Regulatory Toxicology and Pharmacology

Article	Citations
Perspectives on the elimination of animal assays in the assessment of carcinogenicity	98
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	74
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	74
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	72
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	69
Prevalence and sample sizes in pre-clinical studies	68
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids	63
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	57
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	57
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	52
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	52
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay	50
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	49
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	47
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	45
Editorial Board	44
Editorial Board	42
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	41
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	41
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	39
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats	36
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	35
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	33
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	32
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	31

Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	31
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21	29
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	29
Nonclinical safety assessment of engineered T cell therapies	28
The Dilemma of perfluorooctanoate (PFOA) human half-life	28
Exploring the potential of ToxCast™ data for mechanism-based prioritization of chemicals in regulatory context: Case study with priority existing chemicals (PECs) under K-REACH	28
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	28
Chemical interactions and mixtures in public health risk assessment: An analysis of ATSDR's interaction profile database	27
Editorial Board	27
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	27
Case study on the impact of the source of metabolism parameters in next generation physiologically based pharmacokinetic models: Implications for occupational exposures to trimethylbenzenes	26
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	25
Threshold of Toxicological Concern: Extending the chemical space by inclusion of a highly curated dataset for organosilicon compounds	25
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	24
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	24
Feasibility study for a downsized comparative thyroid assay with measurement of brain thyroid hormones and histopathology in rats: Case study with 6-propylthiouracil and sodium phenobarbital at high d	24
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	24
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	24
Editorial Board	23
Editorial Board	23
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	23
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	21
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	21
Evaluating H295R steroidogenesis assay data for robust interpretation	21
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	21
Nonclinical evaluation of abuse liability of the dual orexin receptor antagonist lemborexant	20
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	20
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	19
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	19
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	19
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	19
The purity of tattoo inks, screening substances of high concern	19
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits	19
Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	18
A systematic approach to evaluate plausible modes of actions for mouse lung tumors in mice exposed to 4-methylimidozole	18
Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7)	18
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	18
Modeling extraction of medical device polymers for biocompatibility evaluation	18
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	18
Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults	18
Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment	17
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China	17
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	16
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	16
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection	16
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	16
Preclinical safety assessment of the crude extract from Sida rhombifolia L. aerial parts in experimental models of acute and repeated-dose 28 days toxicity in rats	15
Integration of toxicodynamic and toxicokinetic new approach methods into a weight-of-evidence analysis for pesticide developmental neurotoxicity assessment: A case-study with DL- and L-glufosinate	15
Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost	15
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	15

N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular w	15
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	15
Residue depletion profiles and withdrawal interval estimations of meloxicam in eggs and ovarian follicles following intravenous (Meloxicam solution for injection) and oral (Meloxidyl®) administration	14
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 2 b: Reactive cobalt substances induce oxidative stress in ToxTracker and activate hypoxia target genes	14
Rebuttal to the letter to the editors regarding Van Berlo et al. (2022) paper titled “10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	14
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	14
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products	14
Dealing with substances with no defined molecular weight in non-animal assays for skin sensitization. A comment on “Plant extracts, polymers and new approach methods: Practical experience with skin se	14
Carcinogenicity testing in drug development: Getting it right	14
Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories	14
Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation	14
Absence of developmental or reproductive toxicity in rats for MB-102, a fluorescent tracer agent for point-of-care measurement of glomerular filtration rate	14
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	14
Contributions of the joint FAO/WHO expert committee on food additives to international food safety: celebrating the 100th meeting of the committee	13
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	13
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	13
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	13
Inter-laboratory performance of ICE histopathology scoring to identify UN GHS Category 1 surfactants and non-extreme pH detergents	13
Refinement of decision tree to assess the consequences of increased serum ALP in dogs: Additional analysis on toxicity studies of pesticides evaluated recently in Japan	13
The Botanical Safety Consortium: A public-private partnership to enhance the botanical safety toolkit	13
