The need for guidance in antidepressant drug development: Revisiting the role of the forced swim test and tail suspension test.

Autor: Trunnell ER; People for the Ethical Treatment of Animals (PETA) U.S., 1536 16th St. N.W., Washington, DC, 20036, USA. Electronic address: emilyt@peta.org., Baines J; PETA U.K., Society Building, 8 All Saints Street, London, N1 9RL, UK., Farghali S; Physicians Committee for Responsible Medicine, 5100 Wisconsin Ave # 400, Washington, DC, 20016, USA. Electronic address: sfarghali@pcrm.org., Jackson T; New Zealand Anti-Vivisection Society, PO BOX 9387, Tower Junction, Christchurch, 8149, New Zealand. Electronic address: tara@nzavs.org.nz., Jayne K; PETA U.K., Society Building, 8 All Saints Street, London, N1 9RL, UK. Electronic address: kimberleyj@peta.org.uk., Smith R; Animal-Free Science Advocacy, PO Box 15, Fitzroy Vic, 3065, Australia. Electronic address: rachelsmith@animalfreesci.org.au., Stibbe T; PETA Deutschland e.V., Friolzheimer Strasse 3, 70499, Stuttgart, Germany. Electronic address: tinas@peta.de.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Aug; Vol. 151, pp. 105666. Date of Electronic Publication: 2024 Jun 27.
DOI: 10.1016/j.yrtph.2024.105666
Abstrakt: Depressive disorders are one of the most common mental disorders globally and progress in treating these disorders has been hampered, in part, by a lack of suitable nonclinical efficacy tests. Two common tests used in nonclinical efficacy studies of antidepressants-the forced swim test (FST) and tail suspension test (TST)-have come under criticism in recent years for their inconsistency and lack of validity, yet they continue to be used in the pharmaceutical industry. In this review, we provide a rationale for why international pharmaceutical regulatory and guidance agencies should begin issuing direction on methods for non-clinical efficacy testing that traditionally use the FST and TST, particularly considering that some regulators, such as those in the U.S. and E.U., allow the authorization of clinical trials to proceed without requiring tests in animals. The area of antidepressant drug discovery represents an important opportunity for reducing the attrition of psychiatric drugs, harmonizing regulatory requirements, and reducing animal use. Specific recommendations for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have been provided.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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