{"title":"Outsourcing and Monitoring Preclinical Studies Including GLP Considerations","authors":"P. Mookherjee","doi":"10.1201/9781003124542-20","DOIUrl":"https://doi.org/10.1201/9781003124542-20","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45861517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Nonclinical Safety Strategy for Combinations of Biopharmaceuticals or a Biopharmaceutical with a Small Molecular Weight Compound","authors":"M. Dempster, H. Haggerty","doi":"10.1201/9781003124542-16","DOIUrl":"https://doi.org/10.1201/9781003124542-16","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49080762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Global Regulatory Expectations and Interactions","authors":"M. E. Cosenza","doi":"10.1201/9781003124542-6","DOIUrl":"https://doi.org/10.1201/9781003124542-6","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46342319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Testing for Off-target Binding","authors":"D. Norden, B. Doranz","doi":"10.1201/9781003124542-13","DOIUrl":"https://doi.org/10.1201/9781003124542-13","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44904907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Selection of Relevant Animal Models/Species","authors":"D. Blanset, M. Piazza, E. Musvasva","doi":"10.1201/9781003124542-3","DOIUrl":"https://doi.org/10.1201/9781003124542-3","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41896594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Understanding the Nonclinical Safety Considerations for Therapeutic Oligonucleotides","authors":"C. D. Besten, Scott Henry, A. Levin","doi":"10.1201/9781003124542-27","DOIUrl":"https://doi.org/10.1201/9781003124542-27","url":null,"abstract":"","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45697922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Е. Shtentsel, E. S. Semenova, I. Mashchenko, G. E. Trufanov, T. Pervunina, E. Komlichenko
{"title":"The history of the formation and development of methods of radiation diagnostics in perinatology","authors":"R. Е. Shtentsel, E. S. Semenova, I. Mashchenko, G. E. Trufanov, T. Pervunina, E. Komlichenko","doi":"10.18705/2311-4495-2021-8-3-29-36","DOIUrl":"https://doi.org/10.18705/2311-4495-2021-8-3-29-36","url":null,"abstract":"The article is devoted to the historical aspects of the emergence and development of methods of radiology diagnostics in perinatology — a science that studies the perinatal period and is at the junction of two disciplines: obstetrics and pediatrics. The official recognition of perinatal medicine as an independent direction took place in economically developed countries in 1976 (8 years after the first Congress on Perinatology), when the European Scientific Society of Perinatology was created. One of the most important tasks of perinatology is to assess the condition of the fetus and extrafetal structures, which include the placenta, umbilical cord, fetal membranes. As part of the development of perinatology, new areas of medical science have arisen and continue to actively develop, including radiology diagnostics in perinatology. Currently, during pregnancy, from radiology diagnostic methods, ultrasound and magnetic resonance imaging are safe and informative. The emergence and development of classical X-ray diagnostics is considered separately in the article. Attention is drawn to the current state of the methods of radiology diagnostics when used in perinatology, the order of appointment, indications and contraindications, advantages and disadvantages. The study of the history of the development of radiology imaging in perinatology makes it possible to trace the dynamics of the development of this industry, to analyze the stages of the formation of instrumental research methods during pregnancy. Thanks to the constant development of technology, a large amount of accumulated experience in radiology imaging during pregnancy, the creation of international communities for diagnostics in perinatology and the formation of interdisciplinary approaches for the management of pregnancy, it has become possible to quickly, safely and non-invasively receive information about the condition of a pregnant woman and a fetus.","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41448618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The glymphatic system and its role in the development of Alzheimer’s disease","authors":"S. V. Vorobʼev, S. N. Yanishevskij","doi":"10.18705/2311-4495-2021-8-3-14-21","DOIUrl":"https://doi.org/10.18705/2311-4495-2021-8-3-14-21","url":null,"abstract":"One of the main concepts explaining the development of Alzheimer’s disease is currently the amyloid theory. It was reliably established that the accumulation of the pathological protein amyloid β provokes the launch of a number of pathochemical reactions that ultimately lead to the development of synaptic dysfunction and the formation of cognitive disorders. The protein amyloid β is also synthesized in the brain of people who do not suffer from neurodegenerative pathology. Normally, it is actively removed from the brain. However, the exact mechanisms for maintaining its clearance are not established. The recently discovered glymphatic system claims to be such a component. The present review provides a comprehensive analysis of suggestions that the development of glymphatic system dysfunction contributes to the accumulation of amyloid β and the development of the clinical picture of Alzheimer›s disease.","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45449341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Kozyreva, A. Zlotina, A. Golovkin, O. Kalinina, A. Kostareva
