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Open, Inhale, Close

Open, inhale, close has become the Holy Grail of inhaler designers – anything more demanding being considered likely to negatively influence a patient’s desire or ability to correctly use an inhaler device. Therefore, these three steps set in motion the processes needed to defeat the anatomical and physiological barriers in the lungs and nose for delivery of a drug to a local receptor or one in a remote organ. In short, the job of a pharmaceutical aerosol researcher is to overcome the complex chemical, physical, and biological barriers to drug efficacy using a device patients can and will use. The barriers go beyond science; regulations, cost, human nature, and personal experience all play a role in determining if a patient will indeed open, inhale, close. Not even 30-year veterans of Respiratory Drug Delivery (RDD®) meetings can single-handedly accumulate the vast range of knowledge, skills, and experience needed to develop an inhaled product. Pulmonary and nasal product development demands interdisciplinary collaboration and the active involvement of the patient.

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Richard Dalby and Joanne Peart
Co-organisers of RDD 2018
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Richard Dalby
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Joanne Peart
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PCI Clinical Services Announces New Facility Dedicated to Clinical Trial Returns

Philadelphia, USA – October 15, 2018. Leading international pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced the completion of a dedicated Returns Management facility at its Clinical Services Center of Excellence at Bridgend, UK. PCI provides a full service Returns Management service for clients, providing visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study. Returning and reconciling Investigational Medicinal Product (IMP) on completion of a study is a critical part of a Clinical trial and can require complex reverse logistics. Trial outcomes can be impacted if Returns are not processed efficiently and precisely.
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