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Pharmaceutical Manufacturing and Packing Sourcer
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When comparing a dry powder inhaler (DPI) project to many other product developments, one is struck by the time it takes to get to market. Even when the drug formulation is well-understood, programmes regularly take in excess of eight years to reach the customer. Yet the basic design process of envisage, explore, evolve and embody is well understood and unchanged, so what is holding us up? A close inspection of past programmes shows that it is not these activities that are hindering the process - rather the repeated iterations, later in the programme, that arise from a changing specification and technical problems identified too late in the process.
The heart of the problem is that a DPI is an immensely complicated system. Even the simplest devices rely on a complex interaction of variables including patient inhalation, drug, static, humidity and material. Small variations in these variables can produce significant changes in the performance of the device. The first step to addressing this is to have a clear view of what the team is trying to achieve.
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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 Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
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