Author: [AUTHOR] Published on 12/10/2025 10:27:00 AM
CALL FOR PAPERS
Clinical Pharmacology and Therapeutics (CPT) is seeking submissions for its upcoming special mini-themed issue on "Advances in New Approach Methodologies (NAMs): From Bench Development and Validation to Regulatory Adoption" scheduled for publication in November 2026.
In this issue, we aim to highlight the latest and most innovative advancements in the (i) development of New Approach Methodologies (NAMs) to reduce, refine and replace animal use in drug development; (ii) showcase clinical translation of NAMs for improving pharmacokinetic, pharmacodynamic and toxicity predictions; and (iii) feature regulatory (FDA, EMA, PMDA, etc.) perspective on the evaluation and adoption of NAM-driven data in safety assessments and investigational new drug submissions. Due to the disconnect in translation of preclinical models to the clinic, especially for large molecules, there is an increasing emphasis on the development, qualification/validation, and integration of NAMs as physiologically-relevant approaches to complement or replace traditional preclinical studies across the drug development continuum. This themed issue will explore cutting-edge advancements that are redefining the boundaries of drug safety and efficacy evaluation and enabling the integration of NAMs across drug development and regulatory decision-making frameworks. We welcome submissions on a variety of topics, including but not limited to:
- Microphysiological systems, organ-on-chip technologies and other physiologically-relevant systems for ADME, and toxicity predictions
- Computational NAMs: PBPK and QSP modeling, QSAR, in silico toxicology frameworks, AI/ML-integrated NAMs modeling platforms
- Non-mammalian models (Danio rerio, Drosophila and C. elegans) as alternatives to traditional animal studies
- Integration of multi-omics approaches to enhance mechanistic NAMs-based predictions
- Standardization, qualification and validation of NAMs
- Case studies demonstrating reduced reliability on preclinical studies in regulatory submissions
- Regulatory perspectives, including evaluation pathways, data expectations, and global harmonization for adoption of NAMs
- Role of clinical pharmacologists in advancing, qualifying, and integrating NAMs into drug development
- Limitations and future directions of integrating NAMs in clinical pharmacology and therapeutics
Submissions of original research are particularly encouraged, but reviews, position/white papers, or shorter perspectives are also welcome. Educational, tutorial-style papers will also be considered. In the cover letter of your submission, please state that you are responding to this Call for Papers.
Please contact cpteditor@ascpt.org for details about manuscript types and format requirements, or review our Author Guidelines here.
To be considered for publication in this high-profile themed issue, manuscripts should be submitted via the online submission and tracking system by May 15, 2026
If you would like to make a pre-submission inquiry, please contact the CPT editorial office at cpteditor@ascpt.org.
