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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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Industry Events |
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Cambridge Healthtech Institute Third Annual SCOPE Summit
7-9 February 2012, Miami Hilton Downtown, Miami FL
The program brings together six conferences under the SCOPE umbrella, which creates an opportunity for idea sharing and cross pollination amongst clinical operations professionals from different groups. Despite a shared exhibit floor where the community can share ideas, each conference remains autonomous and goes deeply into its own set of issues with its expert faculty. Each conference will feature best practice case studies and interactive discussions relevant to clinical operations experts as well as those new to the field.
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News and Press Releases |
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Norwich Expands Capabilities for Phase I-III Clinical Trials
Norwich Clinical Services (NCS), a global provider of clinical research services for the pharmaceutical and biotech industries, today announced a significant expansion to its clinical research capabilities in order to meet growing market demand. Primary to the expansion, NCS unveiled a new clinical facility with capabilities to conduct all aspects of Phase I – III clinical trials including pharmacokinetics in healthy volunteers, bio-availability and bio-equivalence studies, drug metabolism studies, dose proportionality studies and multiple dose studies.
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