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Commentary on the FDA Draft Guidance for Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action: An Industry View
Author(s) -
Harrison Lester I.
Publication year - 2000
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700022009440
Subject(s) - bioequivalence , food and drug administration , nasal spray , medicine , opposition (politics) , action (physics) , abuse liability , clinical pharmacology , pharmacology , nasal administration , drug , political science , pharmacokinetics , law , politics , physics , quantum mechanics
In June 1999, the Food and Drug Administration issued draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action.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.