Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products

Tassinari Melissa S.; Sahin Leyla; Yao Lynne P.

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Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products

机译：评估用于妊娠的药物引起的先天性畸形风险：NBDPS在处方药产品的妊娠标签中的作用

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BackgroundObtaining human pregnancy data to inform product labeling is important for drug and biological products.

机译：背景技术获取人类妊娠数据以告知产品标签对于药物和生物产品很重要。

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《Birth defects research, Part A. Clinical and molecular teratology》 |2015年第8期|共3页
作者
Tassinari Melissa S.; Sahin Leyla; Yao Lynne P.;
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正文语种 eng
中图分类生物形态学;
关键词
NBDPS; FDA; pregnancy labeling;

机译：NBDPS;FDA;怀孕标签;

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1. Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products [J] . Tassinari Melissa S., Sahin Leyla, Yao Lynne P. Birth defects research, Part A. Clinical and molecular teratology . 2015,第8期

机译：评估用于妊娠的药物引起的先天性畸形风险：NBDPS在处方药产品的妊娠标签中的作用
2. Antihypertensive medication use during pregnancy and the risk of major congenital malformations or small-for-gestational-age newborns [J] . Nakhai-PourH.R., ReyE., BérardA. Birth defects research, Part B. Developmental and reproductive toxicology . 2010,第2期

机译：怀孕期间使用降压药以及发生重大先天性畸形或小胎龄新生儿的风险
3. Challenges in assessing the use of antibiotics during pregnancy and risk of congenital malformations [J] . Cao Brent Liu, Xu Colin British Journal of Clinical Pharmacology . 2020,第3期

机译：在怀孕期间评估使用抗生素的挑战和先天性畸形的风险
4. The Malformation Risks for the Children Resulted from Therapeutically Induced Pregnancies [C] . C. Musuroi, A. Motoc, M. Motoc, European Congress of Perinatal Medicine . 2008

机译：儿童的畸形风险是由治疗诱导的怀孕引起的
5. Safety Signal Detection for Antihypertensive Drug-Induced Cleft Lip and/or Palate and Evaluation of Risk Perception for Medication Use in Pregnancy Among Mothers With Children With Cleft Lip and/or Palate. [D] . Palaska, Pinelopi-Kleio. 2013

机译：降压药物诱发的唇裂和/或Pal裂的安全性信号检测，以及对有唇裂和/或Pal裂患儿的母亲进行妊娠用药的风险感知评估。
6. Challenges in assessing the use of antibiotics during pregnancy and risk of congenital malformations [O] . Brent Liu Cao, Colin Xu 2020

机译：在怀孕期间评估使用抗生素的挑战和先天性畸形的风险
7. Consumption of medicines in high-risk pregnancy: evaluation of determinants related to the use of prescription drugs and self-medication [O] . Danielle Dayse Araújo, Marineide Marinho Leal, Eliane Jucielly Vasconcelos Santos, 2013

机译：高风险妊娠中药物的消费：评估与处方药的使用和自我药物相关的决定因素
8. Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products. Content and Format. Guidance for Industry (Small Entity Compliance Guide). [R] . 2015

机译：怀孕，哺乳和生殖潜力：人类处方药和生物制品的标签。内容和格式。行业指南（小实体合规指南）。

Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products

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