Sensitive studies with a significant dose-response curve for inhaled corticosteroids to investigate equivalent relative potency are feasible

British Journal of Clinical Pharmacology

Volumn 72, Issue 5, 2011, Pages 832-833

  García Arieta, Alfredo ^a  

^a Department of Human Use Medicines   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; CORTICOSTEROID; METHACHOLINE; NITRIC OXIDE;

DATA ANALYSIS; DOSE RESPONSE; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; LETTER; MAXIMUM PLASMA CONCENTRATION; PATIENT SELECTION; PRACTICE GUIDELINE; PRIORITY JOURNAL; STUDY DESIGN; TIME TO MAXIMUM PLASMA CONCENTRATION;

AEROSOL PROPELLANTS; ASTHMA; BRONCHODILATOR AGENTS; BUDESONIDE; CHLOROFLUOROCARBONS; FEMALE; HUMANS; HYDROCARBONS, FLUORINATED; MALE;

EID: 80053898113     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2011.04017.x     Document Type: Letter

References (3)

1. Clearie KL, Williamson PA, Meldrum K, Gillen M, Carlsson LG, Carlholm M, Ekelund J, Lipworth BJ. Pharmacokinetic and pharmacodynamic comparison of hydrofluoroalkane and chlorofluorocarbon formulations of budesonide. Br J Clin Pharmacol 2011; 71: 504-13.
2. Kelly MM, Leigh R, Jayaram L, Goldsmith CH, Parameswaran K, Hargreave FE. Eosinophilic bronchitis in asthma: a model for establishing dose-response and relative potency of inhaled corticosteroids. J Allergy Clin Immunol 2006; 117: 989-94.
3. Committee for Human Medicinal Products (CHMP), 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 and for use in the treatment of asthma in children and adolescents. 22-1-2009.