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- Lennernäs, Hans, et al.
(författare)
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Oral biopharmaceutics tools - Time for a new initiative - An introduction to the IMI project OrBiTo
- 2014
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Ingår i: European Journal of Pharmaceutical Sciences. - : Elsevier BV. - 0928-0987 .- 1879-0720. ; 57:SI, s. 292-299
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Forskningsöversikt (refereegranskat)abstract
- OrBiTo is a new European project within the IMI programme in the area of oral biopharmaceutics tools that includes world leading scientists from nine European universities, one regulatory agency, one non-profit research organization, four SMEs together with scientists from twelve pharmaceutical companies. The OrBiTo project will address key gaps in our knowledge of gastrointestinal (GI) drug absorption and deliver a framework for rational application of predictive biopharmaceutics tools for oral drug delivery. This will be achieved through novel prospective investigations to define new methodologies as well as refinement of existing tools. Extensive validation of novel and existing biopharmaceutics tools will be performed using active pharmaceutical ingredient (API), formulations and supporting datasets from industry partners. A combination of high quality in vitro or in silico characterizations of API and formulations will be integrated into physiologically based in silica biopharmaceutics models capturing the full complexity of GI drug absorption. This approach gives an unparalleled opportunity to initiate a transformational change in industrial research and development to achieve model-based pharmaceutical product development in accordance with the Quality by Design concept. Benefits include an accelerated and more efficient drug candidate selection, formulation development process, particularly for challenging projects such as low solubility molecules (BCS II and IV), enhanced and modified-release formulations, as well as allowing optimization of clinical product performance for patient benefit. In addition, the tools emerging from OrBiTo are expected to significantly reduce demand for animal experiments in the future as well as reducing the number of human bioequivalence studies required to bridge formulations after manufacturing or composition changes.
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- Szczesniak, T., et al.
(författare)
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A Time Resolution Study of a Continuous Crystal Detector for TOF PET
- 2010
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Ingår i: IEEE Transactions on Nuclear Science. - 0018-9499 .- 1558-1578. ; 57:1, s. 40-47
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Tidskriftsartikel (refereegranskat)abstract
- The majority of current Positron Emission Tomography (PET) systems are based on block-detectors consisting of many scintillating pixels read by a smaller number of photomultipliers (PMTs). An improvement of the time resolution, using a common light readout from a cluster of PMTs, was proposed by Kuhn et al., and tested by us earlier with LSO crystals. This, triggered an idea to design a new PET detector optimized for Time of Flight (TOF) systems, based on continuous crystals. In the present work, we report on optimization of timing with a 20 x 20 x 20 mm(3) LYSO crystal coupled to a 16-channel photomultiplier H8711-200MOD from Hamamatsu. First, measurements were performed of the transit time jitter, the number of photoelectrons and the time resolution using a small 10 x 10 x 5 mm(3) LSO crystal coupled to a H8711-200MOD PMT. Results were compared with data collected from fast timing photomultipliers like Photonis XP1020, XP3060, XP20D0 or Hamamatsu R9800. In the second part of the study, the time resolution measurements and the optimization of the system were made with a continuous LYSO crystal. The final results are discussed in terms of the measured photoelectron number and the requirements for the TOF-PET scanners.
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