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European Pharmaceutical Contractor
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In the European Union, the paediatric population (0-16 years old) represents about 75 million people, a fifth of the total population. Although this population may appear relatively large, the majority of medicines are still only developed and assessed for use in adult populations. The absence of suitable authorised medicinal products to treat diseases in children has been an issue of concern for some time.
This is mainly a result of the failure of pharmaceutical companies to perform the necessary tests and trials to adapt medicinal products to the needs of children. It is estimated that over two thirds of patients admitted to paediatric wards in European hospitals received drugs prescribed in an unlicensed or off-label manner, not having been specifically evaluated for use in children. Consequently it leads to risks of inefficacy and/or adverse effects.
Pharmaceutical companies have traditionally been reluctant to invest in developing specific treatments or adapting existing medicines to meet the needs of the paediatric population, mainly because the market is small and therefore of lower priority to them - and the risks associated with paediatric treatments are generally higher (for example, need for long-term follow-up of adverse effects). In addition, the pharmaceutical industry tends not to develop specific paediatric formulations.
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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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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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