349948 scopus 로고    scopus 로고
    • Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects
    • PID: 15777604
    • Kempsford R, Handel M, Mehta R, De Silva M, Daley-Yates P. Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects. Respir Med. 2005;99 Suppl 1:S11–19.
    • (2005) Respir Med , vol.99 , pp. S11-S19
    • Kempsford, R.1    Handel, M.2    Mehta, R.3    De Silva, M.4    Daley-Yates, P.5
  • 32
    • 77952052809 scopus 로고    scopus 로고
    • Systemic bioavailability of hydrofluoroalkane (HFA) formulations of fluticasone/salmeterol in health volunteers via pMDI alone and spacer
    • COI: 1:CAS:528:DC%2BC3cXot1Kis7o%3D, PID: 20565455
    • Clearie KL, Williamson PA, Vaidyanathan S, Du Bois J, Nell H, Lipworth BJ. Systemic bioavailability of hydrofluoroalkane (HFA) formulations of fluticasone/salmeterol in health volunteers via pMDI alone and spacer. Br J Clin Pharmacol. 2010;69:637–44.
    • (2010) Br J Clin Pharmacol , vol.69 , pp. 637-644
    • Clearie, K.L.1    Williamson, P.A.2    Vaidyanathan, S.3    Du Bois, J.4    Nell, H.5    Lipworth, B.J.6
  • 33
    • 0030987528 scopus 로고    scopus 로고
    • Airway deposition and airway effects of antiasthma drugs delivered from metered-dose inhalers
    • COI: 1:CAS:528:DyaK2sXms1Siu78%3D, PID: 9311516
    • Pauwels R, Newman S, Borgström L. Airway deposition and airway effects of antiasthma drugs delivered from metered-dose inhalers. Eur Respir J. 1997;10:2127–38.
    • (1997) Eur Respir J , vol.10 , pp. 2127-2138
    • Pauwels, R.1    Newman, S.2    Borgström, L.3
  • 34
    • 0034097509 scopus 로고    scopus 로고
    • Demonstration of in vivo bioequivalence of a generic albuterol metered-dose inhaler to Ventolin
    • COI: 1:CAS:528:DC%2BD3cXitlWmtLs%3D, PID: 10712996
    • Stewart BA, Ahrens RC, Carrier S, Frosolono M, Lux C, Han SH, et al. Demonstration of in vivo bioequivalence of a generic albuterol metered-dose inhaler to Ventolin. Chest. 2000;117:714–21.
    • (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
  • 35
    • 84962772204 scopus 로고    scopus 로고
    • A double blind placebo controlled study to assess the effect of roflumilast in addition to LABA/LAMA/ICS treatment in COPD patients using novel biomarkers
    • De Backer J. A double blind placebo controlled study to assess the effect of roflumilast in addition to LABA/LAMA/ICS treatment in COPD patients using novel biomarkers. IPAC-RS/UF Inhalation Conference in Orlando. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 13 Nov 2014.
    • (2014) IPAC-RS/UF Inhalation Conference in Orlando
    • De Backer, J.1
  • 36
    • 84905639968 scopus 로고    scopus 로고
    • The effect of roflumilast in addition to LABA/LAMA/ICS treatment in COPD patients
    • PID: 24791831
    • De Backer W, Vos W, Van Holsbeke C, Vinchurkar S, Claes R, Hufkens A, et al. The effect of roflumilast in addition to LABA/LAMA/ICS treatment in COPD patients. Eur Respir J. 2014;44:527–9.
    • (2014) Eur Respir J , vol.44 , pp. 527-529
    • De Backer, W.1    Vos, W.2    Van Holsbeke, C.3    Vinchurkar, S.4    Claes, R.5    Hufkens, A.6
  • 37
    • 84883055167 scopus 로고    scopus 로고
    • Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT®)
    • COI: 1:STN:280:DC%2BC3snnslGitA%3D%3D, PID: 23714653
    • Janssens W, Liu Y, Liu D, Kesten S, Tashkin DP, Celli BR, et al. Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT®). Respir Med. 2013;107:1409–16.
    • (2013) Respir Med , vol.107 , pp. 1409-1416
    • Janssens, W.1    Liu, Y.2    Liu, D.3    Kesten, S.4    Tashkin, D.P.5    Celli, B.R.6


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