Yousuf28/Awesome-SEND

links related to SEND/Nonclinical toxicology

Awesome-SEND

Links

• CDISC

Tools

• sendigR - Enable Cross-Study Analysis of CDISC SEND Datasets
• SENDsanitizer
• xptcleaner
• haven
• read xpt file

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 paper

• 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

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

presentations

• 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