|
 |
European Pharmaceutical Contractor
|
| Boaz Mendzelevski, a Cardiac Safety Consultant, examines drug-induced repolarisation abnormalities and proarrhythmia with regard to improving cardiovascular safety in drug development
Cardiac safety is a relatively new field in drug development clinical research. It first emerged as a regulatory focus after the high-profile withdrawals of drugs such as terfenadine and cisapride in the 1990s, and became synonymous with drug-induced QT prolongation and its associated cardiac arrhythmia – torsades de pointes (TdP). Recent regulatory guidance, most notably ICH-E14, brought cardiac safety into the forefront of regulatory medicine. Since 2000, cardiac safety became the primary reason for drug withdrawals and non-approval of new drugs. Early detection of potential QT prolongation and TdP liability is now an essential component of the drug development paradigm.
Most recently, the scope of cardiac safety drug development has expanded and now covers three major areas of potential drug-induced cardiac toxicity: cardiac repolarisation, or drug-induced QT prolongation leading to cardiac arrhythmia; vascular thrombosis leading to myocardial ischemia and infarction; and direct myocardial toxicity leading to loss of cardiac tissue and heart failure. This article will provide an up-to-date overview of the evolving field of drug cardiac safety and the science behind drug-induced cardiotoxicity, current regulatory requirements and drug development strategies to improve management of drug cardiac safety and bring safer medicines to market. |
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 >> |
|
 |
