## Details

Original language | English |
---|---|

Title of host publication | Regulatory Toxicology |

Pages | 213-223 |

Number of pages | 11 |

ISBN (electronic) | 9783642353741 |

Publication status | Published - 5 Mar 2014 |

## Abstract

What is specific to the statistics in toxicology, and why not just use textbook statistics? The reason is the aim of regulatory toxicology: “be confident in negative results.” By toxicological studies, one would like to prove the harmlessness of new drugs. By means of the so-called proof-of-safety approach, the false-negative error rate (consumer’s risk) is directly controlled. Unfortunately, in most of the statistical textbooks and publications, the alternative proof of the efficacy of new drugs with the direct control of the false-positive error rate is used, denoted in toxicology as proof of hazard. Therefore, in this chapter, the basics of the falsification principle are presented simplistic. The commonly used proof-of-hazard approach is discussed hereinafter, focusing on testing a dose-related trend. Finally, the proof-of-safety methods for selected study types are explained by means of examples.

## ASJC Scopus subject areas

## Cite this

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**Statistical evaluation methods in toxicology.**/ Hothorn, Ludwig A.

Regulatory Toxicology. 2014. p. 213-223.

Research output: Chapter in book/report/conference proceeding › Contribution to book/anthology › Research › peer review

*Regulatory Toxicology.*pp. 213-223. https://doi.org/10.1007/978-3-642-35374-1_44

*Regulatory Toxicology*(pp. 213-223) https://doi.org/10.1007/978-3-642-35374-1_44

}

TY - CHAP

T1 - Statistical evaluation methods in toxicology

AU - Hothorn, Ludwig A.

PY - 2014/3/5

Y1 - 2014/3/5

N2 - What is specific to the statistics in toxicology, and why not just use textbook statistics? The reason is the aim of regulatory toxicology: “be confident in negative results.” By toxicological studies, one would like to prove the harmlessness of new drugs. By means of the so-called proof-of-safety approach, the false-negative error rate (consumer’s risk) is directly controlled. Unfortunately, in most of the statistical textbooks and publications, the alternative proof of the efficacy of new drugs with the direct control of the false-positive error rate is used, denoted in toxicology as proof of hazard. Therefore, in this chapter, the basics of the falsification principle are presented simplistic. The commonly used proof-of-hazard approach is discussed hereinafter, focusing on testing a dose-related trend. Finally, the proof-of-safety methods for selected study types are explained by means of examples.

AB - What is specific to the statistics in toxicology, and why not just use textbook statistics? The reason is the aim of regulatory toxicology: “be confident in negative results.” By toxicological studies, one would like to prove the harmlessness of new drugs. By means of the so-called proof-of-safety approach, the false-negative error rate (consumer’s risk) is directly controlled. Unfortunately, in most of the statistical textbooks and publications, the alternative proof of the efficacy of new drugs with the direct control of the false-positive error rate is used, denoted in toxicology as proof of hazard. Therefore, in this chapter, the basics of the falsification principle are presented simplistic. The commonly used proof-of-hazard approach is discussed hereinafter, focusing on testing a dose-related trend. Finally, the proof-of-safety methods for selected study types are explained by means of examples.

UR - http://www.scopus.com/inward/record.url?scp=84957089115&partnerID=8YFLogxK

U2 - 10.1007/978-3-642-35374-1_44

DO - 10.1007/978-3-642-35374-1_44

M3 - Contribution to book/anthology

AN - SCOPUS:84957089115

SN - 9783642353734

SP - 213

EP - 223

BT - Regulatory Toxicology

ER -