The influence of the rate of administration was examined during the test "Abnormal toxicity" on the quality control of ceftriaxone in a comparative experimental study on the basis of the methodologies Rus. Ph. XII and Eur. Ph. Recommendations are issued for conducting study entitled "Abnormal toxicity" for the formulations of ceftriaxone.
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Toxicol Rep
December 2024
National Institute of Biologicals, Ministry of Health and Family Welfare, Noida, Uttar Pradesh 201309, India.
Abnormal Toxicity Test (ATT) is performed as quality control test by manufacturers and National Control Laboratory (NCL) to ensure safety of biologicals. However, stakeholders are in general consensus that extraneous toxic contaminations are extremely unlikely where Good Manufacturing Practices (GMPs) and consistent production have been established. This test requiring mice and guinea pigs is still a regulatory requirement for the batch release of biologicals in several countries although it has been deleted by some National Regulatory Authorities (NRAs) and Pharmacopoeias while some are still working on its elimination.
View Article and Find Full Text PDFRes Vet Sci
November 2024
National Reference Center for Alternative Methods, Welfare and Care of Laboratory Animals, Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia-Romagna-IZSLER, Via Bianchi 9, 25124 Brescia, Italy. Electronic address:
The Abnormal Toxicity Test (ATT) is an in vivo assay traditionally used in the autogenous vaccine release. That test, commonly applied to verify vaccine quality, is subject to ethical and practical limitations and should be removed as reference methods. This approach is necessary to update the regulatory framework and to apply the 3Rs principle in the pharmaceutical field.
View Article and Find Full Text PDFPLoS One
October 2024
ALPS Medical Centre, ALPS Global Holding, Kuala Lumpur, Malaysia.
Objective: Human umbilical cord mesenchymal stem cells (hUCMSCs) hold significant promise across various clinical applications. Therefore, regulatory requirements necessitate a thorough investigation of the hUCMSCs safety before clinical trials and potential allergic reactions after transplantation.
Methods: Abnormal toxicity test employed mice and guinea pigs dosed daily at 0.
Regul Toxicol Pharmacol
September 2024
Novo Nordisk AS, Malov, Denmark.
Following the European Commission decision to develop a roadmap to phase out animal testing and the signing of the US Modernisation Act, there is additional pressure on regulators and the pharmaceutical industry to abandon animal experimentation in safety testing. Often, endeavours already made by governments, regulators, trade associations, and industry to replace, reduce and refine animal experimentation (3Rs) are unnoticed. Herein, we review such endeavours to promote wider application and acceptance of 3Rs.
View Article and Find Full Text PDFRegul Toxicol Pharmacol
May 2024
Preclinical Sciences and Translational Safety, Janssen (China) Research & Development, China.
Accumulating evidence has shown that the abnormal toxicity test (ATT) is not suitable as a quality control batch release test for biologics and vaccines. The purpose of the current study was to explore the optimal ATT experimental design for an adenoviral vector-based vaccine product to avoid false positive results following the standard test conditions stipulated in the Pharmacopoeias. ATT were conducted in both mice and guinea pigs based on methods in Pharmacopeias, with modifications to assess effects of dose volume and amount of virus particles (VPs).
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