Proposed Therapeutic Strategies for Cancer Using New Methods and Novel Approaches

Aug 6, 2018

In the history of cancer treatment, the main idea was initially to have one approach, using one method or treatment agent. After this concept, the approach became a bit more multilevel and then the treatment was considered under the concept of surgery, radiation or chemotherapy. Unfortunately, despite this change in the concept of the treatment, the clinical outcome is still poor since the overall survival or response rate hasn’t changed dramatically. This article by Ioannis Papasotiriou from RGCC will try to propose possible options that may be added to the present concept or become standalone alternatives to cancer treatment based ...

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Simplifying NMR for Fluorine-containing Samples

Aug 6, 2018

Currently, more than 200 marketed medicines, and approximately one-third of the most successful – so called ‘blockbuster’ – drugs contain fluorine atoms in their structure. Fluorine-containing compounds span a wide variety of therapeutic classes: anti-cancer drugs, antifungal agents and NSAIDs (non-steroidal anti-inflammatory drugs), for example. Fluorine is also now commonly found in illicit and illegal drugs, including synthetic cannabinoids and psychedelic phenethylamines. Michael H. Frey and Ron Crouch from JEOL USA explain how we can use NMR to distinguish readily between these legitimate and illegitimate substances. ...

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Patient Safety & Elemental Impurities ICH Q3D

Aug 6, 2018

From 1 January 2018, the European Pharmacopeia (EP) and the United States Pharmacopeia (USP) have replaced the old methods for testing of heavy metals (USP <231> and Ph.Eur. 2.4.8) in raw materials with a new harmonised guideline “ICH Q3D”. Drug product manufacturers are responsible for providing a risk-based assessment of the elemental impurities, justifying that the contents for each of the 24 elements are below the exposure limit as described in ICH Q3D. Rie Romme Rasmussen from Eurofins explains that the elemental impurity level and variability must be established by validated analytical methods specific for each matrix to avoid biased ...

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Understanding the Challenges in Designing and Executing Clinical Trials for Screening Tests

Aug 6, 2018

Clinical trials for screening tests of a drug candidate take place at the very early clinical development, i.e. Phase I clinical study. The aim of such studies is to assess drug candidate safety, its actual fate in human body after administration (PK/PD data, metabolite identification, mechanism of elimination and excretion, etc.), its tolerance threshold (dose escalating) and its adverse effects. All of those make Phase I clinical trials crucial to the drug development process; Isabelle Decorte from Synerlab proposes that designing and executing such clinical studies needs much preparation and planning. ...

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Digital Devices in Clinical Trials

Aug 6, 2018

Most pharmaceutical companies are investigating how digital devices can be utilised in clinical trials to improve the data foundation, and potentially assist in securing a faster time to market and improving patient retention. One common challenge stands out: how do you create a setup robust enough to allow you to include the output data as evidence? This article by Rune Bergendorff from NNIT discusses the common challenges faced and, based on network consultations with a group of pharmaceutical companies, it seeks to identify a viable path forward. ...

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