REMINDER
KEELE UNIVERSITY
CENTRE FOR MEDICAL STATISTICS
SEMINAR SERIES on BIOSTATISTICS 2002/2003
NO 9: Wednesday, May 28th 2003, at 2:30 pm
Statistical Analysis of Assessing Equivalence in Regulatory Drug
Submissions
Dr Richard Kay BSc, MSc, PhD
Vice President, Parexel
For scientific, ethical and commercial reasons it is increasingly the
case that pharmaceutical companies are undertaking equivalence or
non-inferiority trials rather than superiority trials to establish
efficacy. This presentation will present the appropriate statistical
methodology and discuss the practical difficulties of this framework.
Issues that will be addressed will include: assay sensitivity, choice of
equivalence margins, analysis sets and sample size implications.
Venue: Room 2.22, Third Floor, MacKay Building, Keele University - All
welcome!!
http://www.keele.ac.uk/cwis.html
http://www.keele.ac.uk/depts/ma/news/#medstats
http://www.keele.ac.uk/university/campus/cgm.pdf
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Janet Drewery
Centre for Medical Statistics
Mathematics Department
MacKay Building
Keele University
Keele, Staffs ST5 5BG
Tel: (01782) 583269
Fax: (01782) 584268
E-mail: [log in to unmask]
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