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Litigation trends in the USA
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
Within this complex evaluation process, the primary methodologies for proving general causation95 include epidemiological studies,96 dose-response relationship,97 and background risk of disease.98 A general causation opinion is generally considered unreliable if it is not supported by at least one of these primary methodologies.99 While “secondary” methodologies such as biological plausibility,100 case studies101 and adverse event reports,102 extrapolations from animal103 and in vitro studies,104 and extrapolations from analogous medicines105 do not warrant per se general causation, they may strengthen a general causation opinion already based on one of the primary methodologies.
SARS-CoV-2 Morphology, Genomic Organisation and Lifecycle
Published in Srijan Goswami, Chiranjeeb Dey, COVID-19 and SARS-CoV-2, 2022
Srijan Goswami, Ushmita Gupta Bakshi
There were significant concerns among the scientific community that ACEIs and ARBs may increase an individual's susceptibility to SARS-CoV-2 as well as increasing the possibility of severe COVID-19 illness (Wiese et al., 2020; Lanza et al., 2020). As reported by Wan et al., the concern of the scientific community regarding the relation of ACEIs and ARBs with COVID-19 is based on analysis of biological plausibility (Wiese et al., 2020; Lanza et al., 2020). The word biological plausibility refers to the result of research or a trial which are believable in terms of current scientific biological knowledge. An article published by the World Health Organization, titled ‘COVID-19 and the Use of Angiotensin Converting Enzyme Inhibitors and Receptor Blockers: A Scientific Brief', dated 7 May 2020 (WHO, 2020b), concluded the following:The researchers did not find any studies that were designed to directly evaluate whether the susceptibility to COVID-19 is related to ACEIs or ARBs (WHO, 2020a).There were no studies that addressed the potential benefits and harm of initiating ACEIs or ARBs as a treatment for patients with COVID-19 (WHO, 2020a).There is low certainty evidence that patients on long-term therapy with ACEIs or ARBs are not at higher risk of poor outcomes from COVID-19 (WHO, 2020a).
Epidemiology
Published in Samuel C. Morris, Cancer Risk Assessment, 2020
Biologic Plausibility. The association is plausible given pre-existing biological knowledge. Plausibility may not be as useful a criterion as it may seem. It is quite often possible to find biologically plausible explanations for even contradictory findings. There is great subjective incentive to find justification for one’s research results. Also, while causality must be judged on the existing body of knowledge, it is always possible that a new, seemingly implausible result is correct and reflects a flaw in preexisting knowledge.
Hypothesis-driven weight of evidence evaluation indicates styrene lacks endocrine disruption potential
Published in Critical Reviews in Toxicology, 2023
All 22 studies were evaluated using the Toxicological data Reliability Tool, knowns as ToxRTool. The tool comprises a list of 21 criteria for in vivo studies and 18 criteria for in vitro studies. Each criterion is assigned a value of either “1” (criterion met) or “0” (criterion not met); thus, a maximum reliability score of 21 is possible. Criteria are divided into five groups: I. Test substance identification, II. Test system characterization, III. Study design description, IV. Study results documentation and V. Plausibility of study design and results. Eleven of the 22 studies used in this evaluation (1, 2, 3. 4, 5, 12, 15, 16, 18, 19, 22) met all ToxRTool reliability criteria (21 for in vivo and 18 for in vitro studies). Appendix A provides a summary of ToxRTool evaluations for all 22 studies, including the numerical designation for each study used in Supplementary Tables 1–6, and an explanation of deficiencies for studies that did not meet all criteria.
Systematic review of the potential respiratory carcinogenicity of metallic nickel in humans
Published in Critical Reviews in Toxicology, 2020
Robyn L. Prueitt, Wenchao Li, Yu-Chi Chang, Paolo Boffetta, Julie E. Goodman
We then used the evaluation of causation and human relevance in experimental studies to assess whether there is high, moderate, or inadequate confidence in the biological plausibility of metallic nickel exposure causing respiratory cancer in humans, or high or moderate confidence in a lack of biological plausibility, using the scheme outlined in Table 2. If the body of experimental evidence demonstrated causation and human relevance, then we concluded that there is high confidence that metallic nickel exposure causing respiratory cancer in humans is biologically plausible. If there was inadequate evidence regarding human relevance, but the experimental study results supported causation, we concluded that there is moderate confidence that exposure to metallic nickel causing respiratory cancer in humans is biologically plausible. If the experimental study results indicate that the relationship between metallic nickel exposure and respiratory cancer is not causal and there is either evidence in support of human relevance or inadequate evidence to determine human relevance, we concluded that there is either high or moderate confidence (respectively) that metallic nickel exposure causing respiratory cancer in humans is not biologically plausible. In all other cases, we concluded that there is inadequate evidence to assess biological plausibility.
Cognitive and mood side effects of lower urinary tract medication
Published in Expert Opinion on Drug Safety, 2019
A. Elif Muderrisoglu, Klaus F. Becher, Stephan Madersbacher, Martin C. Michel
The elderly exhibit a wide range of multimorbidity and polypharmacy [4], e.g. with declining cognitive abilities and an increased prevalence of mood disturbance. They may also be more vulnerable to adverse effects of medication on function of the central nervous system (CNS) such as cognition and mood because of a more permissive blood-brain-barrier [5] and drug-drug or drug–disease interactions. As recent reports have highlighted a possible risk of LUTS medication to exert adverse effects on cognition and mood, we review the evidence in this regard derived from controlled clinical studies in patients and volunteers as well as observational and epidemiological studies. Such clinical evidence is linked to research findings to explore mechanistic plausibility. In this analysis, we will focus on the drug classes of anti-muscarinics, α-blockers, and ARIs because they are the most frequently used LUTS medications. Limited evidence on other drug classes will be discussed only briefly.