Human volunteer studies with non-pharmaceutical chemicals: metabolism and pharmacokinetic studies.

Abstract:

:1. Human volunteer studies are an essential part of drug development but their use in the area of non-pharmaceutical chemicals has so far been very limited. Such studies can have considerable value in the assessment and improvement of the safe use of chemicals. 2. Once metabolic pathways and target metabolites have been identified in volunteers this information can be used in studies in the workplace or in the general population. Studies should be performed selectively only if there is both a toxic hazard and a significant exposure potential. In addition, they should only be carried out if the required information cannot be obtained in any other way. 3. Volunteer studies with non-pharmaceuticals have become increasingly acceptable in the light of established international guidelines, no-fault compensation, improvements in study design and technical developments which allow the use of very low dose levels. The final decision on whether to carry out a study must always rest with an independent ethical committee. 4. The practical aspects of the study should be specified in a detailed protocol conforming with the principles of good clinical practice. The safety of volunteers must be of paramount concern throughout. Depending on the nature of the chemical and the study, it may be advisable to carry out studies in a clinical facility where equipment is available for the treatment of any emergencies that might occur. 5. Numerous investigators have now shown that human volunteer studies are ethically acceptable, practicable and yield important information. The risk to volunteers is minimal and this approach can lead to an improved foundation for occupational hygiene standards, more accurate risk assessment and thus better protection of the workforce and the general population.

journal_name

Hum Exp Toxicol

authors

Wilks MF,Woollen BH

doi

10.1177/096032719401300604

subject

Has Abstract

pub_date

1994-06-01 00:00:00

pages

383-92

issue

6

eissn

0960-3271

issn

1477-0903

journal_volume

13

pub_type

杂志文章,评审
  • Potential dangers from topical preparations containing methyl salicylate.

    abstract::Methyl salicylate (oil of wintergreen) is widely available in many over-the-counter liniments, ointments, lotions or medicated oils for the relief of musculoskeletal aches and pains. Ingestion of methyl salicylate poses the threat of severe, rapid-onset salicylate poisoning because of its liquid, concentrated form and...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章,评审

    doi:10.1177/096032719601500905

    authors: Chan TY

    更新日期:1996-09-01 00:00:00

  • Induction of apoptosis in indole-3-carbinol-treated lung cancer H1299 cells via ROS level elevation.

    abstract::This study was focused on investigating the anticancer potential of indole-3-carbinol (I3C) against lung cancer H1299 cells via an increase in ROS levels. To investigate the induction of growth arrest and/or cell death in H1299 cells, a cell cycle arrest assay, terminal deoxynucleotidyl transferase (TdT)-mediated dUTP...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327120969968

    authors: Lim HM,Park SH,Nam MJ

    更新日期:2020-10-29 00:00:00

  • Blood lead levels in North Carolina painters.

    abstract::1. Blood lead levels were examined in 127 housepainters in North Carolina between April and September, 1993. Each participant filled out a questionnaire and gave a blood sample. The questionnaire covered the individual's work history, concentrating on paint-removal activities and personal protection, and also covered ...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/096032719501400512

    authors: Ennever FK,Zaccaro DJ,Fernando RA,Jones BT

    更新日期:1995-05-01 00:00:00

  • Impact of pesticides residue and heavy metals on lipids and fatty acids composition of some seafoods of Red Sea (KSA).

    abstract::Seafood is considered by nutritionists to be a high source of omega 3 long-chain polyunsaturated fatty acids (n-3 LC-PUFAs) which are involved in prevention of cardiovascular diseases. The aim of the present study is firstly to detect the presence of organochlorine pesticides and heavy metals in some fresh seafood of ...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327110396535

    authors: Al-Malki AL,Moselhy SS

    更新日期:2011-10-01 00:00:00

  • Morphology of ricin and abrin exposed endothelial cells is consistent with apoptotic cell death.

    abstract::Cultures of bovine pulmonary endothelial (BPE) cells were exposed to LC70 doses of ricin or abrin (15.5 and 4.5 pM respectively) over a period of up to 40 h. The viability of the cultures (as determined by the neutral red (NR) dye retention assay) declined after 6 h exposure to the toxins. From 15 h onwards, cellular ...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/096032719601500513

    authors: Hughes JN,Lindsay CD,Griffiths GD

    更新日期:1996-05-01 00:00:00

  • Quercetin protects rat hepatocytes from oxidative damage induced by ethanol and iron by maintaining intercellular liable iron pool.

