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08:59
An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
Methods in safety pharmacology in focus.
Michael K Pugsley1, David J Gallacher, Rob Towart
1Johnson & Johnson PR&D, Global Preclinical Toxicology/Pathology, Raritan, NJ 00869, USA. MPugsle2@its.jnj.com
Journal of Pharmacological and Toxicological Methods
|August 19, 2008
Summary
This issue presents diverse safety pharmacology methods beyond cardiovascular studies, including neurobehavioral assessments and biological agent testing. It highlights evolving industry practices and the translation of non-clinical findings to human safety.
Area of Science:
- Pharmacology
- Toxicology
- Drug Development
Background:
- This focused issue features articles from the 7th Annual Safety Pharmacology Society (SPS) meeting.
- Content expands beyond traditional cardiovascular safety to include non-cardiovascular methods and reviews.
Discussion:
- Includes neurobehavioral assessments in non-human primates and drug effects in juvenile/adult rats, relevant to pediatric legislation.
- Features methodological papers on cardiovascular drug sensitivity in non-human primates and fractal analysis of canine heartbeat dynamics.
- Presents a working group's recommendations on safety pharmacology testing for biological therapeutic agents, including monoclonal antibodies (mAbs).
Key Insights:
- A new focus on non-cardiovascular safety pharmacology methods, including central nervous system (CNS) and biological agents.
- Industry practices are examined through an SPS survey on ICH S7A/S7B trends, early safety studies, and contract research organization (CRO) assays.
- The translation of non-clinical safety findings to human applications is discussed, alongside the use of zebrafish as an early screening assay.
Outlook:
- Recommendations for biological safety testing are expected to shape regulatory strategies.
- The evolving landscape of safety pharmacology emphasizes a broader range of methods and applications.
- Continued focus on translating non-clinical data for improved human safety assessment.
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