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Model-Informed Drug Development
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
The disease model represents three aspects of information: (i) the relationship between biomarkers and clinical outcomes, (ii) natural disease progression, and (iii) placebo effect. There are three general approaches to developing disease models: systems biology, semimechanistic and empirical models. The systems biology and semimechanistic/mechanistic models have been introduced in the above sections. Empirical disease model are merely mathematical models to interpolate between observed data. For instance, the relationship between the change in tumor size and survival is typically described using empirical parametric hazard models.
Modelling human neurodegeneration using induced pluripotent stem cells
Published in Christine Hauskeller, Arne Manzeschke, Anja Pichl, The Matrix of Stem Cell Research, 2019
Iryna Prots, Beate Winner, Jürgen Winkler
As mentioned in the previous paragraphs, deep knowledge of the mechanisms driving human neurodegeneration could create the proper background for the development of new reliable diagnostic tests or for more effective treatments of neurodegenerative diseases. Disease mechanisms can be more easily discovered if one has a good disease model that provides knowledge about early markers and/or early disease pathways. The best model for investigating human disease mechanisms would be a human model. However, human material (except blood) affected by disease is difficult or impossible to obtain from a living human, especially with regard to disorders of the nervous system. With the establishment of iPSC technology, neurological research has received a significant boost as it opens new avenues to obtain patient-specific, disease-relevant human cells and to utilize those for modelling disease processes (Park et al., 2008). It also gives researchers the possibility of following the disease in a relevant patient-specific human system from the very early stage over its progression up to the late stage. In this section, we try to think about the iPSC potency for the treatment of neurodegenerative diseases.
Premenstrual Syndrome: A Bio-Psycho-Social Approach to Treatment
Published in Diana L. Taylor, Nancy F. Woods, Menstruation, Health, and Illness, 2019
Peg Miota, Mary Yahle, Carole Bartz
Historically, women have sought help from professionals for physical symptoms often related to the reproductive system. Moreover, physical symptoms can be manifestations of intense emotional needs. In a patriarchal society, physical symptoms are more acceptable than emotional pain. Furthermore, women are expected to care for others rather than for themselves. These cultural factors may suggest to women that they must be physically ill before they can care for themselves. The disease model, which encourages defining physical and emotional changes as illnesses, reinforces this perspective. The program at the psychiatric hospital offers women an alternative to the traditional disease model of treatment.
A Brazilian multicentre study on the clinical and epidemiological profiles of 1116 patients with amyotrophic lateral sclerosis and its phenotypic variants
Published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 2022
Christian Marques Couto, Elisa de Melo Queiroz, Renata Nogueira, Ana Paula Pires Duarte Küsel, Osvaldo J. M. Nascimento
Previous Brazilian cohort studies reported a mean age at onset varying from 52.8 to 54.9 years (13). This is in line with our findings of an overall median age of 55 years. In addition, those numbers are very similar to those in cohorts from South American and African countries (31,32) but much younger than the usual range of 60 to 65 years reported in US and European populations (33). The earlier onset in developing countries is well established, but the reasons for this are not. One possible explanation would be that shorter life expectancies could distort the incidence and prevalence curves, leading to more patients in their fifth and sixth decades of life. Another point to consider is that in a genetic-environmental disease model (34), sociodemographic characteristics negatively affect disease progression.
Systematic literature review of health economic models developed for multiple myeloma to support future analyses
Published in Journal of Medical Economics, 2023
Mimi Choon-Quinones, Tamás Zelei, Bertalan Németh, Manna Tóth, Xiao Yang Jia, Mike Barnett, Paul Keown, Brian Durie, Jean-Luc Harousseau, Dirk Hose, Zoltán Kaló
Gonzalez-McQuire et al. conducted an SLR to guide the development of an MM conceptual model that could be applied in MM economic modelling74. Their conceptual model focused on the relevance of disease and patient characteristics on MM progression and clinical outcomes; a Delphi panel of hematologists emphasized the significance of disease activity (i.e. M-protein, serum-free light chain levels, bone marrow plasma cell count). As noted in our SLR, these disease activity markers were rarely tracked in the previously developed MM health economic models. To our knowledge between our literature search date and the submission of this manuscript, no papers on whole disease models have been published, that are capable of covering the entirety of the disease spectrum.
On the suitability of medical analogies, from hypertension to broken leg
Published in The World Journal of Biological Psychiatry, 2019
Georg S. Kranz, Siegfried Kasper
However, the use of a metaphor to illustrate the biological nature of a psychiatric illness must be preceded by an appraisal of the audience and of the circumstances in which we plan to use the metaphor. Lecturing our patients about the nature of a psychiatric illness should help, rather than hinder, the therapeutic process, and we may need to separate what we believe is the truth and what is therapeutically helpful. Indeed, it has been argued that the clinical and public utility of a purely neurobiological model of psychiatric illness has its limits. A disease model that is derived from a dialogue between the patient and the clinician that makes sense for the patient may be a more solid basis upon which successful treatments can be built (Malla et al. 2015).