# Microgram: ich-e1-population-exposure

`station__algovigilance__microgram-ich-e1-population-exposure` · native (always callable) · domain `algovigilance` · pv-relevance `pv-core`

ICH E1 Population Exposure to Assess Clinical Safety. Routes minimum safety database size for drugs intended for long-term treatment of non-life-threatening conditions. Covers standard requirements (300-600 at 6 months, 100 at 12 months, ~1500 total) and 5 exception categories requiring larger or allowing smaller databases. Source: ICH E1 Step 4, 27 October 1994.

## Agent metadata

- `idempotent`: true
- `read_only`: true
- `expected_latency_ms`: unknown (not yet contract-tested)
- `cost_tokens_estimate`: unknown

## Input schema

- `treatment_duration` *string* (required) — long_term (>6 months chronic or repeated intermittent) or short_term
- `condition_severity` *string* (required) — non_life_threatening or life_threatening
- `has_exception` *boolean* — Whether an exception condition applies
- `exception_type` *string* — late_developing_ade, low_frequency_ade, small_benefit, background_morbidity, small_population
- `region` *string* — us, eu, japan (default: general/all regions)
- `is_priority_drug` *boolean* — US priority drug designation

## Example call

```json
POST /api/mcp
Content-Type: application/json

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__algovigilance__microgram-ich-e1-population-exposure",
    "arguments": {
      "treatment_duration": "",
      "condition_severity": ""
    }
  }
}
```

## Related

- [/tools](/tools) — all 7718 tools
- [/tools/algovigilance__microgram-ich-e1-population-exposure](/tools/algovigilance__microgram-ich-e1-population-exposure) — HTML page
- [/tools/algovigilance__microgram-ich-e1-population-exposure/json](/tools/algovigilance__microgram-ich-e1-population-exposure/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide