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Clinical Toxicology

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https://www.readbyqxmd.com/read/28630216/fractionated-dosing-improves-preclinical-therapeutic-index-of-pyrrolobenzodiazepine-containing-antibody-drug-conjugates
#1
Mary Jane Hinrichs, Pauline M Ryan, Bo Zheng, Shameen Afif-Rider, Xiang-Qing Yu, Michele Gunsior, Haihong Zhong, Jay Harper, Binyam Bezabeh, Kapil Vashisht, Marlon Rebelatto, Molly Reed, Patricia C Ryan, Shannon Breen, Neki Patel, Cui Chen, Luke A Masterson, Arnaud Tiberghien, Philip W Howard, Nazzareno Dimasi, Rakesh Dixit
                Purpose:  To use preclinical models to identify a dosing schedule that improves tolerability of highly potent pyrrolobenzodiazepine dimers (PBD) antibody drug conjugates (ADCs) without compromising anti-tumor activity.  <p>                Experimental design:   A series of dose-fractionation studies were conducted to investigate the pharmacokinetic drivers of safety and efficacy of PBD ADCs in animal models.  The exposure-activity relationship was investigated in mouse xenograft models of human prostate cancer, breast and gastric cancer by comparing anti-tumor activity after single and fractionated dosing with tumor-targeting ADCs conjugated to SG3249, a potent PBD dimer...
June 19, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28625099/toxicology-in-clinical-laboratories-challenging-times
#2
N W Brown
In recent years, there have been a number of significant developments in toxicology within clinical laboratories, both with the available instrumentation and in the range of compounds abused by the drug using communities. There have also been developments in the regulation of forensic science in the UK which may in time impact clinical toxicology. This review is designed to provide an update of these changes within toxicology to the more general pathology laboratory audience. For detailed information in specific areas, the reader is referred to the references in the text...
June 19, 2017: British Journal of Biomedical Science
https://www.readbyqxmd.com/read/28624430/comparative-assessment-of-immune-complex-mediated-hypersensitivity-reactions-with-biotherapeutics-in-the-nonhuman-primate-critical-parameters-safety-assessment-and-lessons-for-future-studies
#3
Sven Kronenberg, Elisabeth Husar, Christine Schubert, Christian Freichel, Thomas Emrich, Martin Lechmann, Anna Maria Giusti, Franziska Regenass
With the emergence of novel biotherapeutic formats and immunostimulatory biotherapeutics in cancer immunotherapy, an understanding of immune-complex (IC) mediated hypersensitivity reactions in toxicology studies - and their differentiation from pharmacology - remains key to the preclinical evaluation of these drugs. In this review we provide an in-depth evaluation and comparison of case examples where IC-mediated hypersensitivity reactions were observed in cynomolgus monkeys. We provide details of the parameters evaluated in each study to substantiate and guide the interpretation of these findings...
June 14, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28623915/safety-pharmacology-and-subchronic-toxicity-of-jinqing-granules-in-rats
#4
Xuerong Zhou, Qian Rong, Min Xu, Yuanli Zhang, Qi Dong, Yuanling Xiao, Qiji Liu, Helin Chen, Xiaoyu Yang, Kaisheng Yu, Yinglun Li, Ling Zhao, Gang Ye, Fei Shi, Cheng Lv
BACKGROUND: Jinqing granules which are made of a mixture extract that contains Radix Tinosporae and Canarii fructus in proportions according to a longstanding formula have a good effect on the prevention and treatment of gastric ulcer disease. It has not been through safety through systematic toxicological studies, however. To provide basis for clinical application, we performed safety pharmacology and subchronic toxicity experiments in specific pathogen-free Sprague-Dawley rats. RESULTS: In safety pharmacology experiments, Jinqing granules had no evident adverse effects on the central nervous, cardiovascular, or respiratory systems...