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	13
Reply to Comment on “Reduced specificity for the local lymph node assay for lipophilic chemicals: Implications for the validation of new approach methods for skin sensitization” by Roberts and Baskett	13
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	13
Six-well plate-based colony-forming efficacy assay and Co-Culture application to assess toxicity of metal oxide nanoparticles	13
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	13
Corrigendum to “Use of an aggregate exposure model to estimate consumer exposure to fragrance ingredients in personal care and cosmetic products” [Regul. Toxicol. Pharmacol. 72 3 (2015) 673-68]	12
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	12
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment	12
Systematic review of the potential carcinogenicity of bisphenol A in humans	12
Editorial Board	12
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	12
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	12
R-ODAF: Omics data analysis framework for regulatory application	12
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	12
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	11
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	11
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	11
Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies	11
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	11
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	11
Development and application of a systematic and quantitative weighting framework to evaluate the quality and relevance of relative potency estimates for dioxin-like compounds (DLCs) for human health r	11
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	11
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis	11
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	11
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice	11
Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits	11
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	11
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	11
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	11
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	10
Editorial Board	10
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans	10
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	10
Three-tiered approach for standard information requirements for polymers requiring registration under REACH	10
Application of a new approach method (NAM) for inhalation risk assessment	10
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	10
Rebuttal to the letter to the editors regarding Van Berlo et al. (2022) paper titled “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	10
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	10
Editorial Board	9
Development of COVID-19 therapies: Nonclinical testing considerations	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	9
Inhalation cancer risk assessment for environmental exposure to hexavalent chromium: Comparison of margin-of-exposure and linear extrapolation approaches	9
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	9
Effects of as-if risk framing of hazards on risk perception and its rebuttal	9
A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment	9
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	9
Evaluation of the safety of ethanolic extract from Piper amalago L. (Piperaceae) leaves in vivo: Subacute toxicity and genotoxicity studies	9
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis	9
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	9
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	9
GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations	9
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	9
Health safety of parabens evaluated by selected in vitro methods	9
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	9
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	9
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
What happened to quinacrine non-surgical female sterilization?	8
Afidopyropen: Challenges and impact of a toxicokinetic study designed to identify a point of inflection from dose-proportionality	8
The safety of a Kluyveromyces lactis strain lineage for enzyme production	8
Comparison of toxicological effects and exposure levels between triclosan and its structurally similar chemicals using in vitro tests for read-across case study	8

Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)	8
A reproductive and developmental toxicity screening study of 1,3-butadiene in Sprague-Dawley rats	8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8
Case analysis of kinetics investigations in toxicity studies of pesticides to identify the nonlinearity of internal exposure and the influences of nonlinearity on the toxicological interpretation of p	8
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials	8
A 90-day subchronic toxicity study of Myrrh in F344 rats	8
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432	8
A scoping review of infant and children health effects associated with cadmium exposure	8
The new paradigm in animal testing – “3Rs alternatives”	8
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	8
Best practices for exposure model peer review – A SciPinion advisory panel report	8
Editorial Board	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8
Food for thought — Paving the way for a UK roadmap towards optimum consumer safety: Development, Endorsement and Regulatory acceptance of New Approach Methodologies (NAMs) in Chemical Risk Assessment	8
Aloe-emodin, a hydroxyanthracene derivative, is not genotoxic in an in vivo comet test	8
Exposure considerations in human safety assessment: Report from an EPAA Partners’ Forum	7
Recommendation for an occupational exposure limit for toluene	7
Derivation of subacute guidance values for chemical contaminants of drinking water quality standard in Japan	7
Propylene oxide derived glycol ethers: A review of the alkyl glycol ethers potential to cause endocrine disruption	7
Model systems and organisms for addressing inter- and intra-species variability in risk assessment	7
Use of biomarker data and metabolite relative potencies to support derivation of noncancer reference values based on the reproductive and developmental toxicity effects of 1,3-butadiene	7
The discovery and preclinical pharmacology of JNJ-10450232 (NTM-006), a centrally penetrant, non-opioid structural analog of acetaminophen with comparable analgesic and anti-pyretic properties but no	7
Comparison of carbonyls and tobacco-specific nitrosamines in aerosols of heated tobacco products and conventional cigarette smoke using both targeted and untargeted analytical methods	7
Fluoride concentrations in drinking water and health risk assessment in the south of Algeria	7
Preclinical safety assessment of JNJ-10450232 (NTM-006), a structural analog of acetaminophen, that does not cause hepatotoxicity at supratherapeutic doses	7
Expansion of the Cosmetics Europe skin sensitisation database with new substances and PPRA data	7
Response to letter to editor “letter to the editors regarding “the Conundrum of the PFOA human half-life, an international collaboration.”	7