    abstract::Accumulating evidence has shown that ethanol-induced iron overload plays a crucial role in the development and progression of alcoholic liver disease. We designed the present study to investigate the potential protective effect of quercetin, a naturally occurring iron-chelating antioxidant on alcoholic iron overload a...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327113499168

    authors: Li Y,Deng Y,Tang Y,Yu H,Gao C,Liu L,Liu L,Yao P

    更新日期:2014-05-01 00:00:00

  • Acute oral toxicity and neurobehavioural toxicological effects of hydroethanolic extract of Boophone disticha in rats.

    abstract::Boophone disticha (B. disticha) has been used systemically in traditional medical practice in Zimbabwe and neighbouring countries for the management of various central nervous system conditions including hysteria. Abuse of the plant by teenagers in Zimbabwe for its claimed hallucinogenic effects has also been reported...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327110384524

    authors: Gadaga LL,Tagwireyi D,Dzangare J,Nhachi CF

    更新日期:2011-08-01 00:00:00

  • Scientific research related to calcium channel blockers poisoning: Bibliometric analysis in Scopus, 1968-2012.

    abstract:PURPOSE:Calcium channel blockers (CCBs) were the most common agents associated with a significant morbidity and mortality rate. The main objective of this study was to examine the publication pattern related to CCBs poisoning at the global level using bibliometric analysis of articles published in SciVerse Scopus onlin...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327115571768

    authors: Zyoud SH,Al-Jabi SW,Sweileh WM,Waring WS

    更新日期:2015-11-01 00:00:00

  • Changes of acetylcholinesterase activity after long-term exposure to sarin vapors in rats.

    abstract::In our study, rats were exposed to sarin vapors for 240 min at four different concentrations (0.30, 0.43, 0.58 and 0.82 microg/L) in a whole-body inhalation chamber. The acetylcholinesterase activity (AChE, EC 3.1.1.7) was measured in the whole blood, frontal cortex (FC), pontomedullar area (PM) and basal ganglia (BG)...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1191/0960327105ht539oa

    authors: Bartosova-Sevelova L,Bajgar J

    更新日期:2005-07-01 00:00:00

  • The compromise of dynamic disulfide/thiol homeostasis as a biomarker of oxidative stress in trichloroethylene exposure.

    abstract::In this study, we aimed to investigate disulfide/thiol homeostasis in trichloroethylene (TCE) exposure. The study was carried out in 30 nonsmoker TCE-exposed workers with a variety of occupations. Additionally, 30 healthy nonsmoker volunteers were recruited as the control group. TCE exposure was determined by measurin...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327115608928

    authors: Bal C,Büyükşekerci M,Koca C,Ağış ER,Erdoğan S,Baran P,Gündüzöz M,Yilmaz Ö

    更新日期:2016-09-01 00:00:00

  • The influence of chronic and subacute exposure to lead on the levels of prolactin, leptin, osteopontin, and follistatin in humans.

    abstract::This study was designed to determine the levels of prolactin, leptin, osteopontin, and follistatin in workers chronically and subacutely exposed to lead compounds. The examined population consisted of three groups. The first group was composed of 56 male workers who were chronically exposed to lead for 13.38 ± 10.38 y...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327116658106

    authors: Dobrakowski M,Kasperczyk A,Czuba ZP,Machoń-Grecka A,Szlacheta Z,Kasperczyk S

    更新日期:2017-06-01 00:00:00

  • Hydrogen sulfide ameliorates cardiovascular dysfunction induced by cecal ligation and puncture in rats.

    abstract::Hydrogen sulfide (H2S) is an endogenously produced gaseous messenger that participates in regulation of cardiovascular functions. This study evaluates the possible protective effect of H2S in cardiovascular dysfunction induced by cecal ligation and puncture (CLP) in rats. After 24 h of induction of CLP, heart rate (HR...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327114564794

    authors: Abdelrahman RS,El-Awady MS,Nader MA,Ammar EM

    更新日期:2015-10-01 00:00:00

  • Human metabolism of aluminium-26 and gallium-67 injected as citrates.

    abstract::1. 26Al and 67Ga were given as citrates to a healthy male volunteer by intravenous injection. The retention of both tracers was studied by body radioactivity measurement. Levels in blood and excreta were determined by gamma-ray spectrometry and/or accelerator mass spectrometry. 2. More than half of the 26Al had left t...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/096032719501400309

    authors: Priest ND,Newton D,Day JP,Talbot RJ,Warner AJ

    更新日期:1995-03-01 00:00:00

  • Systemic absorption of lithium following ingestion of a lithium button battery.

