Document detail
ID
oai:pubmedcentral.nih.gov:1074...
Topic
Review ArticleAuthor
Bartel, Detlef Bonertz, Andreas Hartenstein, Diana Kaul, Stefan Lauer, Iris Reeb, Christina Rösner-Friese, Karen Sliva, Katja Zimmer, Julia Vieths, Stefan Mahler, VeraLangue
enEditor
Dustri-Verlag Dr. Karl Feistle
Category
Allergologie Select
Year
2023
listing date
2/9/2024
Keywords
aitAbstract
Allergen immunotherapy (AIT) has been performed for 112 years.
In this article we summarize regulatory standards and challenges based on scientific evidence on AIT.
Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level.
The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main in Germany, examines and evaluates the benefits and risks of AIT products within the course of clinical development, marketing authorization, and subsequently throughout their entire life cycle to ensure high-quality, safe, and effective AIT products.
Bartel, Detlef,Bonertz, Andreas,Hartenstein, Diana,Kaul, Stefan,Lauer, Iris,Reeb, Christina,Rösner-Friese, Karen,Sliva, Katja,Zimmer, Julia,Vieths, Stefan,Mahler, Vera, 2023, Allergen-specific immunotherapy and evidence: A European regulatory perspective , Dustri-Verlag Dr. Karl Feistle
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