Author: [AUTHOR] Published on 5/25/2023 12:00:00 AM

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CALL FOR PAPERS

The journal Clinical Pharmacology and Therapeutics (CPT) is seeking submissions for its upcoming special themed issue on "Subcutaneous Biologics: Clinical Pharmacology and Drug Development” that is scheduled for publication in early 2024.

In this issue, we aim to showcase the current landscape, most innovative efforts, perspectives, and future directions in the development of subcutaneous (SC) biologic therapies as it pertains to quantitative clinical pharmacology and therapeutics. Subcutaneous delivery of biologics has become a preferred route of administration. It is proven to be effective, safe, and well-tolerated in many different diseases and across a variety of biologic constructs. The SC route of administration provides a more convenient and patient-friendly option than intravenously (IV) administered medicines. In addition, it has the potential to reduce the burden on the healthcare system by enabling home-based dosing. With such benefits, drug development strategies and delivery devices to support SC administration of biologics are rapidly and continuously evolving. The bridging from IV to SC delivery of biologics carries tremendous opportunities for the discipline of quantitative clinical pharmacology as it positively influences the development of SC formulations and overcomes the SC drug development paradigm. This themed issue calls for scientific input and knowledge dissemination on the SC administration of biologics from the broader quantitative clinical pharmacology community. We welcome submissions on a variety of topics within the theme of clinical pharmacology and pharmacometrics of the SC delivery for biologics, including but not limited to:

• Bridging strategies for IV/SC routes of administration for biologics
• MIDD strategies for SC dose selection and clinical study design 
• Immunogenicity of SC route and its impact on exposure, efficacy, and safety
• Clinical trials and MIDD strategies for SC delivery devices (device development, switch of device, injection volume limitation, etc.)   
• Regulatory perspectives to support the development of SC administration for biologics
• Other routes of administration (for instance, intramuscular) will be considered.

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 September 29, 2023.

If you would like to make a pre-submission inquiry, please contact the CPT editorial office at cpteditor@ascpt.org.