Author: [AUTHOR] Published on 10/5/2023 9:18:00 AM

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CALL FOR PAPERS

Clinical Pharmacology & Therapeutics: Pharmacometrics and Systems Pharmacology (PSP), an official journal of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), is inviting submissions for a special themed issue on Pregnancy scheduled for publication in the 4th quarter of 2024.

The aim of the issue is to illustrate recent applications of pharmacometrics and systems pharmacology to improve and optimize drug therapy for pregnant and lactating women.

Owing to the uncertainty associated with maternal and fetal risk potential following drug exposure, pregnant and lactating women have historically been excluded from or underrepresented in clinical trials. When included, studies have typically been underpowered or key biomarkers omitted; thus, robust maternal and fetal exposure, safety and efficacy assessments including in breastmilk and infants during breastfeeding cannot be conducted. Last year, the FDA published a Draft Guidance on “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry”. Whilst the focus is on race and ethnicity, the FDA encouraged sponsors to also submit plans for other under-represented populations defined by pregnancy and lactation status.

Pharmacometrics and systems pharmacology have been used to guide the drug development process across therapeutic areas and patient populations. This themed issue seeks to spotlight applications of pharmacometrics and systems pharmacology to support and improve clinical trial design, biomarker selection, sample size determination, dose optimization, etc. Submissions are welcome on a range of topics, including, but not limited to

• Study design and simulations supported by modeling
• Model-informed dose optimization
• Systems pharmacology models of fetal, placental, maternal, and lactation states
• Complementary modeling applications using artificial intelligence/machine learning, pharmacoepidemiology, etc.
• Real-world data applications
• Global regulatory perspectives.

This Pregnancy themed issue provides a unique opportunity to exchange knowledge and scientific perspectives across the global quantitative clinical pharmacology community. Specifically, examples of progress to improve clinical development strategies and practices for pregnant and lactating women in low- and middle-income countries using pharmacometrics and systems pharmacology that can be applied to high-income countries are urged. Original research articles are encouraged. Submissions may also include reviews/mini-reviews, tutorials, position/white papers, and perspectives from regulatory agencies, academia, societies, and industry. Please contact alethea@ascpt.org for details about manuscript types and format requirements.

To be considered for publication in this themed issue, manuscripts should be submitted via the online submission and tracking system by May 15, 2024.