|
 |
| home > epc > summer 2003 > abnormal laboratory findings in healthy subjects: biochemical tests in clinical research |
|
|
 PUBLICATIONS |
European Pharmaceutical Contractor
|
A central function of the chemical pathology or clinical chemistry laboratory is to provide biochemical information for the management of patients and/or trial subjects. Such information will be of value only if it is accurate and relevant, and if its significance is appreciated by the clinician so it can be used appropriately to guide clinical decision-making. Biochemical tests are used throughout diagnosis, prognosis, monitoring and screening of trial subjects (Figure 1).
Critical (Panic) Values
The concept of critical values was introduced by Lundberg in 1972 and incorporated into accepted standards of good laboratory practice shortly thereafter. However, critical values have received little attention in indexed medical literature since a critical value is described as "a pathophysiological state at such variance with normal as to be life-threatening unless something is done promptly and for which some corrective action could be taken". The critical values list should deliberately be limited to a crucial selection of tests with undeniably critical limits:
Critical values should be identified by strictly semantic interpretation of the critical limits (for example using a glucose result of 15mmol/L is a critical value, but a result of 14.9mmol/L is not)
A critical value should be reported only if the condition of the sample is satisfactory, for example free of gross lipemia and hemolysis
No laboratory result, including a critical value, should be reported unless its validity has been established. Therefore, reassay, if required by laboratory protocol, should precede critical value notification
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
By Johann Terblanchй, Senior Director and Head, Clinical Division at Farmovs-Parexel
After graduating from the University of Pretoria, Johann Terblanchй spent 15 years as a Family Physician in General Practice, which included surgery, obstetrics, gynaecology, anaesthetics and psychiatry. He joined the Department of Pharmacology at the University of the Free State as Chief Medical Officer in 1994, starting his research career in 1995 as Director, Clinical Services at the FARMOVS Research Centre for Clinical Pharmacology and Drug Development.
In January 2001 he became Senior Director and Head, Clinical Division at FARMOVS-PAREXEL Clinical Research Organisation. He is involved in trials at FARMOVS-PAREXEL Clinical Division as Principal Investigator, which includes approximately 50 Phase I trials per year, as well as about 25 Phase II and III clinical studies and has published six articles in peer-reviewed journals.
|
|
|
|
|
|
 |
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 >> |
|
 |
