Rethinking bioequivalence and equivalence requirements of orally inhaled drug products

Asian Journal of Pharmaceutical Sciences

Volumn 10, Issue 6, 2015, Pages 461-471

  Al Numani, Dina ^a   Colucci, Philippe ^a   Ducharme, Murray P ^a,b  

^a Learn and Confirm Inc   (Canada)

^b UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

Bioequivalence; Clinical endpoint studies; Inhalation products; Pharmacodynamics; Pharmacokinetics; Therapeutic equivalence

Indexed keywords

BRONCHODILATING AGENT; CORTICOSTEROID; GENERIC DRUG;

ASTHMA; BIOEQUIVALENCE; CHRONIC OBSTRUCTIVE LUNG DISEASE; DRUG EFFICACY; DRY POWDER INHALER; HUMAN; PHARMACOKINETIC PARAMETERS; REVIEW; THERAPEUTIC EQUIVALENCE;

EID: 84959499488     PISSN: 18180876     EISSN: 2221285X     Source Type: Journal    
DOI: 10.1016/j.ajps.2015.08.006     Document Type: Review

References (61)

1. Lipworth B.J. Pharmacokinetics of inhaled drugs. Br J Clin Pharmacol 1996, 42(6):697-705.
2. Rubin B.K. Air and soul: the science and application of aerosol therapy. Respir Care 2010, 55(7):911-921.
3. Masoli M., Fabian D., Holt S., et al. Global burden of asthma - developed for the global initiative for asthma accessed 28.06.15. http://www.ginasthma.org/local/uploads/files/GINABurdenReport_1.pdf.
4. Masoli M., Fabian D., Holt S., et al. Global initiative for asthma (GINA) - Global strategy for asthma management and prevention accessed 28.06.15. http://www.ginasthma.org/local/uploads/files/GINA_Report_2015_May19.pdf.
5. Juniper E.F., Kline P.A., Vanzieleghem M.A., et al. Effect of long-term treatment with an inhaled corticosteroid (budesonide) on airway hyperresponsiveness and clinical asthma in nonsteroid-dependent asthmatics. Am Rev Respir Dis 1990, 142(4):832-836.
6. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med 2000, 343(15):1054-1063. The Childhood Asthma Management Program Research Group.
7. Jeffery P.K., Godfrey R.W., Adelroth E., et al. Effects of treatment on airway inflammation and thickening of basement membrane reticular collagen in asthma. A quantitative light and electron microscopic study. Am Rev Respir Dis 1992, 145(4 Pt 1):890-899.
8. Suissa S., Ernst P., Benayoun S., et al. Low-dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med 2000, 343(5):332-336.
9. Hizawa N. LAMA/LABA vs ICS/LABA in the treatment of COPD in Japan based on the disease phenotypes. Int J Chron Obstruct Pulmon Dis 2015, 10:1093-1102.
10. Global Initiative for Chronic Obstructive Lung Disease (GOLD) Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease accessed 30.06.15. http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015.pdf.
11. Aitken M., Berndt E.R., Cutler D. Prescription drug spending trends in the United States: looking beyond the turning point. Health Aff 2009, 28(1):w151-w160.
12. US Food and Drug Administration Facts about generic drugs - 2015 accessed 16.08.15. http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm.
13. The Canadian Generic Pharmaceutical Association (CGPA) The Canadian generic market year accessed 26.06.15. http://www.canadiangenerics.ca/en/resources/market_trends.asp.
14. US Food and Drug Administration Challenges and opportunities report - March 2004 accessed 08.07.15. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm#f5.
15. US Food and Drug Administration Guidance for industry. Bioavailability and bioequivalence studies for orally administered drug products - general considerations accessed 01.07.15. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM154838.pdf.
16. US Food and Drug Administration Guidance for industry. Metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products. Chemistry, manufacturing, and controls documentation 1998, accessed 08.07.15. http://www.fda.gov/downloads/Drugs/Guidances/ucm070573.pdf.
17. US Food and Drug Administration Draft guidance on budesonide accessed 08.07.15. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319977.pdf.
18. US Food and Drug Administration Draft guidance on albuterol sulfate accessed 05.07.15. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm346985.pdf.
