PMID- 37598916
OWN - NLM
STAT- MEDLINE
DCOM- 20231002
LR  - 20231003
IS  - 1878-5832 (Electronic)
IS  - 1359-6446 (Linking)
VI  - 28
IP  - 10
DP  - 2023 Oct
TI  - Building a nonclinical pathology laboratory of the future for pharmaceutical 
      research excellence.
PG  - 103747
LID - S1359-6446(23)00263-5 [pii]
LID - 10.1016/j.drudis.2023.103747 [doi]
AB  - We describe a roadmap for a fully digital artificial intelligence (AI)-augmented 
      nonclinical pathology laboratory across three continents. Underpinning the design 
      are Good Laboratory Practice (GLP)-validated laboratory information management 
      systems (LIMS), whole slide-scanners (WSS), image management systems (IMS), and a 
      digital microscope intended for use by the nonclinical pathologist. Digital 
      diagnostics are supported by tools that include AI-based virtual staining and 
      deep learning-based decision support. Implemented during the COVID-19 pandemic, 
      the initial digitized workflow largely mitigated disruption of pivotal 
      nonclinical studies required to support pharmaceutical clinical testing. We 
      believe that this digital transformation of our nonclinical pathology 
      laboratories will promote efficiency and innovation in the future and enhance the 
      quality and speed of drug development decision making.
CI  - Copyright (c) 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.
FAU - Rudmann, D G
AU  - Rudmann DG
AD  - Charles River Laboratories, Digital Toxicologic Pathology, Discovery and Safety 
      Assessment, Wilmington, DE, USA. Electronic address: daniel.rudmann@crl.com.
FAU - Bertrand, L
AU  - Bertrand L
AD  - Charles River Laboratories, Digital Toxicologic Pathology, Discovery and Safety 
      Assessment, Wilmington, DE, USA.
FAU - Zuraw, A
AU  - Zuraw A
AD  - Charles River Laboratories, Digital Toxicologic Pathology, Discovery and Safety 
      Assessment, Wilmington, DE, USA.
FAU - Deiters, J
AU  - Deiters J
AD  - Charles River Laboratories, Digital Toxicologic Pathology, Discovery and Safety 
      Assessment, Wilmington, DE, USA.
FAU - Staup, M
AU  - Staup M
AD  - Charles River Laboratories, Digital Toxicologic Pathology, Discovery and Safety 
      Assessment, Wilmington, DE, USA.
FAU - Rivenson, Y
AU  - Rivenson Y
AD  - Pictor, Inc., Los Angeles, CA, USA.
FAU - Kuklyte, J
AU  - Kuklyte J
AD  - Deciphex Ltd., Dublin, Ireland.
LA  - eng
PT  - Journal Article
DEP - 20230819
PL  - England
TA  - Drug Discov Today
JT  - Drug discovery today
JID - 9604391
SB  - IM
MH  - Humans
MH  - Artificial Intelligence
MH  - Laboratories
MH  - Pandemics
MH  - *Pharmaceutical Research
MH  - *COVID-19
OTO - NOTNLM
OT  - Artificial intelligence
OT  - Decision support
OT  - Deep learning
OT  - Digital microscopy
OT  - Drug development
OT  - Good Laboratory Practice
OT  - Nonclinical
OT  - Pathology
OT  - Toxicology
OT  - Virtual staining
EDAT- 2023/08/21 00:41
MHDA- 2023/10/02 06:41
CRDT- 2023/08/20 19:27
PHST- 2023/07/12 00:00 [received]
PHST- 2023/08/02 00:00 [revised]
PHST- 2023/08/14 00:00 [accepted]
PHST- 2023/10/02 06:41 [medline]
PHST- 2023/08/21 00:41 [pubmed]
PHST- 2023/08/20 19:27 [entrez]
AID - S1359-6446(23)00263-5 [pii]
AID - 10.1016/j.drudis.2023.103747 [doi]
PST - ppublish
SO  - Drug Discov Today. 2023 Oct;28(10):103747. doi: 10.1016/j.drudis.2023.103747. 
      Epub 2023 Aug 19.