June 17, 2017: BMC Veterinary Research
https://www.readbyqxmd.com/read/28615926/mechanistic-modelling-of-drug-induced-liver-injury-investigating-the-role-of-innate-immune-responses
#5
Lisl Km Shoda, Christina Battista, Scott Q Siler, David S Pisetsky, Paul B Watkins, Brett A Howell
Drug-induced liver injury (DILI) remains an adverse event of significant concern for drug development and marketed drugs, and the field would benefit from better tools to identify liver liabilities early in development and/or to mitigate potential DILI risk in otherwise promising drugs. DILIsym software takes a quantitative systems toxicology approach to represent DILI in pre-clinical species and in humans for the mechanistic investigation of liver toxicity. In addition to multiple intrinsic mechanisms of hepatocyte toxicity (ie, oxidative stress, bile acid accumulation, mitochondrial dysfunction), DILIsym includes the interaction between hepatocytes and cells of the innate immune response in the amplification of liver injury and in liver regeneration...
2017: Gene Regulation and Systems Biology
https://www.readbyqxmd.com/read/28613973/the-association-of-cannabis-use-on-inpatient-psychiatric-hospital-outcomes
#6
Melanie Rylander, Helena R Winston, Haley Medlin, Madelyne Hull, Abraham Nussbaum
BACKGROUND: The associations between cannabis use and psychosis are well documented in numerous studies. There is a need to evaluate the impact of cannabis use on inpatient psychiatric utilization and outcomes. OBJECTIVES: To evaluate the impact of cannabis use on psychiatric hospital outcomes. METHODS: This study was conducted between April 20, 2015 and October 20, 2015. All patients (n = 120) admitted to Denver Health with psychotic symptoms were administered a urine toxicology screening testing for the presence of 11-nor-9-carboxy-Δ(9)-tetrahydrocannabinol (THC-COOH, the active metabolite of cannabis)...
June 14, 2017: American Journal of Drug and Alcohol Abuse
https://www.readbyqxmd.com/read/28608865/cardiological-aspects-of-carbon-monoxide-poisoning
#7
Jakub Marchewka, Iwona Gawlik, Grzegorz Dębski, Lech Popiołek, Wojciech Marchewka, Piotr Hydzik
AIM: The aim of this study was to assess cardiological manifestations of carbon monoxide (CO) poisoning. Background/introduction: Carbon monoxide intoxication is one of the most important toxicological causes of morbidity and mortality worldwide. Early clinical manifestation of CO poisoning is cardiotoxicity. MATERIALS AND METHODS: We enrolled 75 patients (34 males and 41 females, mean age 37.6 ± 17.7 y/o) hospitalized due to CO poisoning. Laboratory tests including troponin I, blood pressure measurements, HR and electrocardiograms (ECG) were collected...
2017: Folia Medica Cracoviensia
https://www.readbyqxmd.com/read/28603745/lentivector-iterations-and-pre-clinical-scale-up-toxicity-testing-targeting-mobilized-cd34-cells-for-correction-of-fabry-disease
#8
Ju Huang, Aneal Khan, Bryan C Au, Dwayne L Barber, Lucía López-Vásquez, Nicole L Prokopishyn, Michel Boutin, Michael Rothe, Jack W Rip, Mona Abaoui, Murtaza S Nagree, Shaalee Dworski, Axel Schambach, Armand Keating, Michael L West, John Klassen, Patricia V Turner, Sandra Sirrs, C Anthony Rupar, Christiane Auray-Blais, Ronan Foley, Jeffrey A Medin
Fabry disease is a rare lysosomal storage disorder (LSD). We designed multiple recombinant lentivirus vectors (LVs) and tested their ability to engineer expression of human α-galactosidase A (α-gal A) in transduced Fabry patient CD34(+) hematopoietic cells. We further investigated the safety and efficacy of a clinically directed vector, LV/AGA, in both ex vivo cell culture studies and animal models. Fabry mice transplanted with LV/AGA-transduced hematopoietic cells demonstrated α-gal A activity increases and lipid reductions in multiple tissues at 6 months after transplantation...
June 16, 2017: Molecular Therapy. Methods & Clinical Development
https://www.readbyqxmd.com/read/28601767/pooled-human-liver-preparations-heparg-or-hepg2-cell-lines-for-metabolism-studies-of-new-psychoactive-substances-a-study-using-mdma-mdbd-butylone-mdppp-mdpv-mdpb-5-mapb-and-5-api-as-examples
#9
Lilian H J Richter, Veit Flockerzi, Hans H Maurer, Markus R Meyer
Metabolism studies play an important role in clinical and forensic toxicology. Because of potential species differences in metabolism, human samples are best suitable for elucidating metabolism. However, in the case of new psychoactive substances (NPS), human samples of controlled studies are not available. Primary human hepatocytes have been described as gold standard for in vitro metabolism studies, but there are some disadvantages such as high costs, limited availability, and variability of metabolic enzymes...
