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European Pharmaceutical Contractor
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One of the most significant factors affecting the potency of medicinal agents is the ability to maintain them in controlled environments. The term 'cold chain' refers to the transportation and storage of drug products that require stable refrigerated conditions. Maintaining the chemical and therapeutic integrity of investigational medicinal products poses special cold chain challenges, since clinical trials require multiple small shipments of trial materials to as many as 300 study sites worldwide. The standard for electronic validation, issued in 21 CFR Part 11, Electronic Records and Signatures, is now part of the globally harmonised protocol for the use of electronic data in the licensing of drug products. Evolving standards and technologies will make e-logistics in temperature-controlled, on-time shipment delivery increasingly challenging. This article discusses the challenges faced during cold chain management and distribution of investigational medicinal products in light of the new e-logistics tools that enable drug sponsors to ensure that drugs used in clinical trials maintain potency from manufacture to clinical site.
Introduction
The term 'cold chain' describes the transportation and storage of products that require stable refrigerated conditions. Such products include vaccines, blood products, insulin, the interferons and most other biological medicines. These agents are vulnerable because they involve proteins which have complex and often delicate structures that fold into secondary and tertiary shapes.
The unfolding of these tertiary configurations causes degradation in activity. After the extensive research devoted to producing a medicine, one of the most significant factors affecting drug potency is the ability to keep the drug in a controlled environment. The World Health Organisation (WHO) has stated that as many as 25 per cent of all vaccine products reach their destination in a degraded state.
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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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