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| home > pmps > summer 2003 > temperature-controlled distribution in the health care industry - a field of growing importance |
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Pharmaceutical Manufacturing and Packing Sourcer
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According to John Taylor, a representative of the Quality Systems Division of the Medicines and Healthcare products Regulatory Agency (MHRA), around one quarter of all significant failures to comply with GDP are due to inadequate control and/or monitoring of the storage and transportation temperatures. While temperature-controlled distribution has always been important to the health care industry, the current biotechnological revolution has further increased the need for protection of thermally unstable products. At the same time, the health care supply chain is becoming more complex, with smaller and more frequent shipments, further increasing the demand on solutions.
Temperature-Sensitive Products are Growing in Importance
Although some observers believe that the rate of growth for the global health care industry will slow down considerably over the next few years, at the same time they agree that some segments will sustain or increase growth rates. One such segment, which is growing faster than the industry in general, is the biotechnology segment. Of the more than 130 biotechnology drugs and vaccines approved by the US Food and Drug Administration (FDA), 70 per cent were approved in the last six years according to the Biotechnology Industry Organisation, 2002. At the same time there are more than 350 biotech drug products and vaccines currently in clinical trials targeting more than 200 diseases according to the Biotechnology Industry Organisation, 2002. Many of these biotechnology drugs are temperature-sensitive. It is estimated that the temperature-sensitive segment is growing at a rate of about 15 per cent per year.
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Industry Events |
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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.
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