May 18, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28598140/biomarker-profiling-of-plasma-samples-for-various-diseases-utilizing-randox-biochip-array-technology
#10
Jennifer Saluk, Debra Hoppensteadt, Danyel Syed, Jeffrey Liles, Schuharazad Abro, Amanda Walborn, Vinod Bansal, Jawed Fareed
RANDOX Biochip Array Technology offers an efficient, cost-effective method of measuring multiple analytes on a large number of samples in biologic fluids. This innovative technology has proven extremely useful in the profiling of markers in a number of different disease states. Biochip arrays have also shown promise in clinical trials, offering rapid evaluation of multiple markers and circulating levels of the analyte with only a small sample. This biochip technology has broad applications in clinical, pharmaceutical, toxicological, immunologic and microbiologic areas...
June 9, 2017: International Angiology: a Journal of the International Union of Angiology
https://www.readbyqxmd.com/read/28597920/a-case-of-nonfatal-intoxication-associated-with-the-recreational-use-of-diphenidine
#11
Enrico Gerace, Elena Bovetto, Daniele Di Corcia, Marco Vincenti, Alberto Salomone
Diphenidine is a dissociative drug that shows several psychotropic effects including euphoria, shifts in perception of reality, hallucinations, and transient anterograde amnesia. In this study, a case of acute intoxication occurring after diphenidine intake is reported. A 30-year-old Caucasian male was hospitalized after he was found in a confused and agitated state and unable to communicate. The physical examination displayed tachycardia, miotic pupils, and increased both body temperature and respiratory rate...
June 9, 2017: Journal of Forensic Sciences
https://www.readbyqxmd.com/read/28595930/a-novel-hybrid-product-that-heats-tobacco-through-controlled-aerosol-release-part-2-in%C3%A2-vitro-biological-assessment-and-comparison-with-different-tobacco-heating-products
#12
Damien Breheny, Jason Adamson, David Azzopardi, Andrew Baxter, Emma Bishop, Tony Carr, Ian Crooks, Katherine Hewitt, Tomasz Jaunky, Sophie Larard, Frazer Lowe, Oluwatobiloba Oke, Mark Taylor, Simone Santopietro, David Thorne, Benjamin Zainuddin, Marianna Gaça, Chuan Liu, James Murphy, Christopher Proctor
This study assessed the toxicological and biological responses of aerosols from a novel hybrid tobacco product. Toxicological responses from the hybrid tobacco product were compared to those from a commercially available Tobacco Heating Product (c-THP), a prototype THP (p-THP) and a 3R4F reference cigarette, using in vitro test methods which were outlined as part of a framework to substantiate the risk reduction potential of novel tobacco and nicotine products. Exposure matrices used included total particulate matter (TPM), whole aerosol (WA), and aqueous aerosol extracts (AqE) obtained after machine-puffing the test products under the Health Canada Intense smoking regime...
May 30, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/28595532/pharmacological-and-toxicological-profile-of-harmane-%C3%AE-carboline-alkaloid-friend-or-foe
#13
Haroon Khan, Seema Patel, Mohammad A Kamal
The plant secondary metabolites have an outstanding therapeutic potential and success over the years. In fact, it is the foundation of numerous clinically used drugs. Similarly, there is a general perception that these products usually have safe option. However, such products might have toxic/unwanted lethal effects therefore, along with biological relevance, toxicological evaluation is equally important for clinical applications. Harmane-β-carboline alkaloid has shown several pharmacological activities such as antianxiety, antidepressant, antiplatelet, antidiabetic, acetylcholinesterase and myeloperoxidase inhibition, antioxidant, antiparasitic, hypotensive, morphine withdrawal syndrome alleviation, and antinociceptive effects...
