Regulatory Toxicology and Pharmacology

Article	Citations
A review of common approaches to determining allocation factors and relative source contribution factors for drinking water contaminants: caveats and areas for improvement	108
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats	92
Prevalence and sample sizes in pre-clinical studies	91
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls	87
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy	86
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats	69
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations	66
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines	61
Risk assessment and pharmacokinetic modeling of incidental ingestion of ethanol from mouthwash	59
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents	51
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol	47
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?	46
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)	43
HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions	41
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes	41
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk	41
Nonclinical development of advanced therapies: Best practices for translational and regulatory success	39
Editorial Board	38
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	37
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan	37
Toltrazuril sulfone (Ponazuril) residue depletion in pig tissues and estimated withdrawal intervals	36
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents	35
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology	35
Editorial Board	34
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review	34

Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer	34
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test	31
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator	31
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice	30
A tool to support food substance safety evaluations in the United States	30
Physiologically based pharmacokinetic modeling of oseltamivir in pregnant rhesus macaques to inform clinical dosing across trimesters	29
Inter-species variability in 4,4′-methylenedianiline metabolism: insights from human and rat precision-cut liver slices	29
Editorial Board	28
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model	28
Expert panel evaluation of the tumor modes of action for 1,4-dioxane and their implications for human risk assessment	28
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice	27
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)	27
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop	27
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support	27
Editorial Board	26
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)	26
Case study on the impact of the source of metabolism parameters in next generation physiologically based pharmacokinetic models: Implications for occupational exposures to trimethylbenzenes	25
Editorial Board	25
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals	25
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients	25
Retrospective evaluation of the use of non-human primates for fertility assessment of pharmaceuticals submitted for marketing approval in the EU	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	23
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments	22
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals	22
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats	22
Evaluating H295R steroidogenesis assay data for robust interpretation	22
Commentary on FDA's shift from animal testing and implications for drug attrition – The time to act is now	22
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment	22
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments	22
The value of a structured, systematic approach to benefit-risk assessment of medicines: A South African regulator case study	21
Evaluating the lifetime cumulative dose as a basis for carcinogenic potency of nitrosamines – a key tenet underpinning less-than-lifetime approaches for establishing acceptable intake limits	21
The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley rats	21
Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment	21
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach	21
Modeling extraction of medical device polymers for biocompatibility evaluation	20
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel	20
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China	20
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century	20
Smoke Flavoring-a case study demonstrating the value of using Benefit-risk analysis for foods (BRAFO) to provide transparency for risk management decisions	19
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”	18
Safe usage levels of aqueous Hippophae rhamnoides fruit extract in cosmetics estimated by threshold of toxicological concern, point of departure, and history of safe consumption	18
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats	18
Exposure and disease burden of fumonisins and aflatoxins from sorghum consumption in Ethiopia	18
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate	18
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure	17
Dose level selection for developmental and reproductive toxicology (DART) studies: Insights from the EUROTOX 2024 satellite workshop	17
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays	17
Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) “New Approach Methodologies (NAMs) User Forum Kick-Off Workshop”	17
Evaluating cancer risks: The impact of thirdhand smoke exposure on carcinogenesis	17
Assessment of endocrine disruptors in the European Union: Current regulatory framework, use of new approach methodologies (NAMs) and recommendations for improvements	17

In vivo screening evaluation of 12 chemicals as candidate endocrine disruptors using ovariectomized mouse uterotrophic bioassay	17
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection	16
Regulatory experience with the comparative in vitro metabolism study based on an analysis of 70 studies with pesticide active ingredients – a reality check	16
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model	16
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	16
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products	16
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	16
Residue depletion profiles and withdrawal interval estimations of meloxicam in eggs and ovarian follicles following intravenous (Meloxicam solution for injection) and oral (Meloxidyl®) administration	16
Occurrence and dietary risk assessment of pesticide residues in bananas and kiwifruits from Turkey	15
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP	15
Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation	15
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel	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
