The authors respond

Clinical Therapeutics

Volumn 32, Issue 5, 2010, Pages 997-1000

  Daley Yates, Peter T ^a   Parkins, David A ^a   Thomas, Marian J ^a   Gillett, Benjamin ^a   House, Karen W ^b   Ortega, Hector G ^b  

^a GLAXOSMITHKLINE   (United Kingdom)

^b GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BECLOMETASONE DIPROPIONATE; BUDESONIDE; FLUNISOLIDE; FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; SALBUTAMOL;

ASTHMA; BIOEQUIVALENCE; DISEASE SEVERITY; DRUG EFFICACY; FLOW RATE; FORCED EXPIRATORY VOLUME; HUMAN; INHALER; LETTER; LUNG FUNCTION; PARTICLE SIZE;

EID: 77954777803     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(10)00182-7     Document Type: Letter

References (6)

1. Daley-Yates PT, Parkins DA, Thomas MJ, et al. 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 μg and fluticasone propionate 250 μg: Implications for establishing bioequivalence of inhaled products. Clin Ther. 2009, 31:370-385.
2. 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 European Medicines Agency, Accessed March 10, 2010. http://www.ema.europa.eu/pdfs/human/ewp/4850108en.pdf.
3. Tarsin W, Assi KH, 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.
4. Prime D, Grant AC, Slater AL, Woodhouse RN A critical comparison of the dose delivery characteristics of four alternative inhalation devices delivering salbutamol: Pressurised metered dose inhaler, Diskus inhaler, Diskhaler inhaler, and Turbuhaler inhaler. J Aerosol Med. 1999, 12:75-84.
5. Tarsin WY, Pearson SB, Assi KH, Chrystyn H Emitted dose estimates for Seretide Diskus and Symbicort Turbuhaler following inhalation by severe asthmatics. Int J Pharm. 2006, 316:131-137.
6. Multicentre A GlaxoSmithKline Clinical Trial Register Study No: RPS30001/SFCF3002 Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to Establish Equivalence of the Fluticasone Propionate/Salmeterol Combination (FSC) Product (100/50μg) via Either the Reservoir Powder Inhalation Device (RPID) or via the Diskus* Inhaler over 12 Weeks in Children with Asthma, Accessed March 10, 2010. http://www.gsk-clinicalstudyregister.com/files/pdf/980.pdf.