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Letters to the Editor

Establishing bioequivalence for orally inhaled drug products

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Pages 1531-1532 | Published online: 18 Oct 2011

Bibliography

  • 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
  • Daley-Yates PT, Parkins DA. Establishing bioequivalence for inhaled drugs; weighing the evidence. Expert Opin Drug Deliv 24 June 2011. [Epub ahead of print]
  • Daley-Yates PT. The clinical utility of pharmacokinetics: theoretical consideration across drug classes. In: Dalby RN, Byron PR, Peart J, Suman JD, Farr SJ, Young PM. editors. Respiratory Drug Delivery. ISBN: Book 1, 1-933722-41-X. David Healthcare International Publishing; Orlando Florida, River Grove IL: 2010. p. 273-84
  • 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
  • Rowland M, Tozer TN. Clinical pharmacokinetics concepts and applications. 4th edition. Williams & Wilkins; Lippincott: 2011. p. 561-602

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