Awesome-SEND

Links

• CDISC

SENDIG

• SENDIG_download_pdf
• View SENDIG in html mode

note: HTML version created using Adobe from PDF version

SENDIG online version (html)

DM, BW, LB, MI, OM, TX, TS

Tools

• sendigR - Enable Cross-Study Analysis of CDISC SEND Datasets
• SENDsanitizer
• xptcleaner

reading and writing xpt file in R

• haven
• read and write xpt file with haven
• Hmisc::sasxport.get()
• SASxport::read.xport() and SASxport::write.xport()
• foreign::read.xport()

reading and writing xpt file in python

• pandas.read_sas
• xport
• pyreadstat

reading and writing xpt file in C

• ReadStat_command_Line

• Generating .XPT Files With SAS, R and Python_youtube_

Guidance

• FDA Guidance - Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers

• ICH - guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceutical M3(R2)
• FDA - M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

SEND Related journal articles

• Cross study analyses of SEND data: toxicity profile classification
• sendigR: an R package to leverage the value of CDISC SEND datasets for cross-study analysis
• Making sense of SEND; the Standard for Exchange of Nonclinical Data
• The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promises
• Leveraging the Value of CDISC SEND Data Sets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals

• SEND harmonization & cross-study analysis: A proposal to better harvest the value from SEND data

• Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND)

• Regulatory Forum Commentary*: Through the Looking Glass SENDing the Pathology Data We Have INHAND

• Data Standardization, Pharmaceutical Drug Development, and the 3Rs

• Graphical display of histopathology data from toxicology studies for drug discovery and development: An industry perspective

• The Evolution of SEND at AstraZeneca

journals list

• Toxicological Sciences from SOT
• International Journal of Toxicology (IJT) form ACT
• Regulatory Toxicology and Pharmacology
• Toxicologic Pathology
• Journal of Toxicologic Pathology
• Toxicology and Applied Pharmacology
• Frontiers in Toxicology
• Chemical Research in Toxicology ACS
• Clinical Toxicology
• Critical Reviews in Toxicology
• Trends in Pharmacological Sciences
• Annual Review of Pharmacology and Toxicology
• Reproductive Toxicology
• Neurotoxicity Research
• Cardiovascular Toxicology
• ALTEX

PHUSE Working Groups

• Nonclinical Topics

Books

• A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Blogs

• sensiblesend from Marc Ellison

• SEND Dataset QC: Best Practices & Recommendations
• Understanding CDISC SEND Data and How to Be Compliant
• Non-Clinical (SEND) Reference Guide for Clinical (SDTM) Programmers
• Using NCI controlled terminology for standardizing data

YouTube

• Overview of Non-clinical Assessment in Drug Development
• Most Common Issues with CDISC-SEND Data in FDA Toxicology Review

• Get Ready for CDISC SEND

• Leveraging CDISC SEND Data Sets for Study Analyses
• Certara SEND Webinar Series Session #1
• Data Visualization with SEND Data to See What Happened at the Preclinical Phase
• What’s New for SEND 2023 Webinar
• Best Practices for SEND Dataset Quality Control_https://www.pinnacle21.com/blog

presentation

• Submitting Data to CDER: Requirements for your Application

• FDA Study Data Technical Rejection Criteria (TRC): What you need to know!

Conferences

• American College of Toxicology(ACT)
• Society of Toxicology(SOT)
• phuse
• R in Pharma

INHAND

• Nomenclature: INHAND publications

• International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) progress to date and future plans

• Proliferative and Nonproliferative Lesions of the Rat and Mouse Central and Peripheral Nervous Systems: New and Revised INHAND Terms
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Domain specific journal paper

OM (Organ Measurement)

• Society of Toxicologic Pathology Position Paper: Organ Weight Recommendations for Toxicology Studies
• A note on statistical analysis of organ weights in non-clinical toxicological studies
• Change Trends of Organ Weight Background Data in Sprague Dawley Rats at Different Ages
• The relationship between chemical-induced kidney weight increases and kidney histopathology in rats
• Use of Lung Weight as Biomarker for Assessment of Lung Toxicity in Rat Inhalation Studies