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Dear all,
Nasal inhalers are required BE studies. If so, what is the procedure
to conduct BE study. Is there any special precaution for this type of
studies. any information is valuable for me.
regards,
E.Srinivasa Reddy,
Research Analyst
Pharmacokinetics and Statistics Department
Bioserve Clinical Research Pvt.Ltd
Balanagar, Hyderabad, AP, India
email: esreddy.at.bioserve.co.in
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Hi Srinivasa,
The bioequivalence requirements for nasal
formulations for local action are much different than classical
bioequivalence approach adopted for most of the peroral
formulations.
Within nasal formulations itself requirements are
different based on the type of the formulations: Suspension vs. Solution
nasal formulations.For solution based nasal formulations, an in-vitro
bioequivalence ( equivalence of droplet size distribution by spraytec at
different distance, plume characteristics, spray pattern,SCU etc.) will
be sufficient enough and clinical studies may not be required.For
suspension based formulations, bioequivalence has to be established
based on clinical study end points.More often a PK based classical BE
approach is not relevent to most of nasal formulations for local
applications and sometime this is limited by blood concentration below
detection limit which may or may not be relevent for therapeutic
response. In specific cases like corticosteroids , an equivalence of
systemic exposure data is also required in addition to bioequivalence
based on clinical end point.
Please go through the following draft
guidance document issued by FDA for more
details:
http://www.fda.gov/cder/guidance/2070dft.pdf
Kind
regards,
Pradeep Bhadauria
Product Development Scientist
Sandoz
Inc. ( a Novartis company)
4700, Sandoz drive.
Wilson,NC 27893,USA.
Phone: 252-234-2342
Fax : 252-234-2280
www.us.sandoz.com
www.novartis.com
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Dear E. S. Reddy,
If you mean nasal sprays for topical action, the FDA has a BA/BE
draft guidance and some supplemental information on statistics on
their web site.
If you mean nasal inhalation for dosing to the lungs, then the
situation is less well defined, and may require combining comparisons
of the inhalation and the nasal aspects.
Frank
frankbales.aaa.msn.com
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)