Regulatory Toxicology and Pharmacology

Papers
(The median citation count of Regulatory Toxicology and Pharmacology is 3. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2021-05-01 to 2025-05-01.)
ArticleCitations
Perspectives on the elimination of animal assays in the assessment of carcinogenicity197
Evaluation of the OECD QSAR toolbox automatic workflow for the prediction of the acute toxicity of organic chemicals to fathead minnow80
Safety evaluation of ondansetron after gestational exposure on male reproductive parameters in rats68
Ames mutagenicity of 15 aryl, benzyl, and aliphatic ring N-nitrosamines64
Target organ toxicity in Sprague Dawley rats following oral exposure to complex groundwater mixture: Assessment of dose-response relationships using histopathological and biochemical alterations62
Qualitative analysis of actual Standard for Exchange of Nonclinical Data (SEND) datasets for Data Domains: Proposition from Japan Pharmaceutical Manufacturers Association SEND Taskforce Team on standa60
Comprehensive investigation evaluating the carcinogenic hazard potential of acetaminophen56
Ability of mathematical models to predict human in vivo percutaneous penetration of steroids52
Selectively addressing total risk avoidance for certain chemicals while overlooking others: The case of per-and-poly-fluoroalkyls50
Preclinical safety evaluation of the ethanolic extract from the aerial parts of Gomphrena celosioides Mart. in rodents49
Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy46
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes43
Assessing biological oxidative damage induced by graphene-based materials: An asset for grouping approaches using the FRAS assay43
Is periventricular heterotopia a useful endpoint for developmental thyroid hormone system disruption in mouse toxicity studies?38
Twenty six-week repeat dose oral rat toxicity study of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator38
Two-year carcinogenicity study of a novel plasticizer, bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), by oral diet in Han Wistar rats38
Nonclinical safety assessment of engineered T cell therapies37
A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol37
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)37
HESI GTTC Ring Trial: Concordance between Ames and Rodent Carcinogenicity Outcomes for N-Nitrosamines (NAs) with Rat and Hamster Metabolic Conditions37
Exploring the potential of ToxCast™ data for mechanism-based prioritization of chemicals in regulatory context: Case study with priority existing chemicals (PECs) under K-REACH36
Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer34
Derivation of an occupational exposure limit for β-glucans33
Editorial Board31
Editorial Board28
False positive findings associated with adenoviral vector-based vaccine underscore the regulatory necessity to eliminate abnormal toxicity test28
Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review28
Decision making in next generation risk assessment for skin allergy: Using historical clinical experience to benchmark risk27
Subchronic oral toxicity study of rhubarb extract in Sprague-Dawley rats27
The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/2126
Editorial: 2024 - A promising start for regulatory toxicology and pharmacology26
Importance of tailored non-clinical safety testing of novel antimalarial drugs: Industry best-practice25
Incorporating Singaporean habits and practices for cosmetics and personal care products into a global consumer aggregate exposure model25
The Dilemma of perfluorooctanoate (PFOA) human half-life25
Results from two-year rodent oral carcinogenicity studies of cizolirtine, a substance-P and calcitonin gene-related peptide release modulator25
Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan24
Safety data sheets as an information pathway on hazards of occupationally used cleaning agents24
Acute dose toxicity evaluation of the food supplement calcium 3-hydroxy-3-methylbutyrate (HMB) in female Sprague Dawley rats24
Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals23
Nonclinical evaluation of abuse liability of the dual orexin receptor antagonist lemborexant23
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 d23
Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice23
Threshold of Toxicological Concern: Extending the chemical space by inclusion of a highly curated dataset for organosilicon compounds22
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop21
Chemical interactions and mixtures in public health risk assessment: An analysis of ATSDR's interaction profile database21
Human exposure to toxic elements through facial cosmetic products: Dermal risk assessment21
Case study on the impact of the source of metabolism parameters in next generation physiologically based pharmacokinetic models: Implications for occupational exposures to trimethylbenzenes20
Subchronic toxicity study of ferric oxide nanoparticles through intragastric administration: A 94-d, repeated dose study in Sprague Dawley rats20
Evaluating H295R steroidogenesis assay data for robust interpretation20
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments20
Computational prediction of Calu-3-based in vitro pulmonary permeability of chemicals20
Mapping new psychoactive substances: Leveraging GIS technology for advanced global surveillance and policy support20
Editorial Board18
Safety evaluation of recycling process used to produce recycled pulp for adult paper diapers18
Letter to the editors regarding “Inter-laboratory validation of bioaccessibility testing for metals” by Henderson et al. (2014)18
Effects of glucokinase activator, DS-7309, on embryo-fetal developmental toxicity in rats and rabbits18
