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International Journal of Toxicology最新文献

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Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine. D-PLEX100在幼年小型猪腹部手术切口模型中的临床前体内安全性和毒代动力学。
IF 1.2 4区 医学
International Journal of Toxicology Pub Date : 2024-01-01 Epub Date: 2023-10-03 DOI: 10.1177/10915818231205222
Yuval Ramot, Abraham Nyska, Meidan Dvir, Shlomo Nedvetzki, Sefi Rosenfeld, Noam Emanuel
{"title":"Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine.","authors":"Yuval Ramot, Abraham Nyska, Meidan Dvir, Shlomo Nedvetzki, Sefi Rosenfeld, Noam Emanuel","doi":"10.1177/10915818231205222","DOIUrl":"10.1177/10915818231205222","url":null,"abstract":"<p><p>D-PLEX100 (D-PLEX) is a novel product candidate made of a polymer-lipid-based matrix (PLEX platform) which contains doxycycline that is being released at a constant rate for 30 days. D-PLEX was developed to prevent surgical site infections, which are a major global health challenge. Previous studies have shown its safety in adult humans, adult swine, and adult rabbits. The aim of this study was to assess the toxicity and safety of D-PLEX also in juvenile animals to support future clinical trials in pediatric patients. Yucatan miniature swine were selected as a model, primarily due to their relatively larger mass. D-PLEX or placebo (formulation without doxycycline) was administered locally to abdominal incisions, and the animal's safety parameters were followed for 9 months and compared to sham-control swine. There was no evidence of any systemic safety concern or local toxicity at the incision site in D-PLEX-treated animals. D-PLEX was detected after 1 month and was fully resorbed at the 3-month time point. The surgical incision sites were fully healed at the 6-month time point in all D-PLEX-treated animals. Toxicokinetic (TK) assessments revealed that doxycycline exhibited low C<sub>max</sub> and therefore minimal systemic exposure following a single dose of local administration. This study provides evidence for the safety of D-PLEX and PLEX-based formulation in juvenile miniature swine and supports its further testing in clinical pediatric population. In addition, it can be used as a reference for future preclinical studies aiming to evaluate the safety of other PLEX-based product candidates for the pediatric population.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"19-26"},"PeriodicalIF":1.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851645/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41137078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Editor's Note. 编者按
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2024-01-01 Epub Date: 2023-12-06 DOI: 10.1177/10915818231220244
{"title":"Editor's Note.","authors":"","doi":"10.1177/10915818231220244","DOIUrl":"10.1177/10915818231220244","url":null,"abstract":"","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"3"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138487451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Book Review: Drug Disposition and Pharmacokinetics: Principles and Applications for Medicine, Toxicology and Biotechnology 书评：药物处置与药代动力学：医学、毒理学和生物技术的原理与应用
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-23 DOI: 10.1177/10915818231224018
Leanne L. Bedard
{"title":"Book Review: Drug Disposition and Pharmacokinetics: Principles and Applications for Medicine, Toxicology and Biotechnology","authors":"Leanne L. Bedard","doi":"10.1177/10915818231224018","DOIUrl":"https://doi.org/10.1177/10915818231224018","url":null,"abstract":"","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"32 3","pages":""},"PeriodicalIF":2.2,"publicationDate":"2023-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139161685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
American College of Toxicology 美国毒理学学院
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-18 DOI: 10.1177/10915818231220242
{"title":"American College of Toxicology","authors":"","doi":"10.1177/10915818231220242","DOIUrl":"https://doi.org/10.1177/10915818231220242","url":null,"abstract":"","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"26 ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2023-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139175834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Spontaneous Incidence of Neurological Clinical Signs in Preclinical Species Using Cage-side Observations or High-definition Video Monitoring: A Retrospective Analysis 使用笼边观察或高清视频监控临床前物种神经临床症状的自发发生率：回顾性分析
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-08 DOI: 10.1177/10915818231218984
Chiara Orciani, Cristina Ballesteros, E. Troncy, Clemence Berthome, K. Bujold, Nehla Bennamoune, Samantha Sparapani, M. Pugsley, Dominique Paquette, Emmanuel Boulay, S. Authier
