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Discovery & Development Drug Delivery

Dosing For Compliance

Healthcare professionals typically make a diagnosis and then match the patient’s condition to a prescription drug that has been subject to controlled, randomized clinical trials. But in the “chaotic world of medical practice” – to use the words of Sharfstein and Kesselheim (1) – the therapeutic outcomes observed in clinical trials are not always transferable to the real world. Indeed, some medicines – although designed to be effective – simply aren’t practical for real-life patients; for example, the dosage form may not have been fully considered. What if the tablet or capsule is too large to swallow or the patient simply has too many separate medicines to deal with?

Those of us involved in developing medicines must start to focus not only on the disease and clinical parameters, but also on real-world aspects, such as how each patient experiences his or her disease, lives with the symptoms, and sometimes balances them against other ailments. Those who have cared for an elderly relative will be able to relate to how challenging it can be for them – and for us – to keep up with a complex daily medication schedule. Often, the regimen may include several different drugs, all in different dosage forms. Each pill will have its own shape, color, size and packaging designed to help us to tell them apart, but actually this diversity can add to the complexity. Further, the medicines may need to be taken before or after meals, split rather than swallowed whole, or administered in the morning or at night. And frustratingly, some medicines packaged in medicine vials or blister packs can be difficult to open. While these medicines are “effective” by clinical trial standards, they are not always sufficiently tailored to meet patient needs, which may affect other important factors, such as patient compliance.

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About the Author

Sven Stegemann

Head of Global Scientific Business Development at ACG

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