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European Pharmaceutical Contractor
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| The idiosyncracy of dermatology clinical trials poses key challenges to the pharmaceutical industry that require an imaginative response; Theresa Callaghan of proDERM reports
The therapeutic advances observed in dermatology today are based on the outcomes of carefully controlled clinical trials. With the development of novel therapies to treat a variety of skin diseases such as immunomodulators, retinoids, monoclonal antibodies, cytokines and so on, and the advances made through current scientific interest in the treatment of skin cancer and the consequences of age manifested in the skin, dermatology has developed its own unique position, not only within medicine, but also in clinical trials.
The most credible basis now widely accepted for evaluating both safety and efficacy of new dermatological drugs is data obtained from randomised controlled clinical trials. To prevent bias many Phase II and most Phase III drug trials are designed to be randomised, double-blind and placebo-controlled. The most commonly performed clinical trials evaluate new drugs, medical devices, or other interventions on patients in strictly controlled settings and are required for regulatory authority approval of new therapies (in the US, the Food and Drug Administration (FDA); in Canada, Health Canada; in the EU, the European Medicines Agency; in Japan, the Ministry of Health, Labor and Welfare). Although the conduct of clinical trials is becoming increasingly complex, due to technological advances and mounting regulatory and economic pressures, the opportunities within dermatological clinical trials, and moreover those conducted within dedicated dermatological clinical research organisations, are unique. |
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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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