The measurement of inhalation flow profiles of subjects inhaling through dry powder inhalers (DPIs) has been coming more and more into focus lately and is, for instance, currently requested by the EMA and FDA as part of the in-vivo device characterization process. In order to thoroughly understand the technical and device specific aspects during inhalation, a comparison of flow profile measurements is considered necessary.
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Several issues must be considered when planning the preclinical development program of a novel investigational compound. Among them are the nature of the target, the mode of action, the choice of suitable animal models, the identification of pharmacologically effective doses levels, the design of preclinical proof-of-concept studies, and the adequate design of toxicology studies in at least two animal species that are predictive for the situation in humans, et cetera. But there are even more important aspects that are related to regulatory affairs issues. The early elaboration of a good integrated project plan offers the opportunity to identify the critical path, and an efficient project management can streamline the developmental period. This paper focusses on three major items that should be considered to manage a smooth transition from pre-clinical to clinical research with intent to commence the clinical development program in good time and have it adequately designed to make sure the planning targets will be met.
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Diabetes is a serious chronic disease and one of the largest global health emergencies of the 21st century. Due to the risks associated with a raised blood glucose level, each type of diabetes can lead to serious complications in the heart, blood vessels, kidneys, eyes and nerves. The number of cases has steadily increased over the past few decades and has imposed a large economic burden on the global health care system. Thus, there is only one conclusion - it is important to halt the rise of diabetes and improve lives of those affected by conducting research in this area. This paper details the key points to consider when conducting a study on diabetes patients.
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At the moment, it is expected that EU Regulation No. 536/2014 on clinical trials on medicinal products for human use will repeal Directive 2001/20/EC relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use in 2019. The new EU regulation will introduce novel concepts and requirements, such as risk proportionate approaches in clinical trials, the provision of layperson summaries of clinical trial results, and the definition of Auxiliary Medicinal Products (formerly referred to as Non-Investigational Medicinal Products) in clinical trials. The European clinical trial environment will benefit from the EU Regulation No. 536/2014 in several ways. The most important improvements and advantages of the new regulation seem to be the harmonization in study application procedures and the partial mutual recognition of review procedures across the Member States.
This article provides an overview of the regulation to come in relation to the EU directive to be repealed and presents a detailed outline of the changes and their implications.