Aileen Milne
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View article: Rodent home cage monitoring for preclinical safety pharmacology assessment: results of a multi-company validation evaluating nonclinical and clinical data from three compounds
Rodent home cage monitoring for preclinical safety pharmacology assessment: results of a multi-company validation evaluating nonclinical and clinical data from three compounds Open
Introduction The presence of central nervous system (CNS) safety concerns during early clinical testing that were not picked up in standard preclinical assessment is a major cause of attrition in drug development. It is also very expensive…
View article: Neurofunctional test batteries in safety pharmacology – Current and emerging considerations for the drug development process
Neurofunctional test batteries in safety pharmacology – Current and emerging considerations for the drug development process Open
Regulatory guidelines recommend specialised safety pharmacology assessments in animals to characterise drug-induced effects on the central nervous system (CNS) prior to first-in-human trials, including the functional observational battery …
View article: Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies
Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies Open
Although the majority of the industry does not yet socially house animals during telemetry recordings in safety pharmacology and toxicology studies, there is support to implement this refinement. Continued discussions, sharing of best prac…