| 1. |
- Govender, Rydvikha, 1989, et al.
(författare)
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Therapy for the individual: Towards patient integration into the manufacturing and provision of pharmaceuticals
- 2020
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Ingår i: European Journal of Pharmaceutics and Biopharmaceutics. - : Elsevier BV. - 1873-3441 .- 0939-6411. ; 149, s. 58-76
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Forskningsöversikt (refereegranskat)abstract
- Individualized therapy with pharmaceutical products aims to elicit predictable and optimized treatment responses from specific patients. Doing so requires production platforms and technology capable of tailoring products to individual patient needs. However, despite recent manufacturing innovations and key technologies on the rise, e.g. continuous manufacturing and additive manufacturing (3D printing), the prevailing production paradigm employed in the pharmaceutical industry is mass production. Although mass production is efficient and cost-effective, it is typically based on a ‘one-size-fits-all’ product concept and lacks the flexibility and agility required to fully meet the needs of the individual patient. Indeed, we present data that confirm a suspected major imbalance between the recent medical evolution underpinning personalized/precision medicine and the recent advances in the associated manufacturing technologies. In this context we target the needs of the individual as a main driver for pharmaceutical products which support individualized therapy. We particularly address that a wider integration of critical patient dimensions into the manufacture and provision of pharmaceutical products is pivotal for enabling a patient-centric and efficient mass customization-based production paradigm. Here, we present a critical review of the area and its inherent challenges which aims to clarify key design requirements for establishing mass customization opportunities. Through primary sources of scientific information for individualized therapies, patient needs are captured, analysed, and conceptualized. This summarized set of key drivers provides the basis for a proposed patient-centric framework of requirements for use in design of product and production platforms for mass customization. The extent to which emerging pharmaceutical manufacturing technologies satisfy key individual patient needs is explored through a high-level assessment against the proposed patient-centric framework, with special attention paid to oral dosage forms. Altogether this holistic review and position paper, with its constituent steps, reveals major gaps in the evolution of Product-Process-Production approaches and solutions required for producing affordable individualized/personalized pharmaceuticals that respond to the needs and demands of the individual patient. Lastly, in a brief commentary and outlook, we suggest key research directions for closing gaps and addressing manufacturing technology challenges. We also articulate the importance of tackling them in a holistic, integrated way, together with challenges in product individualization and personalization.
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| 2. |
- Holm, Patur M., et al.
(författare)
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The Effects of Different Management Strategies or Rehabilitation Approaches on Knee Joint Structural and Molecular Biomarkers Following Traumatic Knee Injury : A Systematic Review of Randomized Controlled Trials for the OPTIKNEE Consensus
- 2023
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Ingår i: Journal of Orthopaedic and Sports Physical Therapy. - : Journal of Orthopaedic & Sports Physical Therapy (JOSPT). - 0190-6011 .- 1938-1344. ; 53:4, s. 172-193
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Forskningsöversikt (refereegranskat)abstract
- OBJECTIVE: To summarize the effectiveness of management strategies and rehabilitation approaches for knee joint structural and molecular biomarker outcomes following anterior cruciate ligament (ACL) and/or meniscal tear. DESIGN: Intervention systematic review. LITERATURE SEARCH: We searched the MEDLINE, Embase, CINAHL, CENTRAL, and SPORTDiscus databases from their inception up to November 3, 2021. STUDY SELECTION CRITERIA: We included randomized controlled trials (RCTs) investigating the effectiveness of management strategies or rehabilitation approaches for structural/molecular biomarkers of knee joint health following ACL and/or meniscal tear. DATA SYNTHESIS: We included 5 RCTs (9 papers) with primary ACL tear (n = 365). Two RCTs compared initial management strategies (rehabilitation plus early vs optional delayed ACL surgery), reporting on structural biomarkers (radiographic osteoarthritis, cartilage thickness, meniscal damage) in 5 papers and molecular biomarkers (inflammation, cartilage turnover) in 1 paper. Three RCTs compared different post-ACL reconstruction (ACLR) rehabilitation approaches (high vs low intensity plyometric exercises, accelerated vs nonaccelerated rehabilitation, continuous passive vs active motion), reporting on structural biomarkers (joint space narrowing) in 1 paper and molecular biomarkers (inflammation, cartilage turnover) in 2 papers. RESULTS: There were no differences in structural or molecular biomarkers between post-ACLR rehabilitation approaches. One RCT comparing initial management strategies demonstrated that rehabilitation plus early ACLR was associated with greater patellofemoral cartilage thinning, elevated inflammatory cytokine response, and reduced incidence of medial meniscal damage over 5 years compared to rehabilitation with no/delayed ACLR. CONCLUSION: Very low-certainty evidence suggests that different initial management strategies (rehabilitation plus early vs optional delayed ACL surgery) but not postoperative rehabilitation approaches may influence the incidence of meniscal damage, patellofemoral cartilage loss and cytokine concentrations over 5 years post-ACL tear.
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| 3. |
- Larsson, Staffan, et al.
(författare)
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Confronting globalisation : Learning from intercontinental collaboration
- 2005
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Ingår i: Innovations in Education & Teaching International. - : Informa UK Limited. - 1470-3297 .- 1470-3300. ; 42:1, s. 61-71
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Forskningsöversikt (refereegranskat)abstract
- Higher education institutions are responding to globalisation in various ways. This study describes and analyses challenges encountered in a recent case of global collaboration between four universities on different continents in developing a web-based master's program. The key issue was how to develop programs in a way that is fair for the different countries involved. The focus of the paper is on tensions between local and national contexts, rules and resources and the creation of a common global program. 'Agency', 'structure' and 'frame factor' are used as analytical concepts to help understand the dynamics of the collaboration and the character of the program.
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| 4. |
- Lundstedt, Staffan, et al.
(författare)
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First intercomparison study on the analysis of oxygenated polycyclic aromatic hydrocarbons (oxy-PAHs) and nitrogen heterocyclic polycyclic aromatic compounds (N-PACs) in contaminated soil
- 2014
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Ingår i: TrAC. Trends in analytical chemistry. - : Elsevier. - 0165-9936 .- 1879-3142. ; 57, s. 83-92
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Forskningsöversikt (refereegranskat)abstract
- Oxygenated polycyclic aromatic hydrocarbons (oxy-PAHs) and nitrogen heterocyclic polycyclic aromatic compounds (N-PACs) are toxic, highly leachable and often abundant at sites that are also contaminated with PAHs. However, due to lack of regulations and standardized methods for their analysis, they are seldom included in monitoring and risk-assessment programs. This intercomparison study constitutes an important step in the harmonization of the analytical methods currently used, and may also be considered a first step towards the certification of reference materials for these compounds. The results showed that the participants were able to determine oxy-PAHs with accuracy similar to PAHs, with average determined mass fractions agreeing well with the known levels in a spiked soil and acceptable inter- and intra-laboratory precisions for all soils analyzed. For the N-PACs, the results were less satisfactory, and have to be improved by using analytical methods more specifically optimized for these compounds.
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