Literature DB >> 27060214

Medicine safety in pregnancy and ambitions for the EU medicine regulatory framework.

A Saint-Raymond1, C S de Vries1.   

Abstract

Is the European Union (EU) regulatory framework concerning pregnant women and women at risk of becoming pregnant fit for the purpose? This article discusses improvements in how medicines should be developed and monitored for safe and effective use by pregnant women and women at risk of becoming pregnant.
© 2016 ASCPT.

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Mesh：

Year:  2016        PMID： 27060214     DOI： 10.1002/cpt.378

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  5 in total

1.  Fetal Physiologically-Based Pharmacokinetic Models: Systems Information on Fetal Biometry and Gross Composition.

Authors:  Khaled Abduljalil; Trevor N Johnson; Amin Rostami-Hodjegan
Journal:  Clin Pharmacokinet       Date:  2018-09       Impact factor: 6.447

Review 2.  Challenges in conducting clinical research studies in pregnant women.

Authors:  Monique McKiever; Heather Frey; Maged M Costantine
Journal:  J Pharmacokinet Pharmacodyn       Date:  2020-04-18       Impact factor: 2.745

3.  Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis.

Authors:  Whitney S Krueger; Mary S Anthony; Catherine W Saltus; Andrea V Margulis; Elena Rivero-Ferrer; Brigitta Monz; Ceri Hirst; David Wormser; Elizabeth Andrews
Journal:  Drugs Real World Outcomes       Date:  2017-09

4.  Experiences and Perspectives of Marketing Authorisation Holders towards Medication Safety Monitoring during Pregnancy: A Pan-European Qualitative Analysis.

Authors:  Laure Sillis; Veerle Foulon; Jan Y Verbakel; Michael Ceulemans
Journal:  Int J Environ Res Public Health       Date:  2022-04-02       Impact factor: 3.390

5.  Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach.

Authors:  Rieke van der Graaf; Indira S E van der Zande; Hester M den Ruijter; Martijn A Oudijk; Johannes J M van Delden; Katrien Oude Rengerink; Rolf H H Groenwold
Journal:  Trials       Date:  2018-01-29       Impact factor: 2.279
  5 in total

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