Establishing bioequivalence for orally inhaled drug products

Expert Opinion on Drug Delivery

Volumn 8, Issue 11, 2011, Pages 1531-1532

  Daley Yates, Peter T ^a   Parkins, David A ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

FLUTICASONE PROPIONATE;

BIOEQUIVALENCE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG SOLUBILITY; IN VITRO STUDY; INHALATIONAL DRUG ADMINISTRATION; LETTER; PARTICLE SIZE;

ADMINISTRATION, INHALATION; AEROSOLS; HUMANS;

EID: 80054793764     PISSN: 17425247     EISSN: 17447593     Source Type: Journal    
DOI: 10.1517/17425247.2011.617538     Document Type: Letter

References (5)

1. 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
2. Daley-Yates PT, Parkins DA. Establishing bioequivalence for inhaled drugs; weighing the evidence. Expert Opin Drug Deliv 24 June 2011. [Epub ahead of print]
3. 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
4. Lawrence M, Wolfe J, Webb DR, et al. 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 (Pubitemid 27396410)
5. Rowland M, Tozer TN. Clinical pharmacokinetics concepts and applications. 4th edition. Williams & Wilkins; Lippincott: 2011. p. 561-602