Editorial Board18
Disease area and mode of action as criteria to assign a default occupational exposure limit18
Measured air concentrations of pesticides for the estimation of exposure to vapour in European risk assessments18
Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients17
Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC)17
Prioritizing of potential environmental exposure carcinogens beyond IARC group 1–2B based on weight of evidence (WoE) approach17
Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel16
The purity of tattoo inks, screening substances of high concern16
Letter to the Editors regarding “10% body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis”15
Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults15
Modeling extraction of medical device polymers for biocompatibility evaluation15
Calculated cancer risks for polycyclic aromatic hydrocarbon mixtures in mainstream smoke of cigarettes sold in China15
Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate15
Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats15
Non-animal approaches for photoallergenicity safety assessment: Needs and perspectives for the toxicology for the 21st century15
Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7)14
A systematic approach to evaluate plausible modes of actions for mouse lung tumors in mice exposed to 4-methylimidozole14
A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model14
Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost14
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 genes14
Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure14
Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection14
Rodent estrous cycle pattern: Harmonizing the cycle evaluation and interpretation14
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 se14
Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment14
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays14
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 rats14
A comprehensive review of mechanistic insights into formaldehyde-induced nasal cavity carcinogenicity14
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-glufosinate13
Quantitative measurement of harmful and potentially harmful constituents, pH, and moisture content in 16 commercial smokeless tobacco products13
N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP13
Residue depletion profiles and withdrawal interval estimations of meloxicam in eggs and ovarian follicles following intravenous (Meloxicam solution for injection) and oral (Meloxidyl®) administration 13
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 w13
Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories13
Six-well plate-based colony-forming efficacy assay and Co-Culture application to assess toxicity of metal oxide nanoparticles12
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States12
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”12
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 Baskett12
The Botanical Safety Consortium: A public-private partnership to enhance the botanical safety toolkit12
Carcinogenicity testing in drug development: Getting it right12
Cancer weight of evidence for three lower acrylates: Conclusions and recommendations from an expert panel12
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products12
Absence of developmental or reproductive toxicity in rats for MB-102, a fluorescent tracer agent for point-of-care measurement of glomerular filtration rate12
Exploring the link: DNA methylation and kidney injury markers in farmers exposed to glyphosate-surfactant herbicides12
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening12
Inter-laboratory performance of ICE histopathology scoring to identify UN GHS Category 1 surfactants and non-extreme pH detergents11
Systematic review of the potential carcinogenicity of bisphenol A in humans11
Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants11
In silico predictions of absorption of MDI substances after dermal or inhalation exposures to support a category based read-across assessment11
Editorial Board11
Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database11
Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals11
R-ODAF: Omics data analysis framework for regulatory application11
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey11
Re: A call for action on the development and implementation of new methodologies for safety assessment of chemical-based products in the EU – A short communication11
Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits11
A scheme to evaluate structural alerts to predict toxicity – Assessing confidence by characterising uncertainties11
Refinement of decision tree to assess the consequences of increased serum ALP in dogs: Additional analysis on toxicity studies of pesticides evaluated recently in Japan11
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]11
Nicotine dosimetry and stability in cambridge filter PADs (CFPs) following different smoking regime protocols and storage conditions11
Comprehensive analysis of chronic rodent inhalation toxicity studies for methyl acrylate with attention to test conditions exceeding a maximum tolerated concentration11
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 r10
Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage10
Classes of organic pigments meet tentative PSLT criteria and lack toxicity in short-term inhalation studies10
Historical control data of rare events: Issues, chronological patterns and their relevance for toxicological evaluations10
Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds10
Extended One-Generation Reproductive Toxicity (EOGRT) study of benzoic acid in Sprague Dawley rats10
