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					DEMOGRAPHIC CONSIDERATIONS IN BIOEQUIVALENCE STUDIES.
              S. Lamouche, Ph.D., K. Boulanger, M.Sc., E. Shink, Ph.D., F. Trabelsi, Ph.D., M. Tanguay, Ph.D.


SFBC Anapharm
PURPOSE: The objective of bioequivalence (BE) studies is to evaluate whether two products are equivalent in rate and
extent of absorption. Attempts are made to diminish or tightly control any confounding variables in order to achieve this
objective. It is sometimes argued that enrolling a more homogeneous population would reduce the intra-subject coefficients
of variability (ISCV) of pharmacokinetics parameters, thus requiring fewer subjects. The purpose of this study was to
conduct a retrospective analysis on BE studies conducted at SFBC Anapharm to examine the impact of demographic factors
on the ISCV. METHODS: 75 two-way cross-over BE studies involving anti-hypertensives and anti-depressants were
included in this analysis. These therapeutic areas were chosen as they offered the largest pool of study with the least
restrictive inclusion criteria for the initial study population. For each individual study, the ISCV was recalculated considering
a more homogenous population where subjects satisfied stringent inclusion criteria for the factor being investigated:
   Factor                               Included                              Excluded
   Gender                               Men only                              Women
   Age                                  18 to 55 years                        56 years and older
   Ethnicity                            Caucasian only                        All but Caucasians
   Body mass index (BMI)             ≥     19 and 24.9 kg/m2
                                               ≤                              < 19 and > 25 kg/m2
   Smoking                              Non-smokers                           Smokers
The ISCV with and without the subset of the original population being investigated were compared by parametric (Student
Paired T-Test) and non-parametric (Signed Rank test) tests. RESULTS: Overall, the majority of studies showed a reduced
ISCV when including a more homogeneous population in terms of Gender (p = 0.0009), Age (p = 0.0273), and Smoking (p =
0.0164). For anti-hypertensives, only Gender (p = 0.0004) and Age (p = 0.038) had an impact whilst for anti-depressants,
Smoking was the only significant factor (p = 0.0310). CONCLUSIONS: Restricting study population in terms of Gender,
Age, and Smoking could be associated with a decrease in ISCV, although this was not observed for all drugs investigated.
However, being more stringent for BMI and Ethnicity did not result in changes in ISCV. These results may be useful in
designing future BE studies with special emphasis on demographic factors.

				
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posted:1/9/2009
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