Commentary on the FDA draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action: an industry view.
In June 1999, the Food and Drug Administration issued draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action. The purpose of this opinion paper is to highlight the need for a balanced scientific debate before this guidance is used by underscoring the areas in the document that are in opposition to prevailing scientific understanding.
Harrison
L I
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Department of Pharmacokinetics and Drug Metabolism, 3M Pharmaceuticals, St. Paul, Minnesota, USA.
D000042:Absorption; D000336:Aerosols / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D016503:Drug Delivery Systems; D017408:Guidelines as Topic; D006801:Humans; D010316:Particle Size; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D000336:Aerosols