19. US Food and Drug Administration Draft guidance on fluticasone propionate; salmeterol xinafoate accessed 08.07.15. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM367643.pdf.
20. Lee S. Scientific and regulatory considerations for bioequivalence (BE) of dry powder inhalers (DPIs) US Food and Drug Administration, Office of Generic Drugs, accessed 08.07.15. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM292652.pdf.
21. Lee S.L., Saluja B., García-Arieta A., et al. Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India. AAPS J 2015, 17(5):1285-1304. 10.1208/s12248-015-9787-8.
22. Hochhaus G., Davis-Cutting C., Oliver M., et al. Current scientific and regulatory approaches for development of orally inhaled and nasal drug products: overview of the IPAC-RS/University of Florida Orlando Inhalation Conference. AAPS J 2015, 17(5):1305-1311. 10.1208/s12248-015-9791-z.
23. Health Canada Guidance to establish equivalence or relative potency of safety and efficacy of a second entry short-acting beta2-agonist metered dose inhaler accessed 08.07.15. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/mdi_bad-eng.pdf.
24. Health Canada Guidance for industry - pharmaceutical quality of inhalation and nasal products accessed 08.07.15. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/inhalationnas-eng.pdf.
25. Health Canada Draft guidance document - data requirements for safety and effectiveness of subsequent market entry inhaled corticosteroid products for use in the treatment of asthma for industry accessed 08.07.15. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/draft_inhal_ebauche_corticost-eng.pdf.
26. European Medicines Agency 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 for use in the treatment of asthma in children and adolescents accessed 08.07.15. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003504.pdf.
27. European Medicines Agency Guideline on the pharmaceutical quality of inhalation and nasal products accessed 08.07.15. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003568.pdf.
28. US Food and Drug Administration Product label for Flovent Diskus (fluticasone propionate inhalation powder 50, 100, and 250 mcg) GlaxoSmithKline, accessed 09.07.15. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020833s028lbl.pdf.
29. Auclair B., Wainer I.W., Fried K., et al. A population analysis of nebulized (R)-Albuterol in dogs using a novel mixed gut-lung absorption PK-PD model. Pharm Res 2000, 17(10):1228-1235.
30. Goldstein D.A., Tan Y.K., Soldin S.J. Pharmacokinetics and absolute bioavailability of salbutamol in healthy adult volunteers. Eur J Clin Pharmacol 1987, 32(6):631-634.
31. Du X.L., Zhu Z., Fu Q., et al. Pharmacokinetics and relative bioavailability of salbutamol metered-dose inhaler in healthy volunteers. Acta Pharmacol Sin 2002, 23(7):663-666.
32. Mager D.E., Jusko W.J. Development of translational pharmacokinetic-pharmacodynamic models. Clin Pharmacol Ther 2008, 83:909-912.
33. Seng Yue C., Ducharme M.P., D'Angelo P. Pharmacodynamics. International pharmaceutical product registration 2009, Informa Healthcare USA, Inc., New York. A.C. Cartwright, B.R. Matthews (Eds.).
34. US Food and Drug Administration Draft guidance on orlistat accessed 08.07.15. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm201268.pdf.
35. Barnes P.J., Adcock I.M. How do corticosteroids work in asthma?. Ann Intern Med 2003, 139:359-370.
36. O'Connor D., Adams W.P., Chen M.L., et al. Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report. J Aerosol Med Pulm Drug Deliv 2011, 24(3):119-135.
37. Vijverberg S.J., Koenderman L., Koster E.S., et al. Biomarkers of therapy responsiveness in asthma: pitfalls and promises. Clin Exp Allergy 2011, 41(5):615-629.
38. American Thoracic Society (ATS), European Respiratory Society (ERS) 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(8):912-930.
39. Hendeles L., Daley-Yates P.T., Hermann R., et al. Pharmacodynamic studies to demonstrate bioequivalence of oral inhalation products. AAPS J 2015, 17(3):758-768.
