The Safety Pharmacology Society (SPS) conducted an industry survey in 2015 to identify industry practices as they relate to central, peripheral and autonomic nervous system ('CNS') drug safety testing. One hundred fifty-eight (158) participants from Asia (16%), Europe (20%) and North America (56%) responded to the survey. 52% of participants were from pharmaceutical companies (>1000 employees). Oncology (67%) and neurology/psychiatry (66%) were the most frequent target indications pursued by companies followed by inflammation (48%), cardiovascular (43%), metabolic (39%), infectious (37%), orphan (32%) and respiratory (29%) diseases. Seizures (67% of participants), gait abnormalities (67%), tremors (65%), emesis (56%), sedation (52%) and salivation (47%) were the most commonly encountered CNS issues in pre-clinical drug development while headache (65%), emesis/nausea (60%), fatigue (51%) and dizziness (49%) were the most frequent issues encountered in Phase I clinical trials. 54% of respondents reported that a standard battery of tests applied to screen drug candidates was the approach most commonly used to address non-clinical CNS safety testing. A minority (14% of all participants) reported using electroencephalography (EEG) s...Continue Reading
The role of technical, biological and pharmacological factors in the laboratory evaluation of anticonvulsant drugs. III. Pentylenetetrazole seizure models
A timed intravenous pentylenetetrazol infusion seizure model for quantitating the anticonvulsant effect of valproic acid in the rat
Lack of peripheral neuropathy in Beagle dogs after 53 weeks oral administration of thalidomide capsules
Spectrum of effects detected in the rat functional observational battery following oral administration of non-CNS targeted compounds
Protective effect of erythropoietin and its carbamylated derivative in experimental Cisplatin peripheral neurotoxicity
Clinical and electrophysiological features of peripheral neuropathy induced by administration of cisplatin plus paclitaxel-based chemotherapy
Safety pharmacology assessment of central nervous system function in juvenile and adult rats: effects of pharmacological reference compounds
A functional observational battery in non-human primates for regulatory-required neurobehavioral assessments
Video-electroencephalography in conscious non human primate using radiotelemetry and computerized analysis: refinement of a safety pharmacology model
An optimised neurobehavioural observation battery integrated with the assessment of cardiovascular function in the beagle dog
Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries
Value of non-clinical cardiac repolarization assays in supporting the discovery and development of safer medicines
An integrated cardiovascular and neurobehavioural functional assessment in the conscious telemetered cynomolgus monkey
Arrhythmogenic liability screening in cardiovascular safety pharmacology: commonality between non-clinical safety pharmacology and clinical thorough QT (TQT) studies
Correlation and dissociation of electrophysiology and histopathology in the assessment of toxic neuropathy
A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions
The duration of sleep promoting efficacy by dual orexin receptor antagonists is dependent upon receptor occupancy threshold
Abuse liability assessment in preclinical drug development: predictivity of a translational approach for abuse liability testing using methylphenidate in four standardized preclinical study models
2014 global geographic analysis of mortality from ischaemic heart disease by country, age and income: statistics from World Health Organisation and United Nations
Recalibration of nonclinical safety pharmacology assessment to anticipate evolving regulatory expectations
Predicting toxicities in humans by nonclinical safety testing: an update with particular reference to anticancer compounds
Evaluation methods for drug-induced seizure by microelectrode array recording using human iPS cell-derived neurons
Method for MEA Data Analysis of Drug-treated Rat Primary Neurons and Human iPSC-derived Neurons to Evaluate the Risk of Drug-induced Seizures
A Framework Proposal to Follow-Up on Preclinical Convulsive Signals of a New Molecular Entity in First-in-Human Studies Using Electroencephalographic Monitoring
An Industry Survey With Focus on Cardiovascular Safety Pharmacology Study Design and Data Interpretation.
Applicability of hiPSC-Derived Neuronal Cocultures and Rodent Primary Cortical Cultures for In Vitro Seizure Liability Assessment.
Approach to Neurotoxicity using Human iPSC Neurons: Consortium for Safety Assessment using Human iPS Cells
Molecular Profiling of Human Induced Pluripotent Stem Cell-Derived Cells and their Application for Drug Safety Study
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
The search for translational pain outcomes to refine analgesic development: Where did we come from and where are we going?
[Current state of and challenges in in vivo central nervous system evaluation in safety pharmacology studies-Topic overview and initiatives of the Japanese Safety Pharmacology Society].
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