    abstract::Accidental ingestion of electrical batteries occurs commonly in children. This rarely is associated with severe morbidity and mortality. Significant symptoms can arise due to leakage of alkali or heavy metals from the battery after degradation in the gastrointestinal tract. The main heavy metal of concern in electrica...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1191/0960327104ht433oa

    authors: Mallon PT,White JS,Thompson RL

    更新日期:2004-04-01 00:00:00

  • A botulism outbreak from roasted canned mushrooms.

    abstract::Food-borne botulism is a rare disease that results from ingestion of the toxins produced by Clostridium botulinum. The most common cause of the disease is the consumption of home-canned foods prepared under inappropriate conditions, especially in rural environments. In this report, a food-borne botulism outbreak poten...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1191/0960327106ht614oa

    authors: Cengiz M,Yilmaz M,Dosemeci L,Ramazanoglu A

    更新日期:2006-05-01 00:00:00

  • Toxicokinetics of dimethylacetamide (DMAc) in rat isolated perfused liver.

    abstract::Dimethylacetamide (DMAc) is a skin-penetrating solvent able to induce hepatic damage after chronic exposure. Previous research has indicated that metabolism may be saturated at its present TLV/TWA (10 ppm). Biological monitoring of monomethylacetamide (MMAc), the primary metabolite of DMAc, might therefore underestima...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/096032719301200206

    authors: Palmen NG,Evelo CT,Borm PJ,Henderson PT

    更新日期:1993-03-01 00:00:00

  • Pyrvinium pamoate inhibits proliferation and invasion of human endometriotic stromal cells.

    abstract::Endometriosis is characterized by the presence of functional endometrial tissue in other pelvic organs. This gynecologic problem occurs in 35-50% of women with pain and infertility. Endometriotic cells share some characteristics such as proliferation, migration, and invasion with tumor cells. Pyrvinium pamoate, an ant...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327119896612

    authors: Karamian A,Nazarian H,Ziai SA,Zarnani AH,Salehpour S,Paktinat S,Novin MG

    更新日期:2020-05-01 00:00:00

  • Serotonin syndrome due to venlafaxine and maintenance tranylcypromine therapy.

    abstract::A number of novel serotonergic antidepressants have been introduced to clinical practice over the last decade. These medications are felt to be safe alternatives to the traditional tricyclic antidepressants and monoamine oxidase inhibitors, particularly in the overdose setting. Serious adverse reactions and drug inter...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327197016001031

    authors: Hodgman MJ,Martin TG,Krenzelok EP

    更新日期:1997-01-01 00:00:00

  • Effects of endothelin and nitric oxide on cardiac muscle functions in experimental septic shock model.

    abstract::We aimed to investigate the possible roles of nitric oxide (NO) and endothelin on the changes of cardiac muscle function in both hyper- and hypodynamic septic shock periods. Cecal ligation and puncture was performed in 50 Wistar albino rats to induce septic shock. Changes in atrium and right ventricle papillary muscle...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327115583363

    authors: Ozer EK,Iskit AB

    更新日期:2016-03-01 00:00:00

  • Nicotine-induced impairments of spatial cognition and long-term potentiation in adolescent male rats.

    abstract::The aim of the present study was to investigate whether cognitive behavioral impairment, induced by nicotine in offspring rats, was associated with the alteration of hippocampal short-term potentiation (STP) and long-term potentiation (LTP) and to discuss the potential underlying mechanism. Young adult offspring rats ...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327113494902

    authors: Han G,An L,Yang B,Si L,Zhang T

    更新日期:2014-02-01 00:00:00

  • A case of unusual suicidal poisoning by the organophosphorus insecticide dimethoate.

    abstract::A 20-year-old male who attempted suicide by injecting subcutaneously 10 ml of Sistemin 40 (40% dimethoate) was admitted 16 h later. General weakness, muscular fibrillations and a marked inhibition of red blood cell and serum cholinesterases were the prominent signs of intoxication. The antidotal treatment of intermitt...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/096032719000900111

    authors: Jovanović D,Randjelović S,Joksović D

    更新日期:1990-01-01 00:00:00

  • Establishment of a new animal model of azithromycin-induced liver injury and study the molecular pathological change during the process.

    abstract::The purpose of the present study is to establish a new animal model of azithromycin (AZ)-induced liver injury and study the molecular pathological change during the process. First, mice were respectively injected intraperitoneally with AZ of different high doses. Our results showed that 800 mg/kg AZ injection signific...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327115595684

    authors: Li SQ,Wan XD,Zhu S,Han HM,Xu ZS,Lu HJ

    更新日期:2016-05-01 00:00:00

  • Systemic administration with tetrahydrocannabinol causes retinal damage in BALB/c mice.

