Is there a role for microsampling in antibiotic pharmacokinetic studies?

- Introduction Clinical pharmacokinetic studies of antibiotics can establish evidence-based dosing regimens that improve the likelihood of eradicating the pathogen at the site of infection, reduce the potential for selection of resistant pathogens, and minimize harm to the patient. Innovations in small volume sampling (< 50 μL) or ‘microsampling’ may result in less-invasive sample collection, self-sampling and dried storage. Microsampling may open up opportunities in patient groups where sampling is challenging. - Areas Covered The challenges for implementation of microsampling to assure suitability of the results, include: acceptable study design, regulatory agency acceptance, and meeting bioanalytical validation requirements. This manuscript covers various microsampling methods, including dried blood/plasma spots, volumetric absorptive microsampling, capillary microsampling, plasma preparation technologies and solid-phase microextraction. - Expert Opinion The available analytical technology is being underutilized due to a lack of bridging studies and validated bioanalytical methods. These deficiencies represent major impediments to the application of microsampling to antibiotic pharmacokinetic studies. A conceptual framework for the assessment of the suitability of microsampling in clinical pharmacokinetic studies of antibiotics is provided. This model establishes a ‘contingency approach’ with consideration of the antibiotic and the type and location of the patient, as well as the more prescriptive bioanalytical validation protocols.

The good, the bad and the ugly of bone-anchored prostheses: Guideline to assess true clinical outcomes

The aim of this study is to share the key elements of an evaluation framework to determine the true clinical outcomes of bone-anchored prostheses. Scientists, clinicians and policy makers are encouraged to implement their own evaluations relying on the proposed framework using a single database to facilitate reflective practice and, eventually, robust prospective studies.

The hype cycle model: A review and future directions

The hype cycle model traces the evolution of technological innovations as they pass through successive stages pronounced by the peak, disappointment, and recovery of expectations. Since its introduction by Gartner nearly two decades ago, the model has received growing interest from practitioners, and more recently from scholars. Given the model's proclaimed capacity to forecast technological development, an important consideration for organizations in formulating marketing strategies, this paper provides a critical review of the hype cycle model by seeking evidence from Gartner's own technology databases for the manifestation of hype cycles. The results of our empirical work show incongruences connected with the reports of Gartner, which motivates us to consider possible future directions, whereby the notion of hype or hyped dynamics (though not necessarily the hype cycle model itself) can be captured in existing life cycle models through the identification of peak, disappointment, and recovery patterns.