Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B): Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B)

Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Communication

Standard

Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B) : Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B). / Spindler, Per; Van Cauteren, Herman.

Global Approach in Safety Testing: ICH Guidelines Explained: Global Approach in Safety Testing: ICH Guidelines Explained. Vol. 1 1. ed. Springer Publishing Company, 2013. p. 159-174 (AAPS Advances in the Pharmaceutical Sciences Series (Book 5)).

Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Communication

Harvard

Spindler, P & Van Cauteren, H 2013, Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B): Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B). in Global Approach in Safety Testing: ICH Guidelines Explained: Global Approach in Safety Testing: ICH Guidelines Explained. 1 edn, vol. 1, Springer Publishing Company, AAPS Advances in the Pharmaceutical Sciences Series (Book 5), pp. 159-174. <http://www.amazon.ca/Global-Approach-Safety-Testing-Guidelines/dp/1461459494/ref=sr_1_1?s=books&ie=UTF8&qid=1360868592&sr=1-1#!>

APA

Spindler, P., & Van Cauteren, H. (2013). Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B): Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B). In Global Approach in Safety Testing: ICH Guidelines Explained: Global Approach in Safety Testing: ICH Guidelines Explained (1 ed., Vol. 1, pp. 159-174). Springer Publishing Company. AAPS Advances in the Pharmaceutical Sciences Series (Book 5) http://www.amazon.ca/Global-Approach-Safety-Testing-Guidelines/dp/1461459494/ref=sr_1_1?s=books&ie=UTF8&qid=1360868592&sr=1-1#!

Vancouver

Spindler P, Van Cauteren H. Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B): Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B). In Global Approach in Safety Testing: ICH Guidelines Explained: Global Approach in Safety Testing: ICH Guidelines Explained. 1 ed. Vol. 1. Springer Publishing Company. 2013. p. 159-174. (AAPS Advances in the Pharmaceutical Sciences Series (Book 5)).

Author

Spindler, Per ; Van Cauteren, Herman. / Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B) : Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B). Global Approach in Safety Testing: ICH Guidelines Explained: Global Approach in Safety Testing: ICH Guidelines Explained. Vol. 1 1. ed. Springer Publishing Company, 2013. pp. 159-174 (AAPS Advances in the Pharmaceutical Sciences Series (Book 5)).

Bibtex

@inbook{822d7bd37004422ab88390bbeec4eddb,
title = "Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B): Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B)",
abstract = "To support approval of pharmaceuticals for long term use in humans it is required that product safety is supported by acute and chronic toxicity studies in rodents and non-rodents. The duration of acute toxicity studies (S4A) and chronic rodent studies (S4B) were harmonised between the three ICH regions in 1991; whereas the process of harmonising the duration of non-rodent studies was initiated. The US FDA originally required studies of at least 12 months duration, whereas in Japan and EU studies of 6 months duration were considered acceptable as an ICH objective. In this chapter, the background for the ICH S4B guideline regarding the duration of non-rodent repeated dose toxicity studies is explained and lessons learned are discussed. Since the guideline was issued in 1997 changes occurred in e.g. the language of the European legislation, and the requirements for non-clinical studies to support clinical development has progressed within the ICH (M3): we therefore consider options such as prospective evaluation, biomarker-based mechanistic understanding, toxicokinetics and the use of evidence-based medicine to support further joint activities to harmonise the duration of non-rodent toxicity studies at the global level.",
keywords = "Faculty of Health and Medical Sciences, International Conference on Harmonisation of Technical Requirements for Pharmaceuticals, ICH, pharmaceuticals, Drug Discovery, medicine, regulatory science",
author = "Per Spindler and {Van Cauteren}, Herman",
year = "2013",
month = feb,
day = "1",
language = "English",
isbn = "1461459494",
volume = "1",
series = "AAPS Advances in the Pharmaceutical Sciences Series (Book 5)",
pages = "159--174",
booktitle = "Global Approach in Safety Testing: ICH Guidelines Explained",
publisher = "Springer Publishing Company",
edition = "1",

}

RIS

TY - CHAP

T1 - Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B)

T2 - Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B)

AU - Spindler, Per

AU - Van Cauteren, Herman

PY - 2013/2/1

Y1 - 2013/2/1

N2 - To support approval of pharmaceuticals for long term use in humans it is required that product safety is supported by acute and chronic toxicity studies in rodents and non-rodents. The duration of acute toxicity studies (S4A) and chronic rodent studies (S4B) were harmonised between the three ICH regions in 1991; whereas the process of harmonising the duration of non-rodent studies was initiated. The US FDA originally required studies of at least 12 months duration, whereas in Japan and EU studies of 6 months duration were considered acceptable as an ICH objective. In this chapter, the background for the ICH S4B guideline regarding the duration of non-rodent repeated dose toxicity studies is explained and lessons learned are discussed. Since the guideline was issued in 1997 changes occurred in e.g. the language of the European legislation, and the requirements for non-clinical studies to support clinical development has progressed within the ICH (M3): we therefore consider options such as prospective evaluation, biomarker-based mechanistic understanding, toxicokinetics and the use of evidence-based medicine to support further joint activities to harmonise the duration of non-rodent toxicity studies at the global level.

AB - To support approval of pharmaceuticals for long term use in humans it is required that product safety is supported by acute and chronic toxicity studies in rodents and non-rodents. The duration of acute toxicity studies (S4A) and chronic rodent studies (S4B) were harmonised between the three ICH regions in 1991; whereas the process of harmonising the duration of non-rodent studies was initiated. The US FDA originally required studies of at least 12 months duration, whereas in Japan and EU studies of 6 months duration were considered acceptable as an ICH objective. In this chapter, the background for the ICH S4B guideline regarding the duration of non-rodent repeated dose toxicity studies is explained and lessons learned are discussed. Since the guideline was issued in 1997 changes occurred in e.g. the language of the European legislation, and the requirements for non-clinical studies to support clinical development has progressed within the ICH (M3): we therefore consider options such as prospective evaluation, biomarker-based mechanistic understanding, toxicokinetics and the use of evidence-based medicine to support further joint activities to harmonise the duration of non-rodent toxicity studies at the global level.

KW - Faculty of Health and Medical Sciences

KW - International Conference on Harmonisation of Technical Requirements for Pharmaceuticals

KW - ICH

KW - pharmaceuticals

KW - Drug Discovery

KW - medicine

KW - regulatory science

M3 - Book chapter

SN - 1461459494

VL - 1

T3 - AAPS Advances in the Pharmaceutical Sciences Series (Book 5)

SP - 159

EP - 174

BT - Global Approach in Safety Testing: ICH Guidelines Explained

PB - Springer Publishing Company

ER -

ID: 90204573