PharmPK Discussion - Bioequivalence of inhaled formoterol

• On 9 Mar 2007 at 14:13:57, "Paula Macedo Cerqueira" (paulamacedo.cerqueira.-at-.gmail.com) sent the message
  

  
  Dear All,
  
  Does anyone have experience in conducting bioequivalence studies of
  inhaled formoterol and/or formoterol associated to mometasone?
  According to some publications it is easier to quantify formoterol in
  urine than in plasma, but a bioequivalence study in urine does not
  seem a good alternative to me (it would be the last!).
  Any comment would be very helpful!
  Paula
  
  --
  Dra. Paula Macedo Cerqueira
  Wissen Consultores Associados
  Sao Paulo - Brazil
  
  

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• On 12 Mar 2007 at 10:26:30, "Fadiran, Emmanuel O" (emmanuel.fadiran.-at-.fda.hhs.gov) sent the message
  

  
  The following message was posted to: PharmPK
  
  Because of the local effect of these inhaled products (LABAs and/or
  corticosteroids) the bioequivalence approach cannot be used for their
  approval. The systemic exposure from these inhaled products is used for
  safety assessment (not efficacy) and it is intentionally limited to
  minimize the systemic safety. Plasma concentrations of formoterol are
  very low following inhalation of the therapeutic dose but urinary
  concentrations are measurable - refer to the approved labeling for
  Foradil Aerolizer for additional information.
  
  Tayo
  --
  Emmanuel O. Fadiran, R.Ph., Ph.D.
  Team Leader, Pulmonary & Allergy Products
  Division of Clinical Pharmacology 2, OCP, FDA
  Building 21, Room 4672
  10903 New Hampshire Avenue, Silver Spring, MD 20993-0002
  Phone: 310-796-1529
  Fax:    310-796-9741
  E-mail: emmanuel.fadiran.-a-.fda.hhs.gov
  
  

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