Adeno-associated virus (AAV)-based gene therapy products: What are toxicity studies in non-human primates showing us?	7
REACHing for solutions: Essential revisions to the EU chemicals regulation to modernise safety assessment	7
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines	7
Safe- and sustainable-by-design: The case of Smart Nanomaterials. A perspective based on a European workshop	7
Statistical applications of virtual control groups to nonrodent animal toxicity studies: An initial evaluation	7
Liver biomarkers in adults: Evaluation of associations with reported green tea consumption and use of green tea supplements in U.S. NHANES	7
Biomonitoring Equivalents for N,N-Diethyl-meta-toluamide (DEET)	7
Editorial: Looking back and forward	6
Risk assessment of nutrients: There must be a threshold for their effects	6
A tiered approach to investigate the inhalation toxicity of cobalt substances. Introduction: Cobalt's essential role in nature and technology	6
Can “Hazard-Cost-Effectiveness Analysis” improve the risk management of chemicals under REACH?	6
Letter to the editors regarding “The conundrum of the PFOA human half-life, an international collaboration”	6
SCCS scientific opinion on HAA299 (nano) - SCCS/1634/21	6
Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?	6
2000–2023 over two decades of ICH S7A: has the time come for a revamp?	6
Applicability of nanomaterial-specific guidelines within long-term Daphnia magna toxicity assays: A case study on multigenerational effects of nTiO2 and nCeO2 exposure in the presence of artificial da	6
Tiered human health risk assessment of antibacterial quaternary ammonium compounds (QACs) in dishwashing detergents	6
Subchronic safety assessment of CIGB-500 in beagle dog after repeated daily dose administration over 28 days	6
Analytical chemistry solutions to hazard evaluation of petroleum refining products	6
Semiquantitative sensitization safety assessment of extractable and leachables associated with parenteral pharmaceutical products	6
A toxicological evaluation for safety assessment of ruthenium-based diosmetin complex in rats	6
Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety – A proposal for further actions	6
An Overview of Choice of Reference Biological Medicines in Current Turkish Biosimilar Guideline	6
Formation and evaluation of mechanism-based chemical categories for regulatory read-across assessment of repeated-dose toxicity: A case of hemolytic anemia	6
Editorial Board	6
Editorial Board	6
A new paradigm for regulatory sciences	6
Mode of action Criteria for selection of the critical effect and safe dose range for PFOA by the Alliance for risk assessment	6
Letter to the editor regarding “A systematic review of adverse health effects associated with oral cadmium exposure”	6
Correct calculations of a “safe” daily dose of raw materials for homeopathic remedies. Re: Toxicological assessment compilation of selected examples of raw materials for homeopathic and anthroposophic	6
Is schedule IV suvorexant an appropriate reference drug of abuse to use in preclinical abuse liability testing in the rat?	6
Determination of inorganic arsenic, heavy metals, pesticides and mycotoxins in Indian rice (Oryza sativa) and a probabilistic dietary risk assessment for the population of Saudi Arabia	6
Comparison of PAC and MOAH for understanding the carcinogenic and developmental toxicity potential of mineral oils	6
Review of air concentrations of pesticides for estimating exposure to vapour in European risk assessments	6
Monosodium glutamate in a type 2 diabetes context: A large scoping review	6
Safety assessment of phytase transgenic maize 11TPY050 in Sprague-Dawley rats by 90-day feeding study	6
In vivo alkaline comet assay: Statistical considerations on historical negative and positive control data	6
The role of trust in the use of artificial intelligence for chemical risk assessment	6
Calculating qualified non-mutagenic impurity levels: Harmonization of approaches	6
Systematic update to the mammalian relative potency estimate database and development of best estimate toxic equivalency factors for dioxin-like compounds	6
Experiences and initiatives on pharmacokinetic modeling and simulation data analysis: Perspectives from the Brazilian Health Regulatory Agency (ANVISA)	6
Implications of variability on medical device chemical equivalence assessment	5
Reproductive and developmental toxicity assessment of HSK21542, a novel peripherally-restricted kappa opioid receptor agonist in rats and rabbits	5
A framework to mitigate the risk of chemical leukoderma: Consumer products	5
Association between metal exposure from e-cigarette components and toxicity endpoints: A literature review	5
First-in-human study to evaluate the safety, tolerability and pharmacokinetics of a novel analgesic and antipyretic drug with structural similarity to acetaminophen	5
Animal use and opportunities for reduction in carcinogenicity studies supporting approved new drug applications in the U.S., 2015–2019	5
Toxicological evaluation of S. involucrata culture: Acute, 90-day subchronic and genotoxicity studies	5
Re-evaluation of the reduced heart weights in male rats in a 28-day oral repeated-dose toxicity study of tetramethylammonium hydroxide	5
The need for guidance in antidepressant drug development: Revisiting the role of the forced swim test and tail suspension test	5
Ambient air concentrations of plant protection products: Data collection for the combined air concentration database and associated risk assessment	5
Neurobehavioral assessment of BMEDA by modified Irwin test in Sprague-Dawley rats	5
Biomonitoring Equivalents for ethylene thiourea	5
An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the European Union	5
Quantitative Structure Use Relationships: Highlights from a technical summit meeting	5
Acute and sub chronic toxicity studies with herbal pain relieving formula (Rhuleave-K™) in rats	5
The Conundrum of the PFOA human half-life, an international collaboration	5
Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency	5
Response to the Letter to the Editor by David W Roberts “Dealing with substances with no defined molecular weight in non-animal assays for skin sensitization. A comment on “Plant extracts, polymers an	5
A 10-step framework for use of read-across (RAX) in next generation risk assessment (NGRA) for cosmetics safety assessment	5
Biomonitoring and risk assessment of human exposure to triazole fungicides	5
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products	5
Next generation risk assessment for skin allergy: Decision making using new approach methodologies	5
Preliminary clinical pharmacokinetic evaluation of bemotrizinol - A new sunscreen active ingredient being considered for inclusion under FDA's over-the-counter (OTC) sunscreen monograph	5
A tiered approach to investigate the inhalation toxicity of cobalt substances. Tier 4: Effects from a 28-day inhalation toxicity study with tricobalt tetraoxide in rats	5
Minimizing the risk of ethylene glycol and diethylene glycol poisoning in medications: A regulatory and pharmacopoeial response	5
Ethyl acrylate (EA) exposure and thyroid carcinogenicity in rats and mice with relevance to human health	5
Monitoring and risk assessment of hazardous chemicals in toy-slime and putty in the Netherlands	5