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development of a Ready-to-Use PSMA-11 Kit Formulation and Biological Evaluation of Binding Affinity

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Advances in Molecular Imaging 2024年第2期13卷 7-22页

作者： Maria Renata Valente Brandão freire Natália Marchesan Bexiga Marco Antonio Stephano João Ezequiel Oliveira Carlos Roberto Jorge Soares Ana Cláudia Camargo Miranda Anna Carolina de Alcântara Barbosa Marycel Figols de Barboza Laura Fernanda Garcia Luiz Felipe S. Teixeira Maria helena Marumo Bellini Natanael Gomes da Silva Luiza Mascarenhas Balieiro Joel Mendes Elaine Bortoleti de Araújo Centro de Radiofarmcia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil departamento de Tecnologia Farmacutica Faculdade de Cincias Farmacuticas (USP) Cidade Universitria So Paulo Brasil Centro de Biotecnologia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil departamento de Medicina Nuclear do Hospital Israelita Albert Einstein So Paulo/SP Brasil

Introduction: 68Ga-PSMA-11 is considered the gold standard in detection of micro and oligometastases in advanced prostate cancer, being used for therapeutic planning, as well as, potentially, for evaluating response to treatment. The development of ready-to-use lyophilized kit of PSMA-11 adds quality and safety to the routine use of this radiopharmaceutical and represents a pharmacotechnical challenge as it must preserve the integrity and specificity of the ligand. Methods: PSMA-11 kit formulation was proposed, considering radiolabeling parameters and the preservation of the peptide during the lyophilization process, using mannitol as an excipient. Critical temperature characterization studies were carried out using DSC equipment and the freeze-drying process was developed. The direct radiolabeling conditions were evaluated and standardized using 68Ge/68Ga generator eluate from two different manufacturers (ITG and Eckert & Ziegler). The radiochemical purity was evaluated by TLC and HPLC. Biological evaluation was carried out with lyophilized PSMA-11 to demonstrate the integrity of the peptide and preservation of biological activity after the lyophilization process. Results: Based on critical temperature characterization studies, the freeze-drying cycle was designed to reach a freezing temperature of around −40˚C and primary drying at 2˚C. Using 20 mg of mannitol, an intact and elegant lyophilized cake was obtained. PSMA-11 lyophilized kit was directly labeled with 68Ga eluate from 68Ge/68Ga GMP generators (ITG and Eckert & Ziegler) resulting in % RP > 95% at pH 4.0 to 4.5. The results obtained from in vitro and in vivo biological competition studies confirmed the preservation of PSMA-11 affinity for the receptor after lyophilization. Conclusion: A lyophilized formulation (Kit) of PSMA-11 was successfully obtained, which preserved the integrity and biological activity of the peptide and guaranteed radiolabeling efficiency.

关键词： 68Ga-PSMA-11 Prostate-Specific Membrane Antigen (PSMA) Ready-to-Use Kit GMP-Grade Generators Metastatic Prostate Cancer PET Imaging

Case report of a criminal dismemberment in Northeast Brazil

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Forensic Sciences Research 2022年第4期7卷 637-642页

作者： Evelyne Pessoa Soriano Maria do Socorro Dantas de Araújo Francisca de Assis Nascimento Pereira Francisca Divina Silveira de Melo Cristiane helena da Silva Barbosa freire Marcus Vitor Diniz de Carvalho Medico-legal Institute of João Pessoa ParaíbaBrazil Faculty of dentistry(FOP) Center for Studies in Forensic Anthropology(CEAF)University of Pernambuco(UPE)RecifeBrazil

Several decomposed body parts were received for examination by the Forensic Anthropology section of the Medico-legal Institute of João Pessoa,Paraíba,*** portions of the lower and upper limbs,ribs,vertebrae,and a skull were thoroughly *** biological profile indicated a male individual with an estimated age range between 23 and 57 years and a mean age of 35.2 years(SD=9.4;phase IV,Suchey-Brooks).The skeleton showed injuries caused by sharp force and sharp-blunt force trauma that affected all body ***,the lesions are mainly in the diaphyseal segments of the long bones,sacrum,pelvis,mandible,maxilla,scapulae,sternum,vertebrae,the distal epiphysis of the left fibula,and the distal epiphysis of the left tibia displayed characteristics compatible with injuries produced *** was not possible to determine the cause of *** resulted in a positive *** of common difficulties faced in forensic practice,it is often not possible for forensic anthropologists to go to the crime scene,X-ray or body scanners are frequently unavailable,and the victim’s medical and/or dental records are sometimes *** difficulties make identification ultimately depend on genetic analysis,which is more time-consuming than other identification *** this,bone fragment examination in dismemberment cases is a complex *** Anthropology can shed light on cases involving the identification of dismembered remains,which are challenging because of the number of traumatic injuries,as well as different injury patterns,on bones.

关键词： Forensic sciences forensic anthropology dismemberment human identification

development of a Ready-to-Use PSMA-11 Kit Formulation and Biological Evaluation of Binding Affinity

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Pressure Ulcers in Institutionalized Elderly People:Association of Sociodemographic and Clinical Characteristics and Risk Factors

Advances in Molecular Imaging（分子影像学） 2024年第2期 7页

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Open Journal of Nursing 2017年第1期7卷 111-122页

作者： Suellen Duarte de Oliveira Matos Iraktania Vitorino Diniz Adriana Lira Rufino de Lucena Smalyanna Sgren da Costa Andrade Karen Krystine Goncalves de Brito Elizabeth Souza Silva de Aguiar Emanuelle Malzac freire de Santana Mailson Marques de Sousa Ana Paula Marques Andrade de Souza Hemílio Fernandes Campos Coelho Mirian Alves da Silva Marta Miriam Lopes Costa Maria Julia Guimaraes Oliveira Soares Simone helena dos Santos Oliveira Graduate Program in Nursing Universidade Federal da ParaíbaJoao PessoaBrazil departament of Statistics Universidade Federal da ParaíbaParaíbaBrazil

Objective: To evaluate the association of socio-demographic and clinical characteristics, and risk factors with occurrence of pressure ulcers in institutionalized elderly people. Method: This cross-sectional, analytical study, in quantitative approach, performed from the database analysis linked to the project “Pressure Ulcer in institutionalized elderly people: Association of incidence with the risk factors to functional and nutritional assessment” developed in six long-stay institutions for the elderly people in João Pessoa. Data were analyzed using the Statistical Package for Social Sciences (SPSS) version 20.0. Associations were made through chi square test and Odds Ratio. Results: The clinical conditions of significant associations with the occurrence of pressure ulcers were the variables neurological disorders (p = 0.011) and visual impairment (p = 0.005). As for risk factors, the most important was fecal incontinence (p Conclusion: The analysis of the associations pointed out problems that require intervention in order to prevent health implications of the elderly people and to minimize the risk and occurrence of this injury.

关键词： Elderly People Institutions for the Elderly People Pressure Ulcer Health Profile Risk Factors