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European Biopharmaceutical Review
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| Adaptive clinical research, defined as research
that allows changes in a trial or programme while it
is underway, is increasingly used in pharma as a means of shortening development
timelines and reducing costs – in short, improving efficiency. While there is much
industry discussion of adaptive methods, the range of topics is restricted by an
unduly narrow definition that limits the concept to midcourse changes in study
design. Allowing such design changes is an important and valuable aspect of
adaptive methods that encompasses techniques such as sample size re-estimation,
pruning of treatment arms, alteration of randomisation ratios, Bayesian analyses,
and similar methodologies.
There can be little question about the benefit of such
design-level changes based on their ability to incorporate knowledge as it is
generated and to change how an evaluation proceeds. Two of the simplest
techniques – sample size re-estimation and pruning of treatment arms during
dose-finding – are so valuable that I believe they should be routinely considered in
study planning – a sentiment echoed by the PhRMA working group on adaptive
methodology (1). Failure to at least consider employing these techniques
risks wasting time and money – and often substantial amounts of both. |
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Michael Rosenberg, MD, MPH, is President
and Chief Executive Officer of Health
Decisions, Inc, a private clinical research
company. Michael has been involved with
the strategic design and execution of
pharmaceutical development programmes
for more than 25 years. He currently focuses on the strategic
aspects of development, utilising new technology and
processes to improve the quality and timeliness of decisionmaking
on multiple levels to reduce development time. The
author of more than 150 scientific articles, Michael serves
on numerous advisory groups in business, technology and
medicine. He currently serves as Clinical Professor of
Obstetrics and Gynecology at the School of Medicine and
Adjunct Professor of Epidemiology at the University of
North Carolina. He also remains active in the practice of
emergency medicine. His professional achievements have
been recognised by fellowship in the American College of
Physicians, American College of Preventive Medicine, and
the American College of Epidemiology. Michael received his
undergraduate and medical degrees from the University of
California, US and a Master’s degree in Epidemiology and
Biostatistics from Harvard, US. He was also selected at Ernst
and Young’s Entrepreneur of the Year in the Life Sciences
Division in 2000. |
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Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery
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Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
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