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Dear All
Is anyone have an idea about BE studies of 'metered dose
inhalers' (anti-asthma) particularly related to:
1) Design of BE study related to clinical conduction.
2) Which parameters we need to consider to conclude bio-equivalence.
3) Statistical analysis
Thanks and Regards,
Yogesh Sonawane,
Biostatistician,
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Re BE studies of MDI's
Yogesh,
There is specific guidance regarding clinical trials for CFC to HFA
propellant switch
http://www.fda.gov/cder/guidance/old046fn.pdf
There is also specific guidance regarding Nasal BA/BE
http://www.fda.gov/cder/guidance/5383DFT.pdf
I have also heard a podium guidance to refer to the nasal guidance for
MDI's and DPI's, and to not expect any additional guidance to be
released for these products this year.
That same podium presentation stated that there has only been one
generic approved so far by the FDA for nasal/pulmonary products, and
that is a nasal spray, (Flonase).
Frank
Frank Bales, Ph.D.
Email: frankbales.at.msn.com
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The following message was posted to: PharmPK
Dear Yogesh,
as long as you consider local pulmonary treatment with the metered dose
(e.g. by a bronchodilator like salbutamol or by a steroid like
beclomethasone), bioequivalence via concentrations measured in plasma
make no sense for efficacy, only for systemic safety. In this case of
you will have to establish bioequivalence via a clinical efficacy study
(there are some older, but valid guidances available).
Kind regards,
Dietrich
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