Details
| Original language | English |
|---|---|
| Title of host publication | Regulatory Toxicology |
| Subtitle of host publication | Volumes 1-2, Second Edition |
| Publisher | Springer International Publishing AG |
| Pages | 273-284 |
| Number of pages | 12 |
| Volume | 1 |
| ISBN (electronic) | 9783030574994 |
| ISBN (print) | 9783030574987 |
| Publication status | Published - 26 Sept 2021 |
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 simplistically. 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 is explained by means of examples.
Keywords
- Proof of hazard, Proof of safety, Significance tests, Statistics
ASJC Scopus subject areas
- Medicine(all)
- General Medicine
- Pharmacology, Toxicology and Pharmaceutics(all)
- General Pharmacology, Toxicology and Pharmaceutics
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Regulatory Toxicology: Volumes 1-2, Second Edition. Vol. 1 Springer International Publishing AG, 2021. p. 273-284.
Research output: Chapter in book/report/conference proceeding › Contribution to book/anthology › Research › peer review
}
TY - CHAP
T1 - Statistical Evaluation Methods in Toxicology
AU - Hothorn, Ludwig A.
N1 - Publisher Copyright: © Springer Nature Switzerland AG 2021.
PY - 2021/9/26
Y1 - 2021/9/26
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 simplistically. 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 is 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 simplistically. 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 is explained by means of examples.
KW - Proof of hazard
KW - Proof of safety
KW - Significance tests
KW - Statistics
UR - http://www.scopus.com/inward/record.url?scp=85160799701&partnerID=8YFLogxK
U2 - 10.1007/978-3-030-57499-4_44
DO - 10.1007/978-3-030-57499-4_44
M3 - Contribution to book/anthology
AN - SCOPUS:85160799701
SN - 9783030574987
VL - 1
SP - 273
EP - 284
BT - Regulatory Toxicology
PB - Springer International Publishing AG
ER -