Clinically relevant test methods to establish in vitro equivalence for spacers and valved holding chambers used with pressurized metered dose inhalers (pMDIs)

Regulatory guidance in Canada and Europe recommends that the manufacturer of an inhaled drug product delivered by pressurized metered-dose inhaler (pMDI) identify a spacer (S) or valved holding chamber (VHC) to be used with their designated product. It therefore becomes necessary to include the S/VH...

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Veröffentlicht in:	Journal of aerosol medicine 2012-08, Vol.25 (4), p.217-242
Hauptverfasser:	Mitchell, Jolyon, Dolovich, Myrna B
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Inhalation Canada Equipment Design - standards Health technology assessment Humans In Vitro Techniques Materials Testing - methods Metered Dose Inhalers - standards Particle Size Pharmaceutical Preparations - administration & dosage Quality Control
Online-Zugang:	Volltext
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