FDAsafety guidance83% confidence
Cancer Clinical Trial Eligibility Criteria: Laboratory Values
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AstraZeneca.
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 · ADC
- Sub-indication
- General
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