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Case study

Development of a Novel Blinding Methodology for a Market Leading Dry-Powder Inhaler (DPI)

A mid-sized pharmaceutical company was planning to enter a phase III trial with a promising new treatment for asthma and COPD. To eliminate bias, the client’s clinical team had designed a double-blind clinical trial. While manufacturing active and placebo forms of their own product was possible, developing a method to blind their product against the visually different active comparator was more of a challenge. The company approached Almac to help solve this problem. Almac had never handled this product before, and within a limited time frame we had to develop and validate a cost effective, reliable and reproducible blinding method capable of handling the volumes required to support the client’s planned clinical trial demand.

Innovation is one of Almac’s core values. Almac’s unique inhaler blinding services provide a perfect illustration of this. While Almac has already developed and validated clinical blinding techniques for most leading inhalers, continued launches of new inhalers mean we consistently face new challenges in this specialized area of clinical trial supplies.

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