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Validating content accuracy and generating insightsPrinceps Lifesciences - PCP 785
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Final Princeps Lifesciences CSR
Word • 2.3 MB • Version 1.0 • Last edited 2h ago
An Open-Label, Randomized, Single-Dose, Parallel Group Study in Healthy Subjects to Assess the Bioequivalence of PCP 7855 Following Subcutaneous Administration...
PCP 785
Postmenopausal osteoporosis
Princeps Lifesciences Inc., Thousand Oaks, CA
QC Results
Not Ready11 issues found across 8 categories
Issues by Category
Issue Details
Data Integrity & Accuracy Error
Inconsistent Numerical Values
Category: Data Integrity & Accuracy Errors
Numbers, statistics, or endpoints do not match source data, CRF, TFLs, or protocol. This discrepancy may lead to regulatory compliance issues.
Highlighted Issue in Document
...mg/mL Concentration Versus 70 mg/mL Concentration
Investigational Product: PCP 785
Indication: Postmenopausal osteoporosis
Brief Description: An open-label, randomized, parallel-group study designed to assess the pharmacokinetic (PK) bioequivalence, safety, tolerability, and immunogenicity of a single 210 -mL dose of PCP 785 when administered in either a 70-mg/mL or 120-mg/mL concentration to healthy subjects...
Source Context
Expected dose: 210 mg administered as 1.5 mL of PCP 785
Expected Format
How it should appear
Correct concentration value format:
"210 mg/1.5 mL""140 mg/mL concentration"What's Wrong
Root cause analysis
Missing numerical value before unit
The text shows "-mL" which is invalid. This likely resulted from:
- Data extraction error during document conversion
- Table cell merge or formatting issue
- Missing value in source template
Regulatory References
Compliance guidelines
- PK concentration values must include numeric value + unit
- Standard formats: 120 mg/mL, 500 ng/mL
- FDA Bioanalytical Method Validation Guidance specifies reporting requirements
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