|
 |
| home > epc > spring 2003 > how to include genetic analysis in clinical trials |
|
|
 PUBLICATIONS |
European Pharmaceutical Contractor
|
The demand for genetic analysis in clinical trials is increasing. This is partly due to the growing realisation that understanding the genetic variation within a clinical trial population can improve the design, safety and outcome of the trial. A second major driver is the encouragement that the regulatory authorities, in particular the FDA, are giving to the inclusion of a pharmacogenomic element. For the pharmaceutical company or CRO wishing to incorporate a genetic analysis component there are now a number of service providers who have both the technical ability and appropriate quality systems to provide clinical trial grade genotyping.
Deciphering the complete human genome sequence has been one of man's greatest scientific achievements and will create a data set of the full complement of human genes. Variation within these genes is responsible for all of our individuality, including our likelihood of developing a disease and also response to therapy. It is hardly surprising then that the pharmaceutical industry is looking at ways to use this knowledge, not only to discover new drugs, but also to improve the way that these drugs are developed and used.
At present the majority of genetic analysis performed on behalf of pharmaceutical companies is to assist in the identification and validation of new targets for drug discovery. This is now changing and genetic testing is becoming increasingly common as part of the clinical trial process as scientists and clinicians begin to understand the benefits it can bring.
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
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 |
 |
Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
More info >> |
|
 |
