Rubrik: IT
(Treffer aus pharmind, Nr. 05, Seite 460 (2024))
Stueben J | Heitmann M | Baumann I
Good Machine Learning Practices in GxP regulated areas / An overview on regulatory and industry initiatives · Stueben J
1, Heitmann M
2, Baumann I
3 ·
1Boehringer Ingelheim International, Ingelheim,
2d-fine GmbH, Grünwald,
3Thescon GmbH, Coesfeld
Trustworthy AI Regulatory Initiatives Enabling Innovation European Commission FDA Collaborative Approach The first wholly AI-developed drug entered phase 1 trials in 2022 [ 1 ] - though AI is not only about the high-flying breakthroughs regarding new blockbusters or advances in the area of drug design for precision medicine. In fact, there are numerous use cases along the pharma value chain, supporting complex human assessment and decision making as well as control of automatized processes. To name a few examples: Effective knowledge management, mastering the increasingly overwhelming mass of scientific knowledge and literature Novel methodologies to assess clinical data, e.g. ...