Qualitative analysis of actual Standard for Exchange of Nonclinical Data (SEND) datasets for Data Domains: Proposition from Japan Pharmaceutical Manufacturers Association SEND Taskforce Team on standardization of nonclinical data.
Regul Toxicol Pharmacol
; 122: 104919, 2021 Jun.
Article
in En
| MEDLINE
| ID: mdl-33753112
ABSTRACT
The Standard for Exchange of Nonclinical Data (SEND) has been adopted by the US FDA, which has required pharmaceutical companies who are developing new drugs for the US market to implement SEND. The Japan Pharmaceutical Manufacturers Association (JPMA) SEND Taskforce Team responded to this situation by starting a project to better understand the contents of SEND datasets. The project focused on domains generally included in the SEND domains for single- and repeat-dose general toxicology studies, and surveyed what kind of information are populated in which domains and in what way. The qualitative analysis of the results indicated that variations exist based on whether or not an individual variable was populated and on how the variable was populated. The Taskforce Team recommends reducing variations not only in the SEND datasets but also in the descriptions in the study protocol and/or final study report. Reduction of such variations should lead to higher quality datasets with powerful and increased searchability so that accumulated SEND datasets should become more valuable. These efforts would provide regulatory agencies with easier review of SEND datasets, which contributes to efficient development of new drug candidates.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Databases as Topic
/
Biomedical Research
/
Drug Industry
Type of study:
Qualitative_research
/
Risk_factors_studies
Limits:
Humans
Country/Region as subject:
America do norte
/
Asia
Language:
En
Journal:
Regul Toxicol Pharmacol
Year:
2021
Document type:
Article