FDA Guidance for Industry: Statistical Information from the June 1999 Draft Guidance and Statistical Information for in Vitro Bioequivalnce Data Posted on August 18, 1999 - General Considerations
Title:
FDA Guidance for Industry: Statistical Information from the June 1999 Draft Guidance and Statistical Information for in Vitro Bioequivalnce Data Posted on August 18, 1999 - General Considerations
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070118.pdf
Content:
Statistical analysis method recommendations for in vitro nonprofile bioequivalence data, to accompany the draft guidance for industry entitled Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (April 2, 2003), are under development