Mining scientific advice reports on cell-based products: Insight into the nonclinical development program.

Tineke van den HoornTahira NakchediA Charlotte M T de WolfAnna M G PasmooijJan Willem van der LaanCarla A Herberts

Published in: British journal of clinical pharmacology (2020)

Compared to more conventional medicinal products, the nonclinical development program for cell-based products was more tailored and focused on proof-of-concept. For tumourigenicity an in vitro approach may suffice. Total omission of in vivo studies appears to be possible for products with sufficient clinical experience.

Keyphrases

single cell
cell therapy
quality improvement
emergency department
mesenchymal stem cells
smoking cessation