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Generic inhalers for asthma

Pearson, Mike ; Lewis, Richard ; Watson, John ; Ayres, Jon ; Ibbotson, Geoff ; Flynn, Dermot Ryan David ; Williams, Jeff

BMJ, 1994-11, Vol.309 (6966), p.1440-1440 [Periódico revisado por pares]

England: British Medical Association

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Título:
Generic inhalers for asthma
Autor: Pearson, Mike ; Lewis, Richard ; Watson, John ; Ayres, Jon ; Ibbotson, Geoff ; Flynn, Dermot Ryan David ; Williams, Jeff
Assuntos: Asthma ; Asthma - drug therapy ; Bronchodilator Agents - pharmacokinetics ; Conflicts of interest ; Drugs, Generic - pharmacokinetics ; Generic products ; Humans ; Inhalers ; Letter ; Letters ; Medical specialists ; Meetings ; Nebulizers and Vaporizers ; Pharmaceutical industry ; Pharmaceutical preparations ; Physicians ; Sponsorship ; Therapeutic Equivalency
É parte de: BMJ, 1994-11, Vol.309 (6966), p.1440-1440
Notas: SourceType-Other Sources-1
ObjectType-Article-2
content type line 63
ObjectType-Correspondence-1
Descrição: [...]the Food and Drug Administration in the United States recommends that both the safety and efficacy of generic salbutamol inhalers should be evaluated clinically to show equivalence to the branded products. While new regulations in Britain also ask for such in vivo data, these requirements are not retrospective. [...]the principal in vitro test on which generic inhalers have been licensed-the twin impinger technique-simply divides the aerosol cloud into "respirable" and "non-respirable" fractions and cannot apparently detect differences in the quantity of the very fine particles that penetrate to peripheral airways. 1 Clinical data comparing branded and generic salbutamol products are few; we know of five published studies, none of which support bioequivalence. 2 3 Similarly, there are good data on branded inhaled steroids but none on the bioequivalence of the generic products.
Editor: England: British Medical Association
Idioma: Inglês

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Generic inhalers for asthma

Pearson, Mike ; Lewis, Richard ; Watson, John ; Ayres, Jon ; Ibbotson, Geoff ; Flynn, Dermot Ryan David ; Williams, Jeff

England: British Medical Association

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