Using historical control data in bioassays for regulatory toxicology

Expanding the toxicologist's statistical toolbox: Using effect size estimation and dose-response modelling for holistic assessments instead of generic testing

(2021) Felix M. Kluxen et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Alternatives to statistical decision trees in regulatory (eco-)toxicological bioassays

(2020) Felix M. Kluxen et al.   ARCHIVES OF TOXICOLOGY

A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG)

(2020) Mercedeh Ghadessi et al.   Orphanet Journal of Rare Diseases

Accounting for Multiple Comparisons in Statistical Analysis of the Extensive Bioassay Data on Glyphosate

(2020) Kenny Crump et al.   TOXICOLOGICAL SCIENCES

Correcting for Multiple Comparisons in Statistical Analysis of Animal Bioassay Data

(2020) Kenny Crump et al.   TOXICOLOGICAL SCIENCES

Questioning existing cancer hazard evaluation standards in the name of statistics

(2020) Ivan Rusyn et al.   TOXICOLOGICAL SCIENCES

Use of the kinetically-derived maximum dose concept in selection of top doses for toxicity studies hampers proper hazard assessment and risk management

(2020) Minne B. Heringa et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

“New statistics” in regulatory toxicology?

(2020) Felix M. Kluxen   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Evaluation of the Inherent Toxicity Concept in Environmental Toxicology and Risk Assessment

(2020) L.S. McCarty et al.   ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY

Letter to the editors regarding Heringa et al. (2020)

(2020) Carr J. Smith et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Use compatibility intervals in regulatory toxicology

(2020) Ludwig A. Hothorn et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Scientists rise up against statistical significance

(2019) Valentin Amrhein et al.   NATURE

Moving to a World Beyond “p 

(2019) Ronald L. Wasserstein et al.   AMERICAN STATISTICIAN

Before p 

(2019) Lee Kennedy-Shaffer   AMERICAN STATISTICIAN

Incorporating individual historical controls and aggregate treatment effect estimates into a Bayesian survival trial: a simulation study

(2019) Caroline Brard et al.   BMC Medical Research Methodology

A Review of Recent Advances in Benchmark Dose Methodology

(2019) Signe M. Jensen et al.   RISK ANALYSIS

Scatter plotting as a simple tool to analyse relative organ to body weight in toxicological bioassays

(2019) Felix M. Kluxen   ARCHIVES OF TOXICOLOGY

A critical evaluation of thyroid hormone measurements in OECD test guideline studies: Is there any added value?

(2019) Manon Beekhuijzen et al.   REPRODUCTIVE TOXICOLOGY

Recommended criteria for the evaluation of bacterial mutagenicity data (Ames test)

(2019) Dan D. Levy et al.   MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS

Are confidence intervals better termed “uncertainty intervals”?

(2019) Andrew Gelman et al.   BMJ-British Medical Journal

Reveal, Don’t Conceal

(2019) Tracey L. Weissgerber et al.   CIRCULATION

The Use and Misuse of Historical Controls in Regulatory Toxicology: Lessons from the CLARITY-BPA Study

(2019) Laura N Vandenberg et al.   ENDOCRINOLOGY

Going to extremes: the Goldilocks/Lagom principle and data distribution

(2019) Henry J Leese et al.   BMJ Open

Toxicity testing in the 21st century: progress in the past decade and future perspectives

(2019) D. Krewski et al.   ARCHIVES OF TOXICOLOGY

The rat bone marrow micronucleus test: Statistical considerations on historical negative control data

(2018) Bernd-Wolfgang Igl et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Differences in Types and Incidence of Neoplasms in Wistar Han and Sprague-Dawley Rats

(2017) Klaus Weber   TOXICOLOGIC PATHOLOGY

A general theory of effect size, and its consequences for defining the benchmark response (BMR) for continuous endpoints

(2016) Wout Slob   CRITICAL REVIEWS IN TOXICOLOGY

Is It Adverse, Nonadverse, Adaptive, or Artifact?

(2016) Arun R. Pandiri et al.   TOXICOLOGIC PATHOLOGY

Boxplots for grouped and clustered data in toxicology

(2015) Philip Pallmann et al.   ARCHIVES OF TOXICOLOGY

Reducing sample size in experiments with animals: historical controls and related strategies

(2015) Matthew Kramer et al.   BIOLOGICAL REVIEWS

Transparency Is the Key to Quality

(2015) Amanda J. Fosang et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Statistical approaches for the determination of cut points in anti-drug antibody bioassays

(2015) Frank Schaarschmidt et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Fitting Linear Mixed-Effects Models Usinglme4

(2015) Douglas Bates et al.   Journal of Statistical Software

tolerance: AnRPackage for Estimating Tolerance Intervals

(2015) Derek S. Young   Journal of Statistical Software

Kick the bar chart habit

(2014)   NATURE METHODS

Statistical evaluation of toxicological bioassays – a review

(2014) Ludwig A. Hothorn   Toxicology Research

Use of historical control data for assessing treatment effects in clinical trials

(2013) Kert Viele et al.   PHARMACEUTICAL STATISTICS

A comparison of three methods for integrating historical information for Bayesian model averaged benchmark dose estimation

(2012) Kan Shao   ENVIRONMENTAL TOXICOLOGY AND PHARMACOLOGY

Equivalence tests – A review

(2012) Michael Meyners   FOOD QUALITY AND PREFERENCE

A new perspective on the Dunnett procedure: Filling the gap between NOEC/LOEC and ECx concepts

(2011) Marie-Laure Delignette-Muller et al.   ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY

Differences in Rat Models Used in Routine Toxicity Studies

(2011) Klaus Weber et al.   INTERNATIONAL JOURNAL OF TOXICOLOGY

Statistical considerations for calculation of immunogenicity screening assay cut points

(2011) David Hoffman et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Compilation and use of genetic toxicity historical control data

(2010) Makoto Hayashi et al.   MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS

Statistical evaluation of the Local Lymph Node Assay

(2009) Ludwig A. Hothorn et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions

(2009) Charlotte Keenan et al.   TOXICOLOGIC PATHOLOGY

Proof of Hazard and Proof of Safety in Toxicological Studies Using Simultaneous Confidence Intervals for Differences and Ratios to Control

(2008) Ludwig A. Hothorn et al.   Journal of Biopharmaceutical Statistics

Variability in Weight and Histological Appearance of the Prostate of Beagle Dogs Used in Toxicology Studies

(2008) Laëtitia Dorso et al.   TOXICOLOGIC PATHOLOGY