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Dear Alain,
Although I have no experience of conducting this type of study myself, I
could refer you to the guidance on "Statistical Approaches to
Bioequivalence" which states that those wishing to consider using a
sequential design should consult the agency beforehand. From this I
would assume that the FDA do not specifically preclude doing sequential
studies.
Kind regards,
Alun Bedding
Clinical Pharmacology Scientific and Regulatory Expert Statistics and
Information Sciences
Eli Lilly and Company
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)