EMA perspective on the value of model‐informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding-Reference-Cited by-同舟云学术

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EMA perspective on the value of model‐informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding

Published:2024-08-13 Issue: Volume: Page:
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacom & Syst Pharma

Author:

Manolis Efthymios¹,Musuamba Flora Tshinanu²³,de Vries Corinne S.¹^ORCID,Colin Pieter J.¹⁴^ORCID,Oleksiewicz Martin B.⁵

Affiliation:

1. European Medicines Agency Amsterdam The Netherlands

2. Federal Agency for Medicines and Health Products Brussel Belgium

3. University of Namur Namur Belgium

4. University Medical Center Groningen University of Groningen Groningen The Netherlands

5. Danish Medicines Agency Copenhagen Denmark

Publisher

Wiley

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.13214

Reference17 articles.

1. A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project

2. Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION

3. Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

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

5. Assuring access to safe medicines in pregnancy and breastfeeding;Nooney J;Clin Pharm Ther,2021

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