Unknown confidence in chemical characterization identification levels: When tentative identifications are adequate for toxicological risk assessment of medical devices	15
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States	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
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides	14
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	14
Contributions of the joint FAO/WHO expert committee on food additives to international food safety: celebrating the 100th meeting of the committee	13
Acute and sub-acute toxicity assessment of methanolic extract from Clerodendrum infortunatum flowers	13
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database	13
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products	13
Carcinogenicity testing in drug development: Getting it right	13
Talc fits the framework of poorly soluble low-toxicity particles - implications for hazard classification	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]	13
Absence of developmental or reproductive toxicity in rats for MB-102, a fluorescent tracer agent for point-of-care measurement of glomerular filtration rate	13
Development of a digital tool for semi-quantitative assessment of pesticide exposure risk in greenhouses	13
A new method of consistency evaluation of brain drugs: a case study of edaravone	13
Systematic review of the potential carcinogenicity of bisphenol A in humans	13
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals	13
Toxicity reference values for force health protection: Provisional occupational exposure guidelines	12
Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits	12
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties	12
Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology	12
Editorial Board	12
R-ODAF: Omics data analysis framework for regulatory application	12
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese	12
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey	12
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening	12
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
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds	11
Evaluation of good review practices at the Food and Drugs Authority of Ghana as it strives to become a World Health Organization-listed agency	11
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)	11
Prolonged exposure to nitrate in drinking water does not adversely impact prenatal or birth outcomes in a rat model	11
Learning from experience: A retrospective analysis of read-across strategies for surfactants under REACH	11
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants	11
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage	11
Safety and regulatory assessment of heat-killed Lactiplantibacillus plantarum strain L-137 (HK L-137) as a food ingredient	11
Demonstration of safety for rice bran wax and sunflower wax based on bridging to other naturally derived waxes used in foods	10
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/21	10
The utility of hERG channel inhibition data in the derivation of occupational exposure limits	10
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review	10
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542	10
Elucidation of 28 day repeated oral dose induced genotoxicity potential of nickel (II) oxide nanoparticles in wistar albino rats	10
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum	10
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration	10
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations	10
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen	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
Establishing best practice for N-nitrosamine read-across and surrogate selection	9
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats	9
Use of NAMs in a weight of evidence approach to evaluate the safety via the inhalation route of acetylated vetiver oil, in spray products	9
Serial blood collection in anaesthetised rats: Enhancing animal welfare without the need for jugular vein catheterisation	9
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”	9
GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations	9
A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment	9
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens	9
Health safety of parabens evaluated by selected in vitro methods	9
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis	9
Editorial Board	9
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications	9
Effects of as-if risk framing of hazards on risk perception and its rebuttal	9
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497	9
Development of COVID-19 therapies: Nonclinical testing considerations	9
Towards EU regulatory hazard assessment of metabolic endocrine disrupters: Integrating new biomarkers into OECD test guidelines	9
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes	9
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals	8
Lack of significant risk from everyday dietary nickel: Rethinking the application of oral toxicity reference values	8
Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)	8

Editorial Board	8
The new paradigm in animal testing – “3Rs alternatives”	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
Comparison of toxicological effects and exposure levels between triclosan and its structurally similar chemicals using in vitro tests for read-across case study	8
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies	8
An extended Reference Chemical Potency List (RCPL) for characterising the performance of New Approach Methodologies (NAMs) in measuring the skin sensitisation potency of fragrance chemicals	8
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology	8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia	8
Ames concordance with the in vivo transgenic rodent (TGR) gene mutation assay for NDSRIs and relative in vivo TGR potency with nitrosamines with robust dose-response carcinogenicity data	8
Toxicology of bromoform, a natural constituent of the seaweed Asparagopsis spp. used to inhibit methanogenesis in cattle, suggests negligible risks to humans	8
A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs	8
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis	8
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice	8
Nitrosamine drug substance-related impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation	8
Quantitative risk assessment of allergens leaching from menstrual hygiene products	8
Substantiating chemical groups for read-across using molecular response profiles	8
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects	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
REACHing for solutions: Essential revisions to the EU chemicals regulation to modernise safety assessment	7
Statistical applications of virtual control groups to nonrodent animal toxicity studies: An initial evaluation	7
