@article{1901,
  keywords = {context of use},
  author = {Szczepan W. Baran and Paul C. Brown and Andreas R. Baudy and Suzanne C. Fitzpatrick and Christopher Frantz and Aaron Fullerton and Jinping Gan and Rhiannon N. Hardwick and Kathleen M. Hillgren and Anna K. Kopec and Jennifer L. Liras and Donna L. Mendrick and Ryan Nagao and William R. Proctor and Diane Ramsden and Alexandre J. S. Ribeiro and David Stresser and Kyung E. Sung and Radhakrishna Sura and Kazuhiro Tetsuka and Lindsay Tomlinson and Terry Van Vleet and Matthew P. Wagoner and Qin Wang and Sevim Yildiz Arslan and Gorm Yoder and Jason E. Ekert},
  title = {Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate)},
  abstract = {Complex in vitro models (CIVM) offer the potential to improve pharmaceutical clinical drug attrition due to safety and/ or efficacy concerns. For this technology to have an impact, the establishment of robust characterization and qualifi­cation plans constructed around specific contexts of use (COU) is required. This article covers the output from a workshop between the Food and Drug Administration (FDA) and Innovation and Quality Microphysiological Systems (IQ MPS) Affiliate. The intent of the workshop was to understand how CIVM technologies are currently being applied by pharma­ceutical companies during drug development and are being tested at the FDA through various case studies in order to identify hurdles (real or perceived) to the adoption of microphysiological systems (MPS) technologies, and to address evaluation/qualification pathways for these technologies. Output from the workshop includes the alignment on a working definition of MPS, a detailed description of the eleven CIVM case studies presented at the workshop, in-depth analysis, and key take aways from breakout sessions on ADME (absorption, distribution, metabolism, and excretion), pharmacology, and safety that covered topics such as qualification and performance criteria, species differences and concordance, and how industry can overcome barriers to regulatory submission of CIVM data. In conclusion, IQ MPS Affiliate and FDA scientists were able to build a general consensus on the need for animal CIVMs for preclinical species to better determine species concordance. Furthermore, there was acceptance that CIVM technologies for use in ADME, pharmacology and safety assessment will require qualification, which will vary depending on the specific COU.},
  year = {2022},
  journal = {Alternatives to Animal Experimentation},
  volume = {39},
  pages = {297-314},
  month = {2022-04-11},
  issn = {1868-8551},
  url = {https://www.altex.org/index.php/altex/article/view/2406},
  doi = {10.14573/altex.2112203},
  language = {en},
}