A phase 1 study to evaluate the safety, pharmacology, and feasibility of continuous infusion nelarabine in patients with relapsed and/or refractory lymphoid malignancies
Sign Up to like & getrecommendations! Published in 2022 at "Cancer"
DOI: 10.1002/cncr.34570
Abstract: Nelarabine is a purine nucleoside analogue prodrug approved for the treatment of relapsed and refractory T‐cell acute lymphoblastic leukemia (R/R T‐ALL) and lymphoblastic lymphoma (T‐LBL). Although effective in R/R T‐ALL, significant neurotoxicity is dose‐limiting and… read more here.
Keywords: pharmacology; study evaluate; relapsed refractory; evaluate safety ... See more keywords
Safety Pharmacology Study Results and their Impact on the Design of First-in-human Trials for Authorised Oncology Therapies
Sign Up to like & getrecommendations! Published in 2018 at "Pharmaceutical Medicine"
DOI: 10.1007/s40290-018-0246-6
Abstract: BackgroundSafety pharmacology studies are conducted to elucidate possible safety risks on cardiovascular (CV), central nervous system (CNS) and respiratory systems, and are usually carried out prior to first-in-human (FIH) trials. These tests are either standalone… read more here.
Keywords: safety pharmacology; study; pharmacology; oncology ... See more keywords
A predictive index of biomarkers for ictogenesis from tier I safety pharmacology testing that may warrant tier II EEG studies.
Sign Up to like & getrecommendations! Published in 2018 at "Journal of pharmacological and toxicological methods"
DOI: 10.1016/j.vascn.2018.05.002
Abstract: Three significant contributions to the field of safety pharmacology were recently published detailing the use of electroencephalography (EEG) by telemetry in a critical role in the successful evaluation of a compound during drug development (1]… read more here.
Keywords: safety pharmacology; safety; tier safety; pharmacology testing ... See more keywords
Novel methods for the assessment of safety pharmacology and toxicology parameters in anesthetized and ventilated dogs receiving inhaled drugs.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmacological and toxicological methods"
DOI: 10.1016/j.vascn.2019.04.004
Abstract: INTRODUCTION For nonclinical drug development, it is optimal if safety pharmacology and toxicology studies are performed in a model that reasonably represents the patient the drug is intended to treat. To simulate prolonged inhalation therapy… read more here.
Keywords: ventilated dogs; safety pharmacology; pharmacology toxicology; pharmacology ... See more keywords
Response of safety pharmacologists to challenges arising from the rapidly evolving changes in the pharmaceutical industry.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmacological and toxicological methods"
DOI: 10.1016/j.vascn.2019.106593
Abstract: This commentary highlights and expands upon the thoughts conveyed in the lecture by Dr. Alan S. Bass, recipient of the 2017 Distinguished Service Award from the Safety Pharmacology Society, given on 27 September 2017 in… read more here.
Keywords: pharmaceutical industry; safety pharmacology; safety; pharmacology ... See more keywords
NOEL and NOAEL: A retrospective analysis of mention in a sample of recently conducted safety pharmacology studies.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmacological and toxicological methods"
DOI: 10.1016/j.vascn.2019.106597
Abstract: INTRODUCTION The concept of characterizing adversity in relation to administered test article dose and/or exposure within toxicology studies has long been considered a normal aspect of the drug safety evaluation enterprise. The typical way this… read more here.
Keywords: pharmacology studies; safety pharmacology; safety; mention ... See more keywords
The application of electrophysiological methods to characterize AMPA receptors in dissociated adult rat and non-human primate cerebellar neurons for use in neuronal safety pharmacology assessments of the central nervous system.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of pharmacological and toxicological methods"
DOI: 10.1016/j.vascn.2020.106883
Abstract: INTRODUCTION Pre-clinically, safety risk assessment of a drug is primarily tested in vivo using functional evaluation of adult animals while the mechanistic etiology of drug-induced CNS adverse effects is often uncharacterized. In vitro electrophysiology may… read more here.
Keywords: adult; non human; safety pharmacology; drug ... See more keywords
INSPIRE: A European training network to Foster research and training in cardiovascular safety pharmacology.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of pharmacological and toxicological methods"
DOI: 10.1016/j.vascn.2020.106889
Abstract: Safety pharmacology is an essential part of drug development aiming to identify, evaluate and investigate undesirable pharmacodynamic properties of a drug primarily prior to clinical trials. In particular, cardiovascular adverse drug reactions (ADR) have halted… read more here.
Keywords: research; safety pharmacology; safety; training ... See more keywords
Core battery safety pharmacology testing - An assessment of its utility in early drug development.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of pharmacological and toxicological methods"
DOI: 10.1016/j.vascn.2021.107055
Abstract: Requirements for safety pharmacology testing have been in place since the issue of initial regulatory guidance over 20 years ago. An evaluation of such testing, supporting first clinical entry of 105 small molecule drug candidates over… read more here.
Keywords: safety pharmacology; core battery; drug; pharmacology testing ... See more keywords
Simultaneous assessment of central nervous and respiratory systems using jacketed telemetry in socially-housed rats: Application of the "3Rs" principles in core battery safety pharmacology studies.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of pharmacological and toxicological methods"
DOI: 10.2139/ssrn.4357844
Abstract: Central nervous (CNS) and respiratory systems are routinely investigated in safety pharmacology core battery studies. For small molecules, the assessment of both vital organ systems is frequently done in rats in two distinct studies. With… read more here.
Keywords: pharmacology; respiratory; core battery; safety pharmacology ... See more keywords