دورية أكاديمية
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Supporting Prospective Pregnancy Trials via Modeling and Simulation: Lessons From the Past and Recommendations for the Future.

التفاصيل البيبلوغرافية
العنوان: Supporting Prospective Pregnancy Trials via Modeling and Simulation: Lessons From the Past and Recommendations for the Future.
المؤلفون: Cheung SYA; Certara, Princeton, NJ, USA., Barrett JS; Aridhia Bioinformatics, Glasgow, Scotland, UK.
المصدر: Journal of clinical pharmacology [J Clin Pharmacol] 2023 Jun; Vol. 63 Suppl 1, pp. S51-S61.
نوع المنشور: Journal Article; Review
اللغة: English
بيانات الدورية: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2013- : Oxford : Wiley
Original Publication: Stamford, Conn., Hall Associates.
مواضيع طبية MeSH: Breast Feeding* , Lactation*, Female ; Humans ; Infant, Newborn ; Pregnancy ; Computer Simulation ; Milk, Human ; Prospective Studies
مستخلص: Despite the increasing awareness and guidance to support drug research and development in the pregnant population, there is still a high unmet medical need and off-label use in the pregnant population for mainstream, acute, chronic, rare disease, and vaccination/prophylactic use. There are many obstacles to enrolling the pregnant population in a study, ranging from ethical considerations, the complexity of the pregnancy stages, postpartum, fetus-mother interaction, and drug transfer to breast milk during lactation and impacts on neonates. This review will outline the common challenges of incorporating physiological differences in the pregnant population and historical but noninformative practice in a past clinical trial in pregnant women that led to labeling difficulties. The recommendations of different modeling approaches, such as a population pharmacokinetic model, physiologically based pharmacokinetic modeling, model-based meta-analysis, and quantitative system pharmacology modeling, are presented with some examples. Finally, we outline the gaps in the medical need for the pregnant population by classifying various types of diseases and some considerations that exist to support the use of medicines in this area. Ideas on the potential framework to support clinical trials and collaboration examples are also presented that could also accelerate understanding of drug research and medicine/prophylactics/vaccines in the pregnant population.
(© 2023, The American College of Clinical Pharmacology.)
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فهرسة مساهمة: Keywords: clinical trial; modeling and simulation; pharmacokinetic; pregnancy
تواريخ الأحداث: Date Created: 20230615 Date Completed: 20230619 Latest Revision: 20230619
رمز التحديث: 20231215
DOI: 10.1002/jcph.2284
PMID: 37317497
قاعدة البيانات: MEDLINE
الوصف
تدمد:1552-4604
DOI:10.1002/jcph.2284