40. Lee S.L. Investigation of dose-response of exhaled nitric oxide following oral inhalation of fluticasone propionate. 2012 2012, Presented at; 2012 GPhA/FDA Fall Technical Conference; Oct 02.
41. Gelb A.F., Moridzadeh R., Singh D.H., et al. In moderate-to-severe asthma patients monitoring exhaled nitric oxide during exacerbation is not a good predictor of spirometric response to oral corticosteroid. J Allergy Clin Immunol 2012, 129:1491-1498.
42. Barnes P.J., Dweik R.A., Gelb A.F., et al. Exhaled nitric oxide in pulmonary diseases. Chest 2010, 138(3):682-692.
43. Green R.H., Brightling C.E., Woltmann G., et al. Analysis of induced sputum in adults with asthma: identification of subgroup with isolated sputum neutrophilia and poor response to inhaled corticosteroids. Thorax 2002, 57:875-879.
44. Szefler S.J., Martin R.J., King T.S., et al. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol 2002, 109:410-418.
45. Berry M., Morgan A., Shaw D.E., et al. Pathological features and inhaled corticosteroid response of eosinophilic and non-eosinophilic asthma. Thorax 2007, 62:1043-1049.
46. Pavord I.D., Brightling C.E., Woltmann G., et al. Non-eosinophilic corticosteroid unresponsive asthma. Lancet 1999, 353:2213-2214.
47. Meijer R.J., Postma D.S., Kauffman H.F., et al. Accuracy of eosinophils and eosinophil cationic protein to predict steroid improvement in asthma. Clin Exp Allergy 2002, 32:1096-1103.
48. Godon P., Boulet L.P., Malo J.L., et al. Assessment and evaluation of symptomatic steroid-naive asthmatics without sputum eosinophilia and their response to inhaled corticosteroids. Eur Respir J 2002, 20:1364-1369.
49. Little S.A., Chalmers G.W., MacLeod K.J., et al. Non-invasive markers of airway inflammation as predictors of oral steroid responsiveness in asthma. Thorax 2000, 55:232-234.
50. Lex C., Jenkins G., Wilson N.M., et al. Does sputum eosinophilia predict the response to systemic corticosteroids in children with difficult asthma?. Pediatr Pulmonol 2007, 42:298-303.
51. Martin R.J., Szefler S.J., King T.S., et al. Predicting response to inhaled corticosteroid efficacy (PRICE) trial. J Allergy Clin Immunol 2007, 119:410-418.
52. Ducharme M.P. Dose-scale pharmacodynamic bioequivalence studies - practical considerations 2014, Presented at; the AAPS Annual Meeting, San Diego, CA, USA; Nov 6.
53. Daley-Yates P.T., Parkins D.A. Establishing bioequivalence for inhaled drugs; weighing the evidence. Expert Opin Drug Deliv 2011, 8(10):1297-1308.
54. Persson G., Ankerst J., Gillen M., et al. Relative systemic availability of budesonide in patients with asthma after inhalation from two dry powder inhalers. Curr Med Res Opin 2008, 24(5):1511-1517.
55. Kerwin E.M., Pearlman D.S., de Guia T., et al. Evaluation of efficacy and safety of budesonide delivered via two dry powder inhalers. Curr Med Res Opin 2008, 24(5):1497-1510.
56. Lawrence M., Wolfe J., Webb D.R., et al. Efficacy of inhaled fluticasone propionate in asthma results from topical and not from systemic activity. Am J Respir Crit Care Med 1997, 156(3 Pt 1):744-751.
57. Patton J.S., Fishburn C.S., Weers J.G. The lungs as a portal of entry for systemic drug delivery. Proc Am Thorac Soc 2004, 1(4):338-344.
58. Hindle M., Chrystyn H. Determination of the relative bioavailability of salbutamol to the lung following inhalation. Br J Clin Pharmacol 1992, 34(4):311-315.
59. Morgan D.J., Paull J.D., Richmond B.H., et al. Pharmacokinetics of intravenous and oral salbutamol and its sulphate conjugate. Br J Clin Pharmacol 1986, 22(5):587-593.
60. Martin R.J., Kraft M., Beaucher W.N., et al. Comparative study of extended release albuterol sulfate and long-acting inhaled salmeterol xinafoate in the treatment of nocturnal asthma. Ann Allergy Asthma Immunol 1999, 83(2):121-126.
61. Wu K., Blomgren A.L., Ekholm K., et al. Budesonide and ciclesonide: effect of tissue binding on pulmonary receptor binding. Drug Metab Dispos 2009, 37(7):1421-1426.