| 1. |
- Åsberg, Dennis, 1988-, et al.
(författare)
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A quality control method enhancement concept : Continual improvement of regulatory approved QC methods
- 2016
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Ingår i: Journal of Pharmaceutical and Biomedical Analysis. - : Elsevier. - 0731-7085 .- 1873-264X. ; 129, s. 273-281
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Tidskriftsartikel (refereegranskat)abstract
- Quality Control methods (QC-methods) play an important role in the overall control strategy for drug manufacturing. However, efficient life-cycle management and continual improvement are hindered due to a variety of post-approval variation legislations across territories and a lack of harmonization of the requirements. As a result, many QC-methods fall behind the technical development. Developing the QC-method in accordance with the Quality by Design guidelines gives the possibility to do continual improvements inside the original Method Operable Design Region (MODR). However, often it is necessary to do changes outside the MODR, e.g. to incorporate new technology that was not available at the time the original method was development. Here, we present a method enhancement concept which allows minor adjustments, within the same measuring principle, outside the original MODR without interaction with regulatory agencies. The feasibility of the concept is illustrated by a case study of a QC-method based on HPLC, assumed to be developed before the introduction of UHPLC, where the switch from HPLC to UHPLC is necessary as a continual improvement strategy. The concept relies on the assumption that the System Suitability Test (SST) and failure modes are relevant for other conditions outside the MODR as well when the same measuring principle is used. It follows that it should be possible to move outside the MODR as long as the SST has passed. All minor modifications of the original, approved QC-method must be re-validated according to a template given in the original submission and a statistical equivalence should be shown between the original and modified QC-methods. To summarize, revalidation is handled within the pharmaceutical quality control system according to internal change control procedures, but without interaction with regulating agencies.
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| 2. |
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| 3. |
- Albin, Björn, et al.
(författare)
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Situation for carers of the elderly in Sweden
- 2008
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Ingår i: Studies of Community Welfare: Chiiki Fukushi Kenkyu. - : Nihon Seimei Saiseikai Osaka. ; :38, s. 72-83
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Tidskriftsartikel (refereegranskat)abstract
- In most societies informal care of the elderly (often given by a relative) plays an important role, this article describes the situation and support for carers that exist in Sweden. The description is partly based on the results from the evaluation of a project (“Anhörig 300”) aimed to develop support for carers in the County of Kronoberg as well as from information and documents. Four different typical situations for carers are identified and is an indication of how different situations for carers can be. In the future the support for carers must be paid attention to and further developed. The National Development Plan for the Nursing and Care for elderly in Sweden suggest increased support for carers as a supplement to the public sector elderly care. It is important to involve voluntary organizations to break isolation and loneliness among carers.
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| 4. |
- Andersson, Peter, et al.
(författare)
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Active Matrix Displays Based on All-Organic Electrochemical Smart Pixels Printed on Paper
- 2002
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Ingår i: Advanced Materials. - Weinheim, Germany : Wiley-VCH Verlagsgesellschaft. - 0935-9648 .- 1521-4095. ; 14:20, s. 1460-1464
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Tidskriftsartikel (refereegranskat)abstract
- An organic electronic paper display technology (see Figure and also inside front cover) is presented. The electrochromic display cell together with the addressing electrochemical transistor form simple smart pixels that are included in matrix displays, which are achieved on coated cellulose-based paper using printing techniques. The ion-electronic technology presented offers an opportunity to extend existing use of ordinary paper.
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| 5. |
- Andersson, Peter, et al.
(författare)
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Organic Electrochemical Smart Pixels
- 2003
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Ingår i: Materials Research Society Symposium Proceedings. ; , s. D6.6-
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Konferensbidrag (refereegranskat)
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| 6. |
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| 7. |
- Baravdish, George, et al.
(författare)
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Damped second order flow applied to image denoising
- 2019
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Ingår i: IMA Journal of Applied Mathematics. - : Oxford University Press. - 0272-4960 .- 1464-3634. ; 84:6, s. 1082-1111
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Tidskriftsartikel (refereegranskat)abstract
- In this paper, we introduce a new image denoising model: the damped flow (DF), which is a second order nonlinear evolution equation associated with a class of energy functionals of an image. The existence, uniqueness and regularization property of DF are proven. For the numerical implementation, based on the Störmer–Verlet method, a discrete DF, SV-DDF, is developed. The convergence of SV-DDF is studied as well. Several numerical experiments, as well as a comparison with other methods, are provided to demonstrate the efficiency of SV-DDF.
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| 8. |
- Baravdish, George, et al.
(författare)
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Extension of p-Laplace Operator for Image Denoising
- 2016
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Ingår i: 27th IFIP TC 7 Conference, CSMO 2015, Sophia Antipolis, France, June 29 - July 3, 2015, Revised Selected Papers. - Cham : Springer. - 9783319557946 - 9783319557953 ; , s. 107-116, s. 107-116
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Bokkapitel (refereegranskat)abstract
- In this work we introduce a novel operator $$\displaystyle \varDelta _(p,q)$$ as an extended family of operators that generalize the p-Laplace operator. The operator is derived with an emphasis on image processing applications, and particularly, with a focus on image denoising applications. We propose a non-linear transition function, coupling p and q, which yields a non-linear filtering scheme analogous to adaptive spatially dependent total variation and linear filtering. Well-posedness of the final parabolic PDE is established via pertubation theory and connection to classical results in functional analysis. Numerical results demonstrates the applicability of the novel operator $$\displaystyle \varDelta _(p,q)$$ .
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| 9. |
- Baravdish, George, 1964-, et al.
(författare)
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Generalizations of p-Laplace operator for image enhancement : Part 2
- 2020
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Ingår i: Communications on Pure and Applied Analysis. - Springfield, MO, United States : American Institute of Mathematical Sciences. - 1534-0392 .- 1553-5258. ; 19:7, s. 3477-3500
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Tidskriftsartikel (refereegranskat)abstract
- We have in a previous study introduced a novel elliptic operator Delta((p,q))u = vertical bar del u vertical bar(q) Delta(1)u + (p - 1) vertical bar del u vertical bar(p-2)Delta(infinity) u, p >= 1, q >= 0, as a generalization of the p-Laplace operator. In this paper, we establish the well-posedness of the parabolic equation u(t) =vertical bar del u vertical bar(1-q) Delta((1+q,q)), where q = q(vertical bar del u vertical bar) is continuous and has range in [0, 1], in the framework of viscosity solutions. We prove the consistency and convergence of the numerical scheme of finite differences of this parabolic equation. Numerical simulations shows the advantage of this operator applied to image enhancement.
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| 10. |
- Baravdish, George, et al.
(författare)
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Identifying a response parameter in a model of brain tumour evolution under therapy
- 2023
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Ingår i: IMA Journal of Applied Mathematics. - : Oxford University Press. - 0272-4960 .- 1464-3634. ; 88:2, s. 378-404
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Tidskriftsartikel (refereegranskat)abstract
- A nonlinear conjugate gradient method is derived for the inverse problem of identifying a treatment parameter in a nonlinear model of reaction-diffusion type corresponding to the evolution of brain tumours under therapy. The treatment parameter is reconstructed from additional information about the tumour taken at a fixed instance of time. Well-posedness of the direct problems used in the iterative method is outlined as well as uniqueness of a solution to the inverse problem. Moreover, the parameter identification is recasted as the minimization of a Tikhonov type functional and the existence of a minimizer to this functional is shown. Finite-difference discretization of the space and time derivatives are employed for the numerical implementation. Numerical simulations on full 3D brain data are included showing that information about a spacewise-dependent treatment parameter can be recovered in a stable way.
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