PharmPK Discussion - Bioequivalence of inhalation products

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On 16 Jan 2000 at 18:00:18, Gary Maier (gmaier.-a-.sepracor.com) sent the message


Hello,

I was wondering how bioequivalence can be demonstrated for generic
inhalation products.

Thanks,
Gary Maier

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On 26 Jan 2000 at 00:02:09, "medical" (medical.aaa.wilnetonline.net) sent the message


I feel that for this there are two ways, the first being since there will be
some amount of systemic absorption,the drug levels in the plasma can be
compared as is done for standard testing.
The second way would be by pharmacodynamic parameters eg if two
bronchodilators are being compared,the bronchodilator responses can be
measured by way of serial FEV1 measurements and this parameter can be
compared in the two groups.Of course this model will have to be validated in
pilot studies first.
Amit Taneja

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