June 6, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28595500/the-genus-patrinia-a-review-of-traditional-uses-phytochemical-and-pharmacological-studies
#14
Xirui He, Fei Luan, Zefeng Zhao, Ning Ning, Maoxing Li, Ling Jin, Yu Chang, Qiang Zhang, Ni Wu, Linhong Huang
The aim of the present review is to comprehensively outline the botanical description, traditional uses, phytochemistry, pharmacology and toxicology of Patrinia, and to discuss possible trends for the further study of medicinal plants from the genus Patrinia. The genus Patrinia plays an important role in Asian medicine for the treatment of erysipelas, conjunctival congestion with swelling and pain, peri-appendicular abscesses, lung carbuncle, dysentery, leucorrhea, and postpartum disease. More than 210 chemical constituents have been isolated and identified from Patrinia plants, especially P...
2017: American Journal of Chinese Medicine
https://www.readbyqxmd.com/read/28594246/a-review-of-vilazodone-exposures-with-focus-on-serotonin-syndrome-effects
#15
C William Heise, Hannah Malashock, Daniel E Brooks
BACKGROUND: Vilazodone is an antidepressant with selective serotonin reuptake inhibition and partial 5HT1A agonism. Serotonin syndrome is believed to be due to excessive stimulation of 5-HT2A and 5-HT1A receptors, resulting in the clinical triad of altered mentation, autonomic instability and neuromuscular abnormalities. The goal of this study is to define serotonergic effects after vilazodone exposure. METHODS: A retrospective review of two databases: the American Association of Poison Controls Centers' National Poison Data System (NPDS) and the American College of Medical Toxicology's Toxicology Investigators Consortium (ToxIC Registry)...
June 8, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28592788/levamisole-induced-leukocytoclastic-vasculitis-with-negative-serology-in-a-cocaine-user
#16
Mashal Salehi, Michael P Morgan, Abigail Gabriel
BACKGROUND Levamisole is a common adulterant of cocaine. It can cause agranulocytosis and cutaneous vasculitis that can possibly lead to cutaneous necrosis. In all reported cases of levamisole-induced vasculitis, it has been described as a clinical syndrome characterized by a constellation of typical clinical features and a positive serum serology for ANCA levels, especially very high-titer p-ANCA levels, in the background of cocaine abuse. However, patients may have a negative serology and here, we present the first such case...
June 8, 2017: American Journal of Case Reports
https://www.readbyqxmd.com/read/28586416/bridging-the-gap-between-reproducibility-and-translation-data-resources-and-approaches
#17
Caroline J Zeiss, Linda K Johnson
Animal research has constituted a fundamental means to achieve groundbreaking therapies for human disease. However, for complex diseases, promising preclinical results have failed to translate to the clinic. Reasons for this disparity are multifactorial. These include the challenges inherent in modeling complex disease in animals, as well issues of study design, reproducibility and operational norms within the biomedical research enterprise. In this issue, we explore the range of information resources available for the comparative study of disease, as well as challenges to the ultimate translation of preclinical findings...
June 6, 2017: ILAR Journal
https://www.readbyqxmd.com/read/28583701/the-american-academy-of-clinical-toxicology-question-of-the-day
#18
Ryan Surmaitis, Masood Khalid, Rita McKeever, David Vearrier, Michael Greenberg
No abstract text is available yet for this article.
June 2, 2017: Disease-a-month: DM
https://www.readbyqxmd.com/read/28583045/recommendations-for-clinical-pathology-data-generation-interpretation-and-reporting-in-target-animal-safety-studies-for-veterinary-drug-development
#19
William Siska, Aradhana Gupta, Lindsay Tomlinson, Niraj Tripathi, Barbara von Beust
Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests...
January 1, 2017: International Journal of Toxicology
https://www.readbyqxmd.com/read/28579071/tranylcypromine-in-mind-part-ii-review-of-clinical-pharmacology-and-meta-analysis-of-controlled-studies-in-depression
#20
REVIEW
Roland Ricken, Sven Ulrich, Peter Schlattmann, Mazda Adli
It has been over 50 years since a review has focused exclusively on the monoamine oxidase (MAO) inhibitor tranylcypromine (TCP). A new review has therefore been conducted for TCP in two parts which are written to be read preferably in close conjunction: part I - pharmacodynamics, pharmacokinetics, drug interactions, toxicology; and part II - clinical studies with meta-analysis of controlled studies in depression, practice of TCP treatment, place in therapy. The irreversible and nonselective MAO-A/B inhibitor TCP has been confirmed as an efficacious and safe antidepressant drug...
June 1, 2017: European Neuropsychopharmacology: the Journal of the European College of Neuropsychopharmacology
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