Generic inhaled drugs: how to evaluate their properties?
Abstract
Generic inhaled drugs: how to evaluate their properties?
About the Authors
S. K. Zyryanov
ГБОУ ВПО "Российский национальный исследовательский медицинский университет им. Н.И.Пирогова"
Russian Federation
Russian Federation
Z. R. Aisanov
ФГУ "НИИ пульмонологии" ФМБА России
Russian Federation
Russian Federation
References
1. FDA. Orange book: Approved drug products with therapeutic equivalence evaluations. 30th ed.; 2010.
2. Белоусов Ю.Б., Зырянов С.К. Дженерики и бренды: pro et contra. Качеств. клини. практ. 2003; 2: 95–100.
3. Daley'Yates P.T., Parkins D.A. Establishing bioequivalence for inhaled drug, weighing the evidence. Expert. Opin. Drug Deliv. 2011; 1: 112.
4. European Medicines Agency. Committee for Medicinal Products for Human Use. 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 Doc. Ref. CPMP/ EWP/4151/00 Rev. 1. Jan. 2009. London; 2009.
5. Lawrence M., Wolfe J., Webb D.R. 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: 744–751.
6. Clearie K.I., Williamson P.A., Vaidyanathan S. et al. Systemic bioavailability of hydrofluoroalkane formulation of fluticasone / salmeterol in healthy volunteers via pMDI alone and spacer. Br. J. Clin. Pharmacol. 2010; 69: 637–644.
7. Информационное письмо-обращение экспертов Российского респираторного общества к врачам первичного звена и специалистам в области пульмонологии. Пульмонология 2011; 6; 119.
Review
For citations:
Zyryanov S.K., Aisanov Z.R. Generic inhaled drugs: how to evaluate their properties? PULMONOLOGIYA. 2012;(3):115-118. (In Russ.)
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