SCCS scientific opinion on Butylated hydroxytoluene (BHT) - SCCS/1636/2110
Retraction notice to “Proof of concept efficacy study of intranasal stabilized isoamyl nitrite (SIAN) in Rhesus monkeys against acute cyanide poisoning” [Regul. Toxicol. Pharmacol. 123 (2021) 104927]10
Evaluating dermal absorption of perfluorooctanoic acid (PFOA) and implications for other per- and polyfluoroalkyl substances (PFAS)10
Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese10
Toxicity reference values for force health protection: Provisional occupational exposure guidelines10
The utility of hERG channel inhibition data in the derivation of occupational exposure limits10
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice10
Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis9
Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK215429
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 4979
Editorial Board9
Developing a database of systematic reviews of animal studies9
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology9
Propylene glycol, skin sensitisation and allergic contact dermatitis: A scientific and regulatory conundrum9
Application of a new approach method (NAM) for inhalation risk assessment9
Physiologically based pharmacokinetic (PBPK) modeling of perfluorohexane sulfonate (PFHxS) in humans9
Estimating uncertainty in LLNA EC3 data and its impact on regulatory classifications9
Editorial Board9
Inhalation cancer risk assessment for environmental exposure to hexavalent chromium: Comparison of margin-of-exposure and linear extrapolation approaches9
Development of COVID-19 therapies: Nonclinical testing considerations9
Three-tiered approach for standard information requirements for polymers requiring registration under REACH9
Gamma-hydroxybutyrate (GHB), 1,4-butanediol (1,4BD), and gamma-butyrolactone (GBL) intoxication: A state-of-the-art review9
A new approach methodology using kinetically-derived maximum dose levels in risk assessment – A case study with afidopyropen9
Amphibian Metamorphosis Assay: Investigation of the potential effects of five chemicals on the hypothalamic-pituitary thyroid axis of Xenopus laevis9
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
Effects of as-if risk framing of hazards on risk perception and its rebuttal9
Derivation of Biomonitoring Equivalents for aluminium for the interpretation of population-level biomonitoring data9
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration9
Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes8
10% Body weight (gain) change as criterion for the maximum tolerated dose: A critical analysis8
GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations8
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies8
A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects8
Evaluation of the safety of ethanolic extract from Piper amalago L. (Piperaceae) leaves in vivo: Subacute toxicity and genotoxicity studies8
Safety evaluation of food enzymes produced by a safe strain lineage of Bacillus subtilis8
Long-term e-cigarette aerosol exposure causes pulmonary emphysema in adult female and male mice8
Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens8
A scoping review of infant and children health effects associated with cadmium exposure8
Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia8
Safety assessment of MPTA: An oral acute and 90-day sub-chronic toxicity study in Sprague-Dawley rats8
Health safety of parabens evaluated by selected in vitro methods8
A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment8
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 test8
The new paradigm in animal testing – “3Rs alternatives”8
A 90-day subchronic toxicity study of Myrrh in F344 rats7
A reproductive and developmental toxicity screening study of 1,3-butadiene in Sprague-Dawley rats7
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 p7
Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 4327
Response to letter to editor “letter to the editors regarding “the Conundrum of the PFOA human half-life, an international collaboration.”7
Comparison of toxicological effects and exposure levels between triclosan and its structurally similar chemicals using in vitro tests for read-across case study7
REACHing for solutions: Essential revisions to the EU chemicals regulation to modernise safety assessment7
Afidopyropen: Challenges and impact of a toxicokinetic study designed to identify a point of inflection from dose-proportionality7
A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals7
What happened to quinacrine non-surgical female sterilization?7
Quantitative risk assessment of allergens leaching from menstrual hygiene products7
Editorial Board7
Challenges in the classification of chemical respiratory allergens based on human data: Case studies of 2-hydroxyethylmethacrylate (HEMA) and 2-hydroxypropylmethacrylate (HPMA)7
Statistical applications of virtual control groups to nonrodent animal toxicity studies: An initial evaluation7
The safety of a Kluyveromyces lactis strain lineage for enzyme production7
Best practices for exposure model peer review – A SciPinion advisory panel report7
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials7
Liver biomarkers in adults: Evaluation of associations with reported green tea consumption and use of green tea supplements in U.S. NHANES7
Harmonized 3Rs-based non-mutagenic impurity qualification study designs developed using the results of an IQ consortium survey7
Adeno-associated virus (AAV)-based gene therapy products: What are toxicity studies in non-human primates showing us?7
Letter to the editors regarding “Risk assessments for the insect repellents DEET and picaridin”6
