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Advanced Issue Resolution in Safety Pharmacology

1, 2018

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Safety pharmacology investigations on the nervous system: An industry survey

Journal of pharmacological and toxicological methods, 2016-09, Vol.81, p.37-46

2016

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EEG in non-clinical drug safety assessments: Current and emerging considerations

Journal of pharmacological and toxicological methods, 2016-09, Vol.81, p.274-285

2016

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CNS Safety Screening Under ICH S7A Guidelines Requires Observations of Multiple Behavioral Units to Assess Motor Function

International Journal of Toxicology, 2019-09, Vol.38 (5), p.339-356

2019

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An Industry Survey With Focus on Cardiovascular Safety Pharmacology Study Design and Data Interpretation

International journal of toxicology, 2020-07, Vol.39 (4), p.274-293

2020

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Anxiolytic and side-effect profile of LY354740: a potent, highly selective, orally active agonist for group II metabotropic glutamate receptors

The Journal of pharmacology and experimental therapeutics, 1998-02, Vol.284 (2), p.651

1998

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Preclinical Abuse Potential Assessment

Handbook of experimental pharmacology, 2015, Vol.229, p.115

Kallman, Mary Jeanne

2015

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Current FDA regulatory guidance on the conduct of drug discrimination studies for NDA review: Does the scientific literature support recent recommendations?

Drug and alcohol dependence, 2016-11, Vol.168, p.307-319

2016

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Nonclinical abuse liability testing of new CNS-active drugs: Role of sex as a critical factor for drug scheduling

Drug science, policy and law, 2021-02, Vol.7

2021

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Drug schedule control status does not limit profit growth: Comparative 4-year analysis

Journal of pharmacological and toxicological methods, 2020-09, Vol.105, p.106837, Article 106837

2020

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Differential temporal response patterns in rat cocaine self-administration studies: The cumulative record dose-response function

Journal of pharmacological and toxicological methods, 2020-09, Vol.105, p.106715, Article 106715

2020

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Differential temporal response patterns for cocaine or hydrocodone in rat self-administration studies

Journal of pharmacological and toxicological methods, 2020-09, Vol.105, p.106716, Article 106716

2020

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Establishing performance characteristics for positive control article selection in drug self-administration studies

Journal of pharmacological and toxicological methods, 2019-05, Vol.97, p.13-23

2019

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Circulating biomarkers of neurotoxicity: Proteomics approach reveals fluidic endpoints of central nervous system toxicity in a rodent model of neurotoxicity

Journal of pharmacological and toxicological methods, 2021-09, Vol.111, p.106983, Article 106983

2021

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Evaluation of intravenous self-administration of ALKS 33 in rats trained to self-administer morphine

Drug and alcohol dependence, 2015-01, Vol.146, p.e96-e96

2015

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Respiratory function in rats restrained for extended periods: Assessment of the effects of bethanecol

Journal of pharmacological and toxicological methods, 2005-07, Vol.52 (1), p.83-89

2005

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Cardiovascular data acquisition and analysis: An SPS industry survey

Journal of pharmacological and toxicological methods, 2020-09, Vol.105, p.106749, Article 106749

2020

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Patency and longevity improvements of self-administration studies based on changes in skin button type and surgical technique in male Sprague–Dawley rats

Journal of pharmacological and toxicological methods, 2015-09, Vol.75, p.160-160

2015

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Serotonin-1A antagonists attenuate the effects of nicotine withdrawal on the auditory startle response

Synapse (New York, N.Y.), 1997-10, Vol.27 (2), p.145-152

1997

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Benchmarking Safety Pharmacology regulatory packages and best practice

Journal of pharmacological and toxicological methods, 2008-09, Vol.58 (2), p.99-109

2008

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Non-clinical safety pharmacology study submission—Data standards and statistical analyses

Journal of pharmacological and toxicological methods, 2009-09, Vol.60 (2), p.210-210

2009

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Comparison of amphetamine and caffeine in preclinical abuse liability and dependence rat studies

Journal of pharmacological and toxicological methods, 2015-09, Vol.75, p.163-163

2015

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Benchmarking Safety Pharmacology Society (SPS) community, practices, and aspirations

Journal of pharmacological and toxicological methods, 2014-11, Vol.70 (3), p.310-310

2014

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Withdrawal Assessment Following Subchronic Oral Ketamine Administration in Cynomolgus macaques

Drug development research, 2014-05, Vol.75 (3), p.162-171

2014

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Correlation and dissociation of measures of chemotherapy-induced peripheral neurotoxicity in male Sprague–Dawley rats intravenously administered Taxol® or Abraxane

Journal of pharmacological and toxicological methods, 2013-07, Vol.68 (1), p.e52-e52

2013

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Advanced Issue Resolution in Safety Pharmacology

Safety pharmacology investigations on the nervous system: An industry survey

EEG in non-clinical drug safety assessments: Current and emerging considerations

CNS Safety Screening Under ICH S7A Guidelines Requires Observations of Multiple Behavioral Units to Assess Motor Function

An Industry Survey With Focus on Cardiovascular Safety Pharmacology Study Design and Data Interpretation

Anxiolytic and side-effect profile of LY354740: a potent, highly selective, orally active agonist for group II metabotropic glutamate receptors

Preclinical Abuse Potential Assessment

Current FDA regulatory guidance on the conduct of drug discrimination studies for NDA review: Does the scientific literature support recent recommendations?

Nonclinical abuse liability testing of new CNS-active drugs: Role of sex as a critical factor for drug scheduling

Drug schedule control status does not limit profit growth: Comparative 4-year analysis

Differential temporal response patterns in rat cocaine self-administration studies: The cumulative record dose-response function

Differential temporal response patterns for cocaine or hydrocodone in rat self-administration studies

Establishing performance characteristics for positive control article selection in drug self-administration studies

Circulating biomarkers of neurotoxicity: Proteomics approach reveals fluidic endpoints of central nervous system toxicity in a rodent model of neurotoxicity

Evaluation of intravenous self-administration of ALKS 33 in rats trained to self-administer morphine

Respiratory function in rats restrained for extended periods: Assessment of the effects of bethanecol

Cardiovascular data acquisition and analysis: An SPS industry survey

Patency and longevity improvements of self-administration studies based on changes in skin button type and surgical technique in male Sprague–Dawley rats

Serotonin-1A antagonists attenuate the effects of nicotine withdrawal on the auditory startle response

Benchmarking Safety Pharmacology regulatory packages and best practice

Non-clinical safety pharmacology study submission—Data standards and statistical analyses

Comparison of amphetamine and caffeine in preclinical abuse liability and dependence rat studies

Benchmarking Safety Pharmacology Society (SPS) community, practices, and aspirations

Withdrawal Assessment Following Subchronic Oral Ketamine Administration in Cynomolgus macaques

Correlation and dissociation of measures of chemotherapy-induced peripheral neurotoxicity in male Sprague–Dawley rats intravenously administered Taxol® or Abraxane

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