{"title":"Primer designing in Primer-BLAST","authors":"A. Kozyreva, A. Zlotina, A. Golovkin, O. Kalinina, A. Kostareva","doi":"10.18705/2311-4495-2021-8-3-37-52","DOIUrl":"https://doi.org/10.18705/2311-4495-2021-8-3-37-52","url":null,"abstract":"The polymerase chain reaction (PCR) is widely used in different areas. For example, in laboratory diagnostics, PCR is used to detect bacterial and viral pathogens, in the diagnosis of hereditary diseases, and to identify paternity and many other. There are three types of PCR — qualitative, semi-quantitative, and quantitative. The method is based on the ability of DNA polymerase to double the existing DNA strand, thus resulting in multiplication the number of copies of the region of interest. Necessary components of the reaction are DNA or RNA molecules, serving as a template for the of new molecules; polymerase — an enzyme synthesizes new DNA strands; short oligonucleotides – primers that are required for the enzyme work and are specific to the fragment of interest. Currently, there are not many primer designing tools that are easy-to-use and free. One of these tools is the Primer-BLAST online resource, which is integrated with the NCBI database. It is user-friendly and easyto-use effective tool that is integrated with GenBank and RefSeq, and always is up-to-dated. However, even for this tool, there are no detailed instructions for the primers designing. This work is an update for a previously published tutorial and provides a step-by-step guide to find target DNA regions, primers designing, and performing primer quality control. The paper is largely based on the personal experience of the authors and is intended for researchers working with PCR.","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48094008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Pavlyukova, M. V. Kolosova, G. Neklyudova, R. Karpov
{"title":"Left ventricle longitudinal strain of the endocardial and epicardial layers and left ventricle remodelling in children born with low and extremely low body weight aged from one to five years old","authors":"E. Pavlyukova, M. V. Kolosova, G. Neklyudova, R. Karpov","doi":"10.18705/2311-4495-2021-8-2-23-36","DOIUrl":"https://doi.org/10.18705/2311-4495-2021-8-2-23-36","url":null,"abstract":"Background. In last decades, the number of babies born preterm has increased significantly. Premature newborns are more susceptible to cardiovascular disease in the long-term. To identify subclinical myocardial impairment in premature infants, an assessment of of the left ventricle (LV) deformation could be used.Objective. The aim of the study was to study the left ventricle (LV) Longitudinal Strain of the endocardial, middle and epicBardial layers in children born with very low and extremely low body weight, at the age from one to five years.Design and methods. The study included 88 children aged from one to 5 years old, born very premature with very low and extremely low body weight. The comparison group consisted of 43 healthy children of the same age, born full-term. The LV Longitudinal Strain of the endocardial, middle and epicardial layers was studied using the Speckle Tracking Imaging-2D Strain.Results. In children aged 1 to 5 years, born with very low and extremely low body weight, changes in the gradient of transmural wall Strain and a decrease in LV segments longitudinal strain were detected in 15.90 % and 14.77 % of cases, respectively. Mothers of children born prematurely and who subsequently registered disturbance of the transmural gradient of left ventricular strain in 10 cases (71.43 %) had a history of threatened termination of pregnancy. The threat of termination of pregnancy was noted in all women whose children had a decrease in LV segmental strain. In children who have normal of LV segmental strain, the threat of termination of pregnancy in mothers was registered in 16 cases (26.23 %). LV remodeling is observed in children with a change in the gradient of transmural wall strain or and with a decrease in LV longitudinal segment strain. Conclusion. Changes in the transmural gradient of wall deformation or reduction of segmental LV deformation in the longitudinal direction in premature infants require correction of the conventional algorithm of dispensary observation in an outpatient setting.","PeriodicalId":89863,"journal":{"name":"Translational medicine (Sunnyvale, Calif.)","volume":"8 1","pages":"23-36"},"PeriodicalIF":0.0,"publicationDate":"2021-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49486432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}