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Litigation trends in the EU, EU Member States, and UK
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
Against this backdrop, the French Mediator case law adopted an even more restrictive interpretation of the defence. In particular, the Cour de Cassation rejected the Servier’s argument that the product defect could not be discovered at the time of product supply (in that case, 1998–2008), and ruled that the product’s defect could have been detected as early as 1997. This is because, by that time, the harmful effects of medicinal products with a similar chemical composition and metabolic action had already been revealed. This interpretation recognises that a product’s defect may also be discovered “by analogy” with similar products. This significantly restricts the scope of application of the development risk defence. In addition, the Cour de Cassation added that the product had been withdrawn from the market in Switzerland in 1998, put under surveillance in other countries, and eventually withdrawn in Spain and Italy. These regulatory decisions were adopted considering pharmacovigilance reports and international studies on the potential role of the Mediator in the development of pulmonary arterial hypertension and valve disease. Consequently, the Cassation concluded that, when the Mediator was put into circulation, the state of scientific and technical knowledge made it possible to detect its defect and, therefore, Servier could not invoke the development risk defence.71
Translation of Tissue Engineering Approach from to Clinics
Published in Vincenzo Guarino, Marco Antonio Alvarez-Pérez, Current Advances in Oral and Craniofacial Tissue Engineering, 2020
Daniel Chavarría-Bolaños, José Vega-Baudrit, Bernardino Isaac Cerda-Cristerna, Amaury Pozos-Guillén, Mauricio Montero-Aguilar
Since all the experiments needed vary from one product to another, let us discuss the possible steps to develop 3D-SCAFF. First, all the single materials to be used must be characterized individually, determining their chemical composition, purity and behavior under different conditions (such as temperature changes, variable pH, pressure modifications or light exposure). Understanding each material will predict how they will behave once combined and may help to select and adapt the fabrication method. 3d printing—as an example—sometimes requires modifying the polymer temperature or the printing pattern; especially when an active molecule is added to the polymer. Once a possible combination is obtained, several mechanical tests will determine how the biomaterial will behave in the body and will predict the maximum load of force or deformation that may suffer. Different chemical analysis will also analyze the stability of the combinations, and the integrity of the added active molecules, such as drugs. Some vulnerable molecules may become inactive after preparation processes, so controlled release assays and bioactivity research must be conducted to determine if the loaded drug is still present.
Cosmetic Camouflage in Vitiligo
Published in Vineet Relhan, Vijay Kumar Garg, Sneha Ghunawat, Khushbu Mahajan, Comprehensive Textbook on Vitiligo, 2020
Feroze Kaliyadan, Karalikkattil T. Ashique, Ambika Kumar
Dermatologists should be aware of all the camouflage products available for vitiligo. The dermatologist must be well-versed with the techniques of application and the relative advantages/disadvantages of different products. It is also important to know the actual chemical composition of these products, especially in the context of patients having previous allergic reactions to various cosmetics. Ideally, specialized consultations should be available for patients to educate them on camouflage techniques. Dermatology clinics should have a “camouflage therapist,” a specialist who educates and helps the patient choose an appropriate color and teaches them how to apply the color to normalize their appearance [3]. Ideally, these consultations should involve a multidisciplinary team including trained nurses, camouflage specialists, and the dermatologist. Studies have shown that attendance at specialized camouflage clinics can improve the quality of life in vitiligo patients [10,26]. One of the primary aims must to be to train patients to effectively choose and apply the cosmetic camouflage by themselves. For children, the guardians should be trained in the process [1,14].