How sensitive does chemical characterization of medical devices need to be? Calibration of analytical evaluation thresholds with the carcinogenic potency database6
Model systems and organisms for addressing inter- and intra-species variability in risk assessment6
Exposure considerations in human safety assessment: Report from an EPAA Partners’ Forum6
Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA)6
Safe- and sustainable-by-design: The case of Smart Nanomaterials. A perspective based on a European workshop6
Calculating qualified non-mutagenic impurity levels: Harmonization of approaches6
Letter to the editor regarding “A systematic review of adverse health effects associated with oral cadmium exposure”6
Derivation of subacute guidance values for chemical contaminants of drinking water quality standard in Japan6
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines6
Preclinical safety assessment of JNJ-10450232 (NTM-006), a structural analog of acetaminophen, that does not cause hepatotoxicity at supratherapeutic doses6
Expansion of the Cosmetics Europe skin sensitisation database with new substances and PPRA data6
Biomonitoring Equivalents for N,N-Diethyl-meta-toluamide (DEET)6
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 6
Experiences and initiatives on pharmacokinetic modeling and simulation data analysis: Perspectives from the Brazilian Health Regulatory Agency (ANVISA)6
Risk assessment of nutrients: There must be a threshold for their effects6
In vivo alkaline comet assay: Statistical considerations on historical negative and positive control data6
Recommendation for an occupational exposure limit for toluene6
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-butadiene6
Fluoride concentrations in drinking water and health risk assessment in the south of Algeria6
Comparison of carbonyls and tobacco-specific nitrosamines in aerosols of heated tobacco products and conventional cigarette smoke using both targeted and untargeted analytical methods6
Systematic update to the mammalian relative potency estimate database and development of best estimate toxic equivalency factors for dioxin-like compounds6
Mode of action Criteria for selection of the critical effect and safe dose range for PFOA by the Alliance for risk assessment6
Curing of UV prints – Assessment of possible toxicological hazard for consumers5
A 10-step framework for use of read-across (RAX) in next generation risk assessment (NGRA) for cosmetics safety assessment5
Formation and evaluation of mechanism-based chemical categories for regulatory read-across assessment of repeated-dose toxicity: A case of hemolytic anemia5
Review of air concentrations of pesticides for estimating exposure to vapour in European risk assessments5
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 da5
SCCS scientific opinion on HAA299 (nano) - SCCS/1634/215
Experimental study for the establishment of a chemotherapy-induced ovarian insufficiency model in rats by using cyclophosphamide combined with busulfan5
Semiquantitative sensitization safety assessment of extractable and leachables associated with parenteral pharmaceutical products5
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 anthroposophic5
Subchronic safety assessment of CIGB-500 in beagle dog after repeated daily dose administration over 28 days5
The role of trust in the use of artificial intelligence for chemical risk assessment5
Monosodium glutamate in a type 2 diabetes context: A large scoping review5
Application of physiologically-based pharmacokinetic modeled toluene blood concentration in the assessment of short term exposure limits5
Monitoring and risk assessment of hazardous chemicals in toy-slime and putty in the Netherlands5
Comparison of PAC and MOAH for understanding the carcinogenic and developmental toxicity potential of mineral oils5
Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety – A proposal for further actions5
Implications of variability on medical device chemical equivalence assessment5
Editorial Board5
Regulatory safety pharmacology and toxicity assessments of a standardized stem extract of Cassia occidentalis Linn. in rodents5
Classification of chemicals as respiratory allergens based on human data: Requirements and practical considerations5
Safety assessment of phytase transgenic maize 11TPY050 in Sprague-Dawley rats by 90-day feeding study5
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 Arabia5
Editorial: Looking back and forward5
Is schedule IV suvorexant an appropriate reference drug of abuse to use in preclinical abuse liability testing in the rat?5
Can “Hazard-Cost-Effectiveness Analysis” improve the risk management of chemicals under REACH?5
An Overview of Choice of Reference Biological Medicines in Current Turkish Biosimilar Guideline5
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 an5
The need for guidance in antidepressant drug development: Revisiting the role of the forced swim test and tail suspension test5
Editorial Board5
Editorial Board5
Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?5
2000–2023 over two decades of ICH S7A: has the time come for a revamp?5
Probabilistic pharmacokinetic modeling of airborne lead corresponding to toxicologically relevant blood lead levels in workers5
A new paradigm for regulatory sciences5
Analytical chemistry solutions to hazard evaluation of petroleum refining products5
A toxicological evaluation for safety assessment of ruthenium-based diosmetin complex in rats5
Letter to the editors regarding “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 Agency5
Re-evaluation of the reduced heart weights in male rats in a 28-day oral repeated-dose toxicity study of tetramethylammonium hydroxide5
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