Best Practices

One Health Initiative

• STP Support of One Health Initiative

Data Interpretation⁄Management

• Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions
• Points to Consider on the Statistical Analysis of Rodent Cancer Bioassay Data When Incorporating Historical Control Data
• Examples of Historical Data Presentation
• Stand Alone HCD Reference List
• Evaluation of Organ Weights for Rodent and Non-rodent Toxicity Studies: A Review of Regulatory Guidelines and a Survey of Current Practices
• Pathology Image Data: Compliance with 21 CFR Parts 58 and 11
• Pathology Position on Histopathology Data Collection and Audit Trail
• Assessment of Hyperplastic Lesions in Rodent Carcinogenicity Studies
• Recommendations on Classification of Rodent Neoplasms for Peto Analysis

Study Design

• Organ Weight Recommendations for Toxicology Studies
• Best Practices Guideline: Toxicologic Histopathology
• Recommended Tissue List for Histopathologic Examination in Repeat-Dose Toxicity and Carcinogenicity Studies
• Diet as a Variable in Rodent Toxicology and Carcinogenicity Studies

Study Reports⁄Peer Review

• Pathology Peer Review Recommendations—2010
• Best Practices for Reporting Pathology Interpretations within GLP Toxicology Studies
• Documentation of Pathology Peer Review
• Peer Review in Toxicologic Pathology: Some Recommendations

System⁄Organ Specific

• Best Practice Guideline for Routine Pathology Evaluation of the Immune System
• Ovarian Follicular Counting in the Assessment of Rodent Reproductive Toxicity
• Guidelines for the Evaluation of Testicular Toxicity
• STP Position Paper: A ‘Best Practices’ Approach to Neuropathologic Assessment
  in Developmental Neurotoxicity Testing—for Today
• (ASVCP) Selection and Interpretation of Clinical Pathology Indicators of
  Hepatic Injury in Preclinical Studies

Draft position papers can be reviewed by STP members on the STP Members' site.