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International Journal of Toxicology|April 18, 2022
Exploring the Definition of "Similar Toxicities": Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two SpeciesHelen Prior, David O Clarke, David Jones, et al.
International Journal of Toxicology|June 1, 2024
Exploring Greater Flexibility for Chronic Toxicity Study Designs to Support Human Safety Assessment While Balancing 3Rs ConsiderationsHelen Prior, Paul Baldrick, David O Clarke, et al.
Toxicologic Pathology|March 24, 2016
The Use of Minipigs for Preclinical Safety Assessment by the Pharmaceutical Industry: Results of an IQ DruSafe Minipig SurveyCurtis Colleton, David Brewster, Anne Chester, et al.
Drug Delivery and Translational Research|August 25, 2016
An assessment of the central disposition of intranasally administered insulin lispro in the cerebrospinal fluid of healthy volunteers and beagle dogsStephen Lowe, Emanuele Sher, Graham Wishart, et al.
Clinical Pharmacology and Therapeutics|August 7, 2020
Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) AssessmentMichael W Leach, David O Clarke, Sherri Dudal, et al.
Psychopharmacology|February 12, 2013
A review of the abuse potential assessment of atomoxetine: a nonstimulant medication for attention-deficit/hyperactivity disorderHimanshu P Upadhyaya, Durisala Desaiah, Kory J Schuh, et al.
Regulatory Toxicology and Pharmacology : RTP|October 31, 2024
Opportunities and challenges for use of minipigs in nonclinical pharmaceutical development: Results of a follow-up IQ DruSafe surveyDavid O Clarke, Kaushik Datta, Kevin French, et al.
Regulatory Toxicology and Pharmacology : RTP|January 17, 2023
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remainHelen Prior, Laura Andrews, Annick Cauvin, et al.
Regulatory Toxicology and Pharmacology : RTP|January 2, 2023
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approachHsiao-Tzu Chien, Helen Prior, Laura Andrews, et al.
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