Effect of in vitro simulated digestion on the anti-Helicobacter Pylori activity of different Propolis extracts
Published in Journal of Enzyme Inhibition and Medicinal Chemistry, 2023
Paolo Governa, Giulia Romagnoli, Paola Albanese, Federico Rossi, Fabrizio Manetti, Marco Biagi
Propolis is a resinous product made by honeybees to repair and protect the hives, preventing the microbial infection of larvae. Its chemical composition varies depending on the vegetal origin and geographical region where it was produced, affecting the physical properties, such as colour, smell, taste, and consistency. Flavonoids are widely present in most of the propolis, independently from the origin.36 Flavones, such as chrysin and acacetin, are mostly present in the temperate region-native propolis, while flavonols, such as galangin and quercetin, are mostly present in Eurasian propolis. Pinocembrin, a flavanone, is commonly found in different propolis, independently from the origin.36 Other frequently found constituents include caffeic acid phenethyl ester (CAPE),37 phenolic acids (such as benzoic acid, gallic acid, caffeic acid, cinnamic acid, and chlorogenic acid), and terpenes.36
Lung cell toxicity of co-exposure to airborne particulate matter and extremely low-frequency magnetic field
Published in Xenobiotica, 2022
Zahra Panjali, Parviz Abdolmaleki, Behnam Hajipour-Verdom, Omar Hahad, Rezvan Zendehdel
Based on the viability assessment in A549 cells, it was found that the toxicity of airborne TPM was lower than the Fe–Cr and Fe–Si and higher than the Fe–Mn. The specific chemical composition is a crucial factor influencing toxicity. The elemental analysis showed that 51% of the total mass in Fe–Si consists of silica (Panjali et al. 2021), while more than 1.3% of silica was determined in air samples. In this case, the stronger toxicity of Fe–Cr compared to air samples may be related to the presence of Ni, Cr, and Cu in the furnace feeding component. However, the smaller silica content in Fe-Mn compared to other particles highlighted higher cell viability in this treatment. On the other hand, the previous studies have sampled from pure silica (Lison et al. 2008), while co-exposure to silica and metals caused the increased toxicity (Simone et al. 2013). Also, exposure to the mixture of Cr and heavy metals enhanced cell toxicity (Saud Alarifi and Alkahtani 2016; Terpilowska and Siwicki 2018).
Comparison the sensitivity of amphibian metamorphosis assays with NF 48 stage and NF 51 stage Xenopus laevis tadpoles
Published in Toxicology Mechanisms and Methods, 2019
Yin-Feng Zhang, Hai-Ming Xu, Fei Yu, Hong-Yu Yang, Dong-Dong Jia, Pei-Feng Li
X. laevis frogs (Nasco, Fort Atkins, WI) and tadpoles were raised in glass tanks containing charcoal-filtered tap water. Housing and breeding conditions were reported in our previous studies (Lou et al. 2013; Zhang et al. 2014). The water quality was as follows: without chlorine, pH 6.5–7.0, dissolved oxygen concentration >5 mg/L, iodine concentration 2.14–3.92 μg/L, and water hardness (CaCO3) approximately 150 mg/L. Adult female and male X. laevis (3 years old) were raised separately in glass tanks at 22 ± 2 °C with a 12 h light/12 h dark cycle, and fed with chopped pork liver: commercial amphibian diet (Totoro Supplies, Hong Kong, China) (1:1) three times a week. The chemical composition of the commercial diet is as follows, nutrients: protein 45.3%, fat 45.3%, and fiber 2.3%; minerals: ash, 9.2%, calcium, 2.04%, phosphorus, 1.44%, potassium, 0.93%, magnesium, 0.22%, sodium, 0.22%, and so on; Vitamins: carotene, ppm: 0.10, vitamin B, ppm,37, niacin, ppm, 240, vitamin A, IU/gm, 9, vitamin D3 (added), IU/gm, 2.4, vitamin E, IU/kg, 110, and so on. A pair of X. laevis was injected by HCG (male 300 IU and female 700 IU) to induce breeding. Fertilized eggs were incubated in the dechlorinated tap water at 22 ± 2 °C. On the fifth day post-fertilization, tadpoles were fed with live Artemia three times every day, and the amount of live Artemia was adjusted as the animals developed. The tadpoles were staged according to the Nieuwkoop and Faber system (Nieuwkoop and Faber 1994).