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PTN, PHARMACEUTICALS (PK) AND SAFETY OF COMMONLY USED DRUGS IN LACTATING WOMEN AND BREASTFED INFANTS (CUDDLE 2.0) NETWORK

PTN, PHARMACEUTICALS (PK) AND SAFETY OF COMMONLY USED DRUGS IN LACTATING WOMEN AND BREASTFED INFANTS (CUDDLE 2.0) NETWORK
PTN、药品 (PK) 以及哺乳期妇女和母乳喂养婴儿常用药物的安全性 (CUDDLE 2.0) 网络
批准号:
10495378
负责人:
KANECIA ZIMMERMAN
金额:
$41.62万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-09-23 至 2024-09-22

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中文摘要
翻译
ClinicalTrials.gov标识:NCT03511118 这项突破性的研究由PTN进行,旨在评估常用的非专利药物在给哺乳母亲时的安全性。 对于新妈妈来说,出现必须用药物治疗的症状或身体状况是很常见的。由于担心药物会伤害她们的孩子,这些母亲经常为是否服药而苦苦挣扎。通过这项研究,PTN的目标是找到对母亲和她们的母乳喂养的婴儿都安全的常用药物剂量。 儿科试验网络(PTN)正在进行一项开创性的研究,以评估常用的非专利药物在给哺乳母亲时的安全性。这项研究将跟踪不同的药物如何通过母乳传递,以确定对母亲和婴儿都安全的剂量水平。尽管美国食品和药物管理局
英文摘要
ClinicalTrials.gov Identifier: NCT03511118 This groundbreaking study, conducted by the PTN, is designed to assess the safety of commonly used off-patent medications when they are given to breastfeeding mothers. It is common for new mothers to have symptoms or medical conditions that must be treated with drugs. These mothers often struggle with their decision to take their medications because of the fear that the drugs will harm their children. With this study, PTN aims to find doses of commonly used drugs that are safe for both mothers and their breastfed infants. The Pediatric Trials Network (PTN) is undertaking a groundbreaking study to assess the safety of commonly used off-patent medications when they are given to breastfeeding mothers. The study will track how different drugs are passed through breastmilk to determine dosing levels that are safe for both mom and baby. Although the U.S. Food and Drug Administration
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BPCA PHARMACOEPIDEMIOLOGY (REAL WORLD DATA) STUDIES
  • 批准号:
    10475400
  • 项目类别:
  • 资助金额:
    $60.0万
  • 财政年份:
    2021
  • 负责人:
    KANECIA ZIMMERMAN
  • 依托单位:
BPCA INNOVATIVE TRIAL DESIGNS FOR DOSING, SAFETY, AND EFFICACY IN PEDIATRIC THERAPEUTICS
  • 批准号:
    10267019
  • 项目类别:
  • 资助金额:
    $34.92万
  • 财政年份:
    2019
  • 负责人:
    KANECIA ZIMMERMAN
  • 依托单位:
BPCA INNOVATIVE TRIAL DESIGNS FOR DOSING, SAFETY, AND EFFICACY IN PEDIATRIC THERAPEUTICS
  • 批准号:
    10019016
  • 项目类别:
  • 资助金额:
    $1.57万
  • 财政年份:
    2019
  • 负责人:
    KANECIA ZIMMERMAN
  • 依托单位:
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