FDAsafety guidance72% confidence
Cancer Clinical Trial Eligibility Criteria: Laboratory Values
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Sichuan Baili Pharmaceutical Co., Ltd..
Regulatory Analysis
The purposes of eligibility criteria for cancer clinical trials are to select the intended patient population and reduce potential risks to trial subjects.
Supporting Context
- Therapeutic area
- Oncology · NSCLC
- Sub-indication
- Lung Cancer
Related signal: Phase II/III Trial of BL-B01D1 with Osimertinib in EGFR-mutant NSCLC Initiated