{"title":"The Spontaneous Incidence of Neurological Clinical Signs in Preclinical Species Using Cage-side Observations or High-definition Video Monitoring: A Retrospective Analysis","authors":"Chiara Orciani, Cristina Ballesteros, E. Troncy, Clemence Berthome, K. Bujold, Nehla Bennamoune, Samantha Sparapani, M. Pugsley, Dominique Paquette, Emmanuel Boulay, S. Authier","doi":"10.1177/10915818231218984","DOIUrl":"https://doi.org/10.1177/10915818231218984","url":null,"abstract":"When conducting toxicology studies, the interpretation of drug-related neurological clinical signs such as convulsions, myoclonus/myoclonic jerks, tremors, ataxia, and salivation requires an understanding of the spontaneous incidence of those observations in commonly used laboratory animal species. The spontaneous incidence of central nervous system clinical signs in control animals from a single facility using cage-side observations or high definition video monitoring was retrospectively analyzed. Spontaneous convulsions were observed at low incidence in Beagle dogs and Sprague–Dawley rats but were not identified in cynomolgus monkeys and Göttingen minipigs. Spontaneous myoclonic jerks and muscle twitches were observed at low incidence in Beagle dogs, cynomolgus monkeys, and Sprague–Dawley rats but were not seen in Göttingen minipigs. Spontaneous ataxia/incoordination was identified in all species and generally with a higher incidence when using video monitoring. Salivation and tremors were the two most frequent spontaneous clinical signs and both were observed in all species. Data from the current study unveil potential limitations when using control data obtained from a single study for toxicology interpretation related to low incidence neurological clinical signs while providing historical control data from Beagle dogs, cynomolgus monkeys, Sprague–Dawley rats, and Göttingen minipigs.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"15 4","pages":""},"PeriodicalIF":2.2,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138587878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Isopropyl Lanolate. Lanolate异丙基。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-25 DOI: 10.1177/10915818231203383
Monice Fiume, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Bart Heldreth
{"title":"Isopropyl Lanolate.","authors":"Monice Fiume, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Bart Heldreth","doi":"10.1177/10915818231203383","DOIUrl":"10.1177/10915818231203383","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1980, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Isopropyl Lanolate is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"56S-57S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41176007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Sulfites. 亚硫酸盐。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-10-16 DOI: 10.1177/10915818231204569
Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth
{"title":"Sulfites.","authors":"Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204569","DOIUrl":"10.1177/10915818231204569","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1998, along with updated information regarding product types and concentrations of use, and confirmed that Sodium Sulfite, Potassium Sulfite, Ammonium Sulfite, Sodium Bisulfite, Ammonium Bisulfite, Sodium Metabisulfite, and Potassium Metabisulfite are safe as cosmetic ingredients in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"110S-114S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41235249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PEG Soy Sterols. PEG大豆甾醇。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-26 DOI: 10.1177/10915818231204279
Priya Cherian, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth
{"title":"PEG Soy Sterols.","authors":"Priya Cherian, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204279","DOIUrl":"10.1177/10915818231204279","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in year 2000, along with updated information regarding product types and concentrations of use, and confirmed that PEG-5, -10, -16, -25, -30, and -40 Soy Sterol are safe as cosmetic ingredients in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"83S-85S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41130816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Polyamino Sugar Condensate. 聚酰胺糖冷凝液。
IF 1.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-27 DOI: 10.1177/10915818231204239
Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth
{"title":"Polyamino Sugar Condensate.","authors":"Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204239","DOIUrl":"10.1177/10915818231204239","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1982, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Polyamino Sugar Condensate is safe for topical application to humans in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"91S-92S"},"PeriodicalIF":1.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41178855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recent Advances in Drug Discovery Toxicology. 药物发现与毒理学的最新进展。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-07-15 DOI: 10.1177/10915818231189659
Bowen Tang, Vijay More
{"title":"Recent Advances in Drug Discovery Toxicology.","authors":"Bowen Tang, Vijay More","doi":"10.1177/10915818231189659","DOIUrl":"10.1177/10915818231189659","url":null,"abstract":"<p><p>Major advances in scientific discovery and insights that stem from the development and use of new techniques and models can bring remarkable progress to conventional toxicology. Although animal testing is still considered as the \"gold standard\" in traditional toxicity testing, there is a necessity for shift from animal testing to alternative methods regarding the drug safety testing owing to the emerging state-of-art techniques and the proposal of 3Rs (replace, reduce, and refine) towards animal welfare. This review describes some recent research methods in drug discovery toxicology, including in vitro cell and organ-on-a-chip, imaging systems, model organisms (<i>C. elegans</i>, <i>Danio rerio</i>, and <i>Drosophila melanogaster</i>), and toxicogenomics in modern toxicology testing.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"535-550"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9834905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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