2000–2023 over two decades of ICH S7A: has the time come for a revamp?	7
Biomonitoring Equivalents for N,N-Diethyl-meta-toluamide (DEET)	7
Evaluating high-throughput assays for pesticide ecological risk assessment	7
Editorial Board	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
Expansion of the Cosmetics Europe skin sensitisation database with new substances and PPRA data	7
Adeno-associated virus (AAV)-based gene therapy products: What are toxicity studies in non-human primates showing us?	7
In vivo alkaline comet assay: Statistical considerations on historical negative and positive control data	7
Propylene oxide derived glycol ethers: A review of the alkyl glycol ethers potential to cause endocrine disruption	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
Preclinical safety assessment of JNJ-10450232 (NTM-006), a structural analog of acetaminophen, that does not cause hepatotoxicity at supratherapeutic doses	7
Recommendation for an occupational exposure limit for toluene	7
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines	7
A new paradigm for regulatory sciences	7
Model systems and organisms for addressing inter- and intra-species variability in risk assessment	7
Systematic update to the mammalian relative potency estimate database and development of best estimate toxic equivalency factors for dioxin-like compounds	7
Exposure considerations in human safety assessment: Report from an EPAA Partners’ Forum	7
Best practices for exposure model peer review – A SciPinion advisory panel report	7
Reproductive and developmental toxicity risk assessment for 4-methylimidazole	7
Response to letter to editor “letter to the editors regarding “the Conundrum of the PFOA human half-life, an international collaboration.”	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
Letter to the editors regarding “The conundrum of the PFOA human half-life, an international collaboration”	6
Do co-formulants influence plant protection product genotoxicity?	6
Radon concentration and physicochemical properties measurement and internal exposure assessment in different brands of commercial soft drinks consumed in Türkiye	6
Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency	6
Platform-based opportunities to streamline animal use in support of the 3Rs – recommendations from an antibody-drug conjugate analysis	6
The role of trust in the use of artificial intelligence for chemical risk assessment	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
A toxicological evaluation for safety assessment of ruthenium-based diosmetin complex in rats	6
Editorial: Looking back and forward	6
Derivation of subacute guidance values for chemical contaminants of drinking water quality standard in Japan	6
Can “Hazard-Cost-Effectiveness Analysis” improve the risk management of chemicals under REACH?	6
Rivastigmine as an alternative in physostigmine shortage for anticholinergic toxicity treatment	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
Formation and evaluation of mechanism-based chemical categories for regulatory read-across assessment of repeated-dose toxicity: A case of hemolytic anemia	6
Comparison of PAC and MOAH for understanding the carcinogenic and developmental toxicity potential of mineral oils	6
Use of human data for risk assessment of pesticides: A review including an evaluation of trichlorfon as case study	6
Semiquantitative sensitization safety assessment of extractable and leachables associated with parenteral pharmaceutical products	6
Mode of action Criteria for selection of the critical effect and safe dose range for PFOA by the Alliance for risk assessment	6
Risk assessment of nutrients: There must be a threshold for their effects	6
Letter to the editor regarding “A systematic review of adverse health effects associated with oral cadmium exposure”	6
Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety – A proposal for further actions	6
Tiered human health risk assessment of antibacterial quaternary ammonium compounds (QACs) in dishwashing detergents	6
The Decision Tree approach as a strategy for the global phase out of animal testing for acute and local toxicity for chemicals: recommendations from an expert workshop	6
Implications of variability on medical device chemical equivalence assessment	6
MODEXMO: A modular non-dietary exposure assessment approach for pesticides using dose-based dermal absorption prediction	6
Review of air concentrations of pesticides for estimating exposure to vapour in European risk assessments	6
Editorial Board	6
An Overview of Choice of Reference Biological Medicines in Current Turkish Biosimilar Guideline	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
Experiences and initiatives on pharmacokinetic modeling and simulation data analysis: Perspectives from the Brazilian Health Regulatory Agency (ANVISA)	6
Is schedule IV suvorexant an appropriate reference drug of abuse to use in preclinical abuse liability testing in the rat?	6
Analytical chemistry solutions to hazard evaluation of petroleum refining products	6
Subchronic safety assessment of CIGB-500 in beagle dog after repeated daily dose administration over 28 days	6
Editorial Board	5
Animal use and opportunities for reduction in carcinogenicity studies supporting approved new drug applications in the U.S., 2015–2019	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
Acute and sub chronic toxicity studies with herbal pain relieving formula (Rhuleave-K™) in rats	5
The dangerous precedent of silencing government science	5
Response to letter to editor (P.S Coder and J.D Vidal) regarding “Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation- S. Holalagoudar et al., 2025”	5
Use of in vitro metabolism and biokinetics assays to refine predicted in vivo and in vitro internal exposure to the cosmetic ingredient, phenoxyethanol, for use in risk assessment	5
Impurity qualification requirements for drug-linkers related impurities used to generate antibody-drug conjugates	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
Minimizing the risk of ethylene glycol and diethylene glycol poisoning in medications: A regulatory and pharmacopoeial response	5
Quantitative Structure Use Relationships: Highlights from a technical summit meeting	5
Safety assessment of drug impurities for patient safety: A comprehensive review	5
Lack of human-relevant adversity of MOSH retained in tissues: Analysis of adversity and implications for regulatory assessment	5
Next generation risk assessment for skin allergy: Decision making using new approach methodologies	5
Next generation risk assessment of hair dye HC yellow no. 13: Ensuring protection from liver steatogenic effects	5
Editorial Board	5
Biomonitoring Equivalents for ethylene thiourea	5
Endeavours made by trade associations, pharmaceutical companies and regulators in the replacement, reduction and refinement of animal experimentation in safety testing of pharmaceuticals	5