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European Pharmaceutical Contractor
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The term 'validated assay' is frequently used to justify the veracity of analytical data. The guarantee that this terminology provides depends upon the nature and extent of validation, which in turn is dependent upon the application of the data. Is the data to be used for definitive pharmacokinetics/pharmacodynamics? Is it to be used as a clinical indicator of a diseased state, or for identifying/stratifying different disease populations and/or the likelihood of response to different therapies? The different validation criteria are discussed with relevance to the application of different assays.
Validating Analytical Methods
The term validation is widely used and is often misunderstood as it can provide a false sense of security. Generally it applies to the requirement to characterise or evaluate the performance of an analytical method with respect to defining its response function, such as a standard curve. The parameters of precision, accuracy, sensitivity and selectivity (specificity) are frequently referred to as the PASS criteria. In addition the stability of the analyte, although not a characteristic of the assay, is certainly a function of the analyte and the method used, and should be determined as soon as possible.
Validation is considered in some cases to be a one-occasion event. However, this is not so and additional validation may be needed in response to a number of changes. For example, this can be caused by changes in sample collection conditions, dietary issues, health status, sex, sampling times (diurnal variations), method material, analyst, anticoagulants and so on. Usually performance characteristics are set to define the proposed application.
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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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