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| home > epc > spring 2002 > ensuring adequate temperature controlled distribution - regulations, recommendations and technology |
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 PUBLICATIONS |
European Pharmaceutical Contractor
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New Pharmaceutical Challenges
Temperature controlled deliveries of pharmaceuticals and samples are increasingly common. Five years ago the majority of flu vaccines distributed were not temperature controlled. Today, 65 per cent are delivered through the cold chain using packaging and monitoring advances based on the latest recommendations from regulatory bodies. Collaboration, particularly in research, means sensitive substances need to be shared quickly between partners. However, a number of regulations govern such materials, especially in clinical trials. These regulations are continuing to evolve, but packaging and monitoring technology exists which meets and even anticipates the legal regulations. The following industry issues have led to the need for more advanced temperature controlled packaging, monitoring and supply chains:
Mega-mergers and increasing collaboration - Efforts to achieve a critical mass
in R&D and reduce production and marketing costs have led to companies working
alongside former competitors. The industry as a whole faces greater competition and
more integration with a range of business partners.
Falling R&D productivity and shortening patent times - R&D has become a race
against time where delays can be costly. There are few rewards for second place.
In 2000, 13 of the top 100 drugs sold were not patented. By 2005, 53 of the top 100
drugs will be off-patent when they go to market.
More demanding consumers and end users - Greater availability of information due
to initiatives such as direct-to-consumer marketing has led to more consumer choice and
price competition. This in turn has increased the need for direct distribution to some end
users or more complicated supply chains.
Regulatory changes that demand greater control and accountability.
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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.
More info >> |
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News and Press Releases |
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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...
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