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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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Charles River Laboratories Expands Services for Early Discovery Screening

WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today announced the expansion of its service capabilities in early discovery screening. Charles River is the first contract research organization to offer clients access to Apricot Designs' Dual Arm (ADDA) system for high-throughput absorption, distribution, metabolism, and excretion (HT-ADME) to identify potential lead compounds in North America and Europe. Additionally, the Company has geographically expanded its pharmacokinetic (PK) capabilities at sites central to major pharmaceutical and biotechnology hubs.
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With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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SMi presents the 13th Conference on ADMET

9-10 July 2018, Holiday Inn Kensington Forum, London, UK

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