|
 |
European Pharmaceutical Contractor
|
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.
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
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.
|
|
|
|
|
|
 |
Industry Events |
 |
4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
|
 |
News and Press Releases |
 |
MipTec, October 14 – 16, 2008, Switzerland
MipTec about to take off by joining forces between Life Sciences Week, ALL-SystemsX.ch-Day, & Jobvector.com
More info >> |
|
 |
