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-Reference-Cited by-同舟云学术

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

Published:2022-03-31 Issue:4 Volume:45 Page:333-344
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Roque Pereira Leonardo^ORCID,Durán Carlos E.,Layton Deborah,Poulentzas Georgios,Lalagkas Panagiotis-Nikolaos,Kontogiorgis Christos,Sturkenboom Miriam

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

https://link.springer.com/content/pdf/10.1007/s40264-022-01154-7.pdf

Reference25 articles.

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2. Good E, Practice C. Guidance for Industry Guidance for Industry. Fed Regist. 2004;505:79. https://doi.org/10.1186/1477-7525-4-79.

3. CHMP. EMEA/CHMP/313666/2005-Guideline on the exposure to medicinal products during pregnancy : need for post-authorisation data. Eur Med Agency. 2005.

4. Charlton R, De Vries C. Systematic overview of data sources for drug safety in pregnancy research. Consult EMA/2010/29/CN. 2016;(June 2012). Accessed 07 Sept 2020. http://www.encepp.eu/structure/documents/Data_sources_for_medicines_in_pregnancy_research.pdf.

5. Mueller M, Lewis DJ, Darisi VKK, Horn S. Current challenges in labelling for generic medicinal products: company core data sheet (CCDS) development and maintenance. Pharmaceut Med. 2020. https://doi.org/10.1007/s40290-020-00364-7.

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