Characterizing systemic exposure of inhaled drugs: Application to the long-acting β2-Agonist PF-00610355

Clinical Pharmacokinetics

Volumn 52, Issue 6, 2013, Pages 443-452

  Diderichsen, Paul Matthias ^a   Cox, Eugène ^a   Martin, Steven W ^b   Cleton, Adriaan ^c,d   Ribbing, Jakob ^b  

^a Certara Company   (Netherlands)

^b PFIZER INC   (United States)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^d ASTRAZENECA R AND D   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

BETA 2 ADRENERGIC RECEPTOR; PF 00610355; UNCLASSIFIED DRUG;

ARTICLE; ASTHMA; CHRONIC OBSTRUCTIVE LUNG DISEASE; COMPARTMENT MODEL; CONCENTRATION (PARAMETERS); DEMOGRAPHY; DRUG DISPOSITION; DRUG EXPOSURE; HUMAN; INHALER; LUNG FUNCTION; MAJOR CLINICAL STUDY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; ASTHMA; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; HEART RATE; HUMANS; LUNG; MODELS, BIOLOGICAL; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS; TISSUE DISTRIBUTION;

EID: 84878679898     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-013-0048-7     Document Type: Article

References (16)

1. Pauwels RA, Buist AS, Calverley PM, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001;163:1256-76.
2. Boyd G, Morice AH, Pounsford JC, et al. An evaluation of salmeterol in the treatment of chronic obstructive pulmonary disease (COPD). Eur Respir J. 1997;10:815-21.
3. Rossi A, Kristufek P, Levine BE, et al. Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest. 2002;121:1058-69.
4. Shrewsbury S, Pyke S, Britton M. Meta-analysis of increased dose of inhaled steroid or addition of salmeterol in symptomatic asthma (MIASMA). BMJ. 2000;320:1368-73.
5. Beier J, Beeh KM. Long-acting beta-adrenoceptor agonists in the management of COPD: focus on indacaterol. Int J Chron Obstruct Pulmon Dis. 2011;6:237-43.
6. Glossop PA, Lane CA, Price DA, et al. Inhalation by design: novel ultra-long-acting β(2)-adrenoreceptor agonists for inhaled once-daily treatment of asthma and chronic obstructive pulmonary disease that utilize a sulfonamide agonist headgroup. J Med Chem. 2010;53(18):6640-52.
7. Weda M, Zanen P, de Boer AH, et al. The therapeutic index of locally acting inhaled drugs as a function of their fine particle mass and particle size distribution: a literature review. Curr Drug Deliv. 2008;5:142-7.
8. Diderichsen PM, Cox E, Martin SW, et al. Predicted heart rate effect of inhaled PF-00610355, a long acting beta-adrenoceptor agonist, in volunteers and patients with chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2013. doi: 10.1111/bcp.12080.
9. Savic RM, Karlsson MO. Importance of shrinkage in empirical Bayes estimates for diagnostics: problems and solutions. AAPS J. 2009;11:558-69.
10. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm. 1993;21:735-50.
11. Lindbom L, Pihlgren P, Jonsson EN. PsN-Toolkit - a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005;79:241-57.
12. R Development Core Team. R: a language and environment for statistical computing. http://www.R-project.org; 2011.
13. Savic RM, Jonker DM, Kerbusch T, et al. Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J Pharmacokinet Pharmacodyn. 2007;34:711-26.
14. Patton JS, Byron PR. Inhaling medicines: delivering drugs to the body through the lungs. Nat Rev Drug Discov. 2007;6(1):67-74.
15. Matsushima S, Matthews I, Woessner R, Pinault G, Hara H, Wilkins J, Sekiguchi K. Systemic pharmacokinetics of indacaterol, an inhaled once-daily long-acting beta2-agonist, in different ethnic populations. Int J Clin Pharmacol Ther. 2012;50:545-56.
16. Bennett JA, Harrison TW, Tattersfield AE. The contribution of the swallowed fraction of an inhaled dose of salmeterol to it systemic effects. Eur Respir J. 1999;13:445-8.