    abstract::Recent years have seen substantial shifts in cultural attitudes towards cannabis for medical and recreational use. However, legalizing recreational marijuana may have adverse effects on individual and public health. As the most widely used illicit agent, cannabis is commonly reported to disrupt learning and memory. Un...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327119886037

    authors: Zhang Z,Li R,Lu H,Zhang X

    更新日期:2020-03-01 00:00:00

  • The effect of uremic toxin cyanate (OCN–) on anaerobic sulfur metabolism and prooxidative processes in the rat kidney: a protective role of lipoate.

    abstract::Cyanate and its active form isocyanate are formed mainly in the process of nonenzymatic urea biodegradation. Cyanate is capable of protein S- and N-carbamoylation, which can affect their activity. The present studies aimed to demonstrate the effect of cyanate on activity of the enzymes implicated in anaerobic cysteine...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327110394225

    authors: Iciek M,Bilska A,Lorenc-Koci E,Wlodek LB,Sokołowska MM

    更新日期:2011-10-01 00:00:00

  • Safety evaluation of Elixir Paregorico in healthy volunteers: a phase I study.

    abstract::A liquid alcoholic extract of Papaver somniferum named Elixir Paregorico is extensively used for diarrheal diseases in Brazil. Its increased popularity has brought concerns and fears over the safety of this herbal product. Given the lack of investigative clinical studies, in this regard, this study investigated whethe...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327108090274

    authors: de Moraes M,Bezerra M,Bezerra F,de Moraes R,Cavalcanti P,Uchoa C,Lima F,Odorico de Moraes M

    更新日期:2008-10-01 00:00:00

  • Protective effects of Gamma Oryzanol on distant organs after kidney ischemia-reperfusion in rats: A focus on liver protection.

    abstract:BACKGROUND:Acute kidney injury (AKI) is the main clinical concern resulted from ischemia-reperfusion injury (IRI). Ample clinical data indicates that AKI is associated with distant organ dysfunctions and poor patients' outcomes. Oxidative stress and inflammation have a critical role in the pathogenesis of organ injurie...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327120979014

    authors: Bagheri Y,Aghajani S,Hosseinzadeh M,Hoshmandan F,Abdollahpour A,Vahed SZ

    更新日期:2020-12-16 00:00:00

  • Protective effects of melatonin and Glycyrrhiza glabra extract on ochratoxin A--induced damages on testes in mature rats.

    abstract::The effect of Glycyrrhiza glabra extract (GgE) as a natural antioxidant and melatonin (MEL) on ochratoxin A (OTA)-induced histopathological damages on the testes and oxidative stress was evaluated in male rats. The animals were assigned into four groups (n = 8) including control and test groups. The rats in control gr...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327110368416

    authors: Malekinejad H,Mirzakhani N,Razi M,Cheraghi H,Alizadeh A,Dardmeh F

    更新日期:2011-02-01 00:00:00

  • Blood beta-glucuronidase as a suitable biomarker at acute exposure of severe organophosphorus poisoning in human.

    abstract::Organophosphorus compounds are known to cause the selective release of liver microsomal beta-glucuronidase into plasma. Organophophoruses may induce nitrosative stress leading to the generation of nitrogen free radicals and alterations in scavengers of free radicals in many biological systems. In this study, we invest...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/0960327107085349

    authors: Soltaninejad K,Shadnia S,Afkhami-Taghipour M,Saljooghi R,Mohammadirad A,Abdollahi M

    更新日期:2007-12-01 00:00:00

  • Alcohol in cerebrospinal fluid (CSF) and alcoholism.

    abstract::Alcohol levels were measured in 15 cerebrospinal fluid (CSF) samples and 14 blood samples from grade III and IV male alcoholic patients with signs of nervous system involvement, and compared with levels detected in 11 CSF samples and 11 blood samples from abstemious patients or patients with grade I or II alcoholism w...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/096032719201100313

    authors: Agapejev S,Vassilieff I,Curi PR

    更新日期:1992-05-01 00:00:00

  • Modelling dermal pharmacokinetics using in vitro data. Part I. Fluazifop-butyl in the rat.

    abstract::The pharmacokinetics of the herbicide fluazifop-butyl have been determined in female rats following oral and intravenous dosing, and described by a mathematical model. Penetration of fluazifop-butyl through epidermal membranes has been determined using three different receptor fluids. It is demonstrated how this in vi...

    journal_title:Human & experimental toxicology

    pub_type: 杂志文章

    doi:10.1177/096032719301200302

    authors: Auton TR,Ramsey JD,Woollen BH

    更新日期:1993-05-01 00:00:00