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The pre‐ and post‐authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation

机译：欧洲药品管理局发布的关于妊娠和哺乳期间使用生物制剂的授权前后数据

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摘要

The effects of biologics on reproduction/lactation are mostly unknown although many patients that receive biologics are women of reproductive age. The first objective of this study was to investigate the publicly available data on pregnancy/lactation before and after marketing authorization in Europe of biologics for the indications of rheumatologic inflammatory autoimmune diseases and inflammatory bowel disease. Secondary objectives included the assessment of the clinical relevance of the provided data and comparison of initial and post‐authorization data.

机译：尽管许多接受生物制剂治疗的患者均为育龄妇女，但对生物制剂对生殖/哺乳的影响尚不清楚。这项研究的第一个目的是调查在风湿性炎症性自身免疫性疾病和炎症性肠病适应症的生物制剂在欧洲上市之前和之后有关妊娠/哺乳的公开数据。次要目标包括评估所提供数据的临床相关性以及比较初始数据和授权后数据。

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期刊名称 British Journal of Clinical Pharmacology
作者
N. Ghalandari; R.J.E.M. Dolhain; J.M.W. Hazes; C.L.E. Siezen; J.W. van der Laan; H.J.M.J. Crijns; E.P. van Puijenbroek; C.J. van der Woude;
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作者单位

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年(卷),期 2020(86),3
年度 2020
页码 -1
总页数 11
原文格式 PDF
正文语种
中图分类药学;
关键词
biologics; gastroenterology; lactation; pregnancy; rheumatology;

机译：生物制剂;消化内科;泌乳;妊娠;风湿病;

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专利

1. The pre‐ and post‐authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation [J] . N. Ghalandari, R.J.E.M. Dolhain, J.M.W. Hazes, British journal of clinical pharmacology . 2020,第3期

机译：欧洲药物在怀孕和哺乳期间使用生物制剂的使用前和授权后的数据
2. The pre‐ and post‐authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation [J] . Ghalandari N., Dolhain R.J.E.M., Hazes J.M.W., British Journal of Clinical Pharmacology . 2020,第3期

机译：欧洲药物在怀孕和哺乳期间使用生物制剂的使用前和授权后的数据
3. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. [J] . Permanand G, Mossialos E, McKee M Clinical medicine: journal of the Royal College of Physicians of London . 2006,第1期

机译：欧洲药品监管：欧洲药品管理局，市场授权，透明度和药物警戒。
4. The Medicines Control Agency's product licence database [C] . Lazell, B., Davies, . 1994

机译：药品管制局的产品许可证数据库
5. DHA functional foods in pregnancy and lactation: Effects on maternal and infant DHA status and immediate postnatal neurobehavioral function and breast milk DHA [D] . de Mare, Charlotte Ingrid Marianne 2006

机译：妊娠和哺乳期DHA功能食品：对母婴DHA状态以及出生后即刻神经行为功能和母乳DHA的影响
6. Regulating medicines in Europe: the European Medicines Agency marketing authorisation transparency and pharmacovigilance [O] . Govin Permanand, Elias Mossialos, Martin McKee 2006

机译：在欧洲规范药品：欧洲药品管理局市场授权透明度和药物警戒
7. Charlton RA, Neville AJ, Jordan S, Pierini A, Damse-Michel C, Klungsøyr K, Nybo Anderson AM, Hansen AV, Gini R, Bos J, Puccini A, Hurault-Delarue C, Brooks CJ, de Jong van den Berg LTW, de Vries CS Healthcare databases in Europe for studying medicine use and safety during pregnancy Journal Pharmacoepidemiology and Drug Safety , 2014, Published Ahead-of-Print. DOI: 10.1002/pds.3613 [O] . Jordan, Sue 2014

机译：Charlton Ra，Neville aJ，Jordan s，pierini a，Damse-michel C，KlungsøyrK，Nybo anderson am，Hansen aV，Gini R，Bos J，puccini a，Hurault-Delarue C，Brooks CJ，de Jong van den Berg LTW ，de Vries Cs欧洲医疗保健数据库，用于研究妊娠期间的药物使用和安全性，期刊药物流行病学和药物安全，2014年，出版前期。 DOI：10.1002 / pds.3613
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）。

The pre‐ and post‐authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation

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