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Destiny’s SA trial shows fast acting antibiotic too quick for disease resistance

5 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The two-stage clinical trial studied the safety, tolerability, and efficacy of intra-nasally applied exeporfinium chloride gels. Part 1 yielded safety data in eight volunteers and allowed progression to Part 2 in 48 healthy volunteers with colonised nasal Staphylococcus aureus (SA) bacteria. Part 2 was double-blinded, placebo controlled, and investigated two…

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Environmental Monitoring In-Depth Focus 2016

24 August 2016 | By European Pharmaceutical Review

In this Environmental Monitoring In-Depth Focus: Bacterial endotoxin contamination and testing limits in ophthalmics; The basics of environmental monitoring in aseptic units; Environmental Monitoring Roundtable...

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Approaches in subcutaneous delivery of monoclonal antibodies

24 August 2016 | By , , ,

Currently, subcutaneous delivery of therapeutic proteins is a fast-growing field, especially for such established modalities as monoclonal antibodies, which require large quantities of drug to be administrated. Different approaches, including high protein concentration, speciality formulations and drug delivery matrices, as well as devices enabling a more rapid administration of larger…

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Current activities of the USP general chapters

24 August 2016 | By

From a microbiological perspective, pharmaceutical products fall into two categories – nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or…