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Letters to the Editor

Establishing bioequivalence for orally inhaled drug products

Pages 1533-1534 | Published online: 18 Oct 2011

Bibliography

  • Daley-Yates PT, Parkins DA. Establishing bioequivalence for inhaled drugs. Expert Opin Drug Deliv 2011;8(10):1297-308
  • Committee for Human Medicinal Products (CHMP) EMA. 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. 2009
  • Committee for Medicinal Products for Human Use (CHMP). Guideline on the investigation of bioequivalence. European Medicines Agency (EMA); London: 2010
  • Lawrence M, Wolfe J, Webb DR, 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):744-51
  • Derendorf H, Hochhaus G, Meibohm B, Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J Allergy Clin Immunol 1998;101(4 Pt 2):S440-6

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