Zobrazeno 1 - 10
of 31
pro vyhledávání: '"Zachary J. Zimmermann"'
Autor:
Zachary J. Zimmermann, David V. Gauvin
Publikováno v:
Current Opinion in Toxicology. 28:20-31
There have been remarkable advances in the early identification of behavioral changes predictive of neurotoxicity induced by xenobiotic administrations in laboratory animals during Tier I safety testing. By definition, this risk assessment is conduct
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::66bf62c55385a4ce0c24cfb1319da509
https://doi.org/10.1016/j.cotox.2021.09.001
https://doi.org/10.1016/j.cotox.2021.09.001
Distortion Product Otoacoustic Emission Test is Not the Test to Use in Nonclinical Safety Assessment
Publikováno v:
International journal of toxicology. 41(3)
Ototoxicity and ocular toxicity screening are but two examples of specialty product lines that are often employed as Tier II or III nonclinical safety/hazard screening assessments. Compared to the regulatory guidelines that govern over standard toxic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8803b88073130ed7d2276ff754d38349
https://pubmed.ncbi.nlm.nih.gov/35443823
https://pubmed.ncbi.nlm.nih.gov/35443823
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 129
Derisking is not a pharmaceutical industry strategy to reduce time, effort, or costs in drug development. Derisking strategies originated within the National Institutes of Health as a predicate to good science. There is a growing sentiment within dru
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c4f27b301d43eedda3cde3a6abefcc5f
https://pubmed.ncbi.nlm.nih.gov/35017023
https://pubmed.ncbi.nlm.nih.gov/35017023
Publikováno v:
Regulatory Toxicology and Pharmacology. 101:103-120
Risk assessment is not a choice. Drug Abuse Liability (DAL) is mandated under international and national drug control statutes for all drugs targeting the CNS. Once administered to humans many biologics may have long-lived or permanent physiological
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d90c88d1aa73c98dc902f2bb95bffd1c
https://doi.org/10.1016/j.yrtph.2018.11.009
https://doi.org/10.1016/j.yrtph.2018.11.009
Autor:
Zachary J. Zimmermann, David V. Gauvin
Publikováno v:
Journal of pharmacological and toxicological methods. 111
This “methods paper” focusses on one specific and limited aspect of drug safety evaluations required for all new drug entities that affect the central nervous system – the drug discrimination (DD) assay. We focus on three critical factors invol
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d657552226b827ce3c753877c30ef6ed
https://pubmed.ncbi.nlm.nih.gov/33965568
https://pubmed.ncbi.nlm.nih.gov/33965568
Publikováno v:
International Journal of Toxicology. 37:422-433
Spontaneous unexpected events occasionally develop during the course of rodent preclinical toxicology studies. The presentation of serious adverse events on animal studies may require notification of these events to the Food and Drug Administration i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3337bfb95a01d0dea7ab05fce286a655
https://doi.org/10.1177/1091581818796444
https://doi.org/10.1177/1091581818796444
Publikováno v:
Journal of Pharmacological and Toxicological Methods. 88:123-129
There are three major assays that must be conducted in standard investigational new drug (IND) -enabling ototoxicity study designs: 1) functional acoustic threshold measurements (Auditory Brainstem Respsonse, ABR); 2) otohistopathology and 3) cytococ
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::58bd3b0510a0a137672b449ac6320134
https://doi.org/10.1016/j.vascn.2017.09.254
https://doi.org/10.1016/j.vascn.2017.09.254
Publikováno v:
The Psychological Record. 67:559-567
Levamisole (LVM) is often added to illicit cocaine, but the reason for this is unclear. Previous research indicated that LVM sometimes increases the rewarding effects of cocaine, as measured by conditioned place preference. The present study examined
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::940ee5ebe3da57079a3c114ff125b7e2
https://doi.org/10.1007/s40732-017-0260-1
https://doi.org/10.1007/s40732-017-0260-1
Publikováno v:
Journal of Pharmacological and Toxicological Methods. 86:44-59
All new molecular entities that enter the CNS and exert an activity in the brain must be assessed for abuse liability prior to a New Drug Application approval by the US Food and Drug Administration. One element of the screening process is the assessm
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b2a71532c3f867a8af03aa289192c741
https://doi.org/10.1016/j.vascn.2017.03.002
https://doi.org/10.1016/j.vascn.2017.03.002
Autor:
Mary-Jeanne Kallman, Jill A. Dalton, Theodore J. Baird, Zachary J. Zimmermann, David V. Gauvin
Publikováno v:
International journal of toxicology. 38(5)
In the adoption of behavior as a critical end point in safety pharmacology and neurotoxicity screening, federal regulatory agencies have shifted the predominating scientific perspective from pharmacology back to the experimental analysis of behavior
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2f2dc75aa79f34f25edff970cd887ae6
https://pubmed.ncbi.nlm.nih.gov/31470748
https://pubmed.ncbi.nlm.nih.gov/31470748