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European Pharmaceutical Contractor
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The role of the European as well as the American guidance to the industry is to standardise the design and clinical performance of bioequivalence studies. However, in practice there are some issues and problems that are dealt with in various ways by different CROs, and without any guidelines from the regulatory authorities. These practical problems will be discussed in this article, together with suggestions to overcome these grey areas.
The practical issues that need to be addressed and harmonised across CROs globally, include the following:
The handling of concentrations below the limit of quantification
(BLQ) of the analytical method. These values influence the
calculation of pharmacokinetic variables and are handled in
different ways by CROs.
Calculation of descriptive statistics of concentrations
that include BLQ values.
The use of the actual sampling intervals in the calculations
of the pharmacokinetic variables.
Interpretation of mean graphs. It is common practice for
authors to make use of mean graphs to illustrate the information
obtained in research projects. These graphs illustrate the
observed data, and can be very useful in discussions.
However, in certain instances mean graphs can give a
misleading picture of the individual results, which may lead
to misinterpretation of the data.
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By Dr Linda Potgieter, Senior Director at FARMOVS-PAREXEL, South Africa
Dr Linda Potgieter is a Senior Director at FARMOVS-PAREXEL in Bloemfontein, South Africa. She joined the organisation in 1978 and founded the Biometry Division. This division is involved in statistical analyses for Phase I to III clinical studies, bioequivalence studies, food and drug interaction studies, drug-drug interaction studies, first in man studies, glucose clamp studies, efficacy and safety studies, as well as tolerability studies.
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