Comparative Regulatory Testing Requirements

Comparative Regulatory Testing Requirements Publisher

Mousavi T^{1, 2} ; Abdollahi M^{1, 2}

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1. Toxicology and Diseases Group (TDG), Pharmaceutical Sciences Research Center (PSRC), The Institute of Pharmaceutical Sciences (TIPS), Tehran, Iran
2. Department of Toxicology and Pharmacology, Faculty of Pharmacy, Tehran University of Medical Sciences (TUMS), Tehran, Iran

Source: Encyclopedia of Toxicology# Fourth Edition: Volume 1-9 Published:2023

Abstract

Since the first cases of thalidomide-induced birth defects and chloramphenicol-induced aplastic anemia, there have been significant improvements in the overall toxicity assessment of products. However, adverse drug events (ADEs) still contribute to many hospitalizations and deaths worldwide, which might be due to administration, formulation or safety issues in different development steps from the preclinical stage to post-marketing surveillance. This is where the role of regulators becomes prominent, and imposing necessary legislation seems vital. Through reviewing global and national guidelines, you will get acquainted with the toxicity requirements in preclinical and clinical settings in this chapter. Besides, you will understand how essential international regulators differ in legislating medications, biologics, foods, cosmetics, medical devices, animal and veterinary products, considering the safety aspect. © 2024 Elsevier Inc. All rights reserved.

Style	Citing Format
MLA	Mousavi T, Abdollahi M. "Comparative Regulatory Testing Requirements." Encyclopedia of Toxicology# Fourth Edition: Volume 1-9, vol. 3, no. , 2023, pp. V3-205.
APA	Mousavi T, Abdollahi M (2023). Comparative Regulatory Testing Requirements. Encyclopedia of Toxicology# Fourth Edition: Volume 1-9, 3(), V3-205.
Chicago	Mousavi T, Abdollahi M. "Comparative Regulatory Testing Requirements." Encyclopedia of Toxicology# Fourth Edition: Volume 1-9 3, no. (2023): V3-205.
Harvard	Mousavi T, Abdollahi M (2023) 'Comparative Regulatory Testing Requirements', Encyclopedia of Toxicology# Fourth Edition: Volume 1-9, 3(), pp. V3-205.
Vancouver	Mousavi T, Abdollahi M. Comparative Regulatory Testing Requirements. Encyclopedia of Toxicology# Fourth Edition: Volume 1-9. 2023;3():V3-205.
BibTex	@article{ author = {Mousavi T and Abdollahi M}, title = {Comparative Regulatory Testing Requirements}, journal = {Encyclopedia of Toxicology# Fourth Edition: Volume 1-9}, volume = {3}, number = {}, pages = {V3-205}, year = {2023} }
RIS	TY - JOUR AU - Mousavi T AU - Abdollahi M TI - Comparative Regulatory Testing Requirements JO - Encyclopedia of Toxicology# Fourth Edition: Volume 1-9 VL - 3 IS - SP - V3 EP - 205 PY - 2023 ER -

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Abstract