A Comprehensive Approach to Selection of Adverse Drug Reactions for a Drug with Conditional Marketing Authorisation in the European Union
A combination of statistical parameters and medical judgement should be considered for the selection of undesirable effects for the product label and for the safety risk classification.
Authors
- Nataša Lazarević
- Alexandra Martin (ORCID: https://orcid.org/0000-0001-9764-9487)
- Emiel van Heumen (ORCID: https://orcid.org/0009-0008-6391-8691)
- Britta Jeanette Schorn
- Axel Leporowski
- Norbert Hittel
- Vivian Zhang
- Vinu George
Institutions
- Otsuka (United States) (US)
- Novel (Germany) (DE)
- Otsuka (Germany) (DE)
Publication Details
- Journal
- Advances in Therapy
- Published
- 2026-02-12
- DOI
- https://doi.org/10.1007/s12325-026-03504-8
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00