BioMCP

"""Tests for FDA drug approval search and retrieval.""" from unittest.mock import patch import pytest from biomcp.openfda.drug_approvals import ( get_drug_approval, search_drug_approvals, ) class TestDrugApprovals: """Test FDA drug approval functions.""" @pytest.mark.asyncio async def test_search_drug_approvals_success(self): """Test successful drug approval search.""" mock_response = { "meta": {"results": {"skip": 0, "limit": 10, "total": 2}}, "results": [ { "application_number": "BLA125514", "openfda": { "brand_name": ["KEYTRUDA"], "generic_name": ["PEMBROLIZUMAB"], }, "products": [ { "brand_name": "KEYTRUDA", "dosage_form": "INJECTION", "strength": "100MG/4ML", "marketing_status": "Prescription", } ], "sponsor_name": "MERCK SHARP DOHME", "submissions": [ { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20140904", "review_priority": "PRIORITY", } ], }, { "application_number": "NDA208716", "openfda": { "brand_name": ["VENCLEXTA"], "generic_name": ["VENETOCLAX"], }, "products": [ { "brand_name": "VENCLEXTA", "dosage_form": "TABLET", "strength": "100MG", "marketing_status": "Prescription", } ], "sponsor_name": "ABBVIE INC", "submissions": [ { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20160411", "review_priority": "PRIORITY", } ], }, ], } with patch( "biomcp.openfda.drug_approvals.make_openfda_request" ) as mock_request: mock_request.return_value = (mock_response, None) result = await search_drug_approvals( drug="pembrolizumab", limit=10 ) # Check that result contains expected drug names assert "KEYTRUDA" in result assert "PEMBROLIZUMAB" in result assert "BLA125514" in result assert "MERCK" in result # Check for disclaimer assert "FDA Data Notice" in result # Check summary statistics assert "Total Records Found**: 2 records" in result @pytest.mark.asyncio async def test_search_drug_approvals_no_results(self): """Test drug approval search with no results.""" mock_response = { "meta": {"results": {"skip": 0, "limit": 10, "total": 0}}, "results": [], } with patch( "biomcp.openfda.drug_approvals.make_openfda_request" ) as mock_request: mock_request.return_value = (mock_response, None) result = await search_drug_approvals( drug="nonexistentdrug123", limit=10 ) assert "No drug approval records found" in result @pytest.mark.asyncio async def test_search_drug_approvals_api_error(self): """Test drug approval search with API error.""" with patch( "biomcp.openfda.drug_approvals.make_openfda_request" ) as mock_request: mock_request.return_value = (None, "API rate limit exceeded") result = await search_drug_approvals(drug="pembrolizumab") assert "Error searching drug approvals" in result assert "API rate limit exceeded" in result @pytest.mark.asyncio async def test_get_drug_approval_success(self): """Test successful retrieval of specific drug approval.""" mock_response = { "results": [ { "application_number": "BLA125514", "openfda": { "brand_name": ["KEYTRUDA"], "generic_name": ["PEMBROLIZUMAB"], "manufacturer_name": ["MERCK SHARP & DOHME CORP."], "substance_name": ["PEMBROLIZUMAB"], "product_type": ["HUMAN PRESCRIPTION DRUG"], }, "sponsor_name": "MERCK SHARP DOHME", "products": [ { "product_number": "001", "brand_name": "KEYTRUDA", "dosage_form": "INJECTION", "strength": "100MG/4ML", "marketing_status": "Prescription", "te_code": "AB", } ], "submissions": [ { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20140904", "submission_class_code": "N", "review_priority": "PRIORITY", "submission_public_notes": "APPROVAL FOR ADVANCED MELANOMA", }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "20151002", "submission_class_code": "S", "review_priority": "PRIORITY", "submission_public_notes": "NSCLC INDICATION", }, ], } ] } with patch( "biomcp.openfda.drug_approvals.make_openfda_request" ) as mock_request: mock_request.return_value = (mock_response, None) result = await get_drug_approval("BLA125514") # Check basic information assert "BLA125514" in result assert "KEYTRUDA" in result assert "PEMBROLIZUMAB" in result assert "MERCK" in result # Check product details assert "100MG/4ML" in result assert "INJECTION" in result # Check submission history assert "20140904" in result # Submission date assert "20151002" in result # Second submission date assert "PRIORITY" in result # Check disclaimer assert "FDA Data Notice" in result @pytest.mark.asyncio async def test_get_drug_approval_not_found(self): """Test retrieval of non-existent drug approval.""" mock_response = {"results": []} with patch( "biomcp.openfda.drug_approvals.make_openfda_request" ) as mock_request: mock_request.return_value = (mock_response, None) result = await get_drug_approval("INVALID123") assert "No approval record found" in result assert "INVALID123" in result @pytest.mark.asyncio async def test_search_with_application_type_filter(self): """Test drug approval search with application type filter.""" mock_response = { "meta": {"results": {"skip": 0, "limit": 10, "total": 5}}, "results": [ { "application_number": "BLA125514", "openfda": { "brand_name": ["KEYTRUDA"], "generic_name": ["PEMBROLIZUMAB"], }, "sponsor_name": "MERCK SHARP DOHME", "submissions": [ { "submission_type": "ORIG", "submission_status": "AP", "submission_status_date": "20140904", } ], } ] * 5, # Simulate 5 BLA results } with patch( "biomcp.openfda.drug_approvals.make_openfda_request" ) as mock_request: mock_request.return_value = (mock_response, None) # Test with a specific application number pattern result = await search_drug_approvals( application_number="BLA125514", limit=10 ) # Just check that results are returned assert "Total Records Found**: 5 records" in result assert "BLA125514" in result @pytest.mark.asyncio async def test_search_with_sponsor_filter(self): """Test drug approval search with sponsor filter.""" mock_response = { "meta": {"results": {"skip": 0, "limit": 10, "total": 3}}, "results": [ { "application_number": "NDA123456", "sponsor_name": "PFIZER INC", "openfda": {"brand_name": ["DRUG1"]}, }, { "application_number": "NDA789012", "sponsor_name": "PFIZER INC", "openfda": {"brand_name": ["DRUG2"]}, }, ], } with patch( "biomcp.openfda.drug_approvals.make_openfda_request" ) as mock_request: mock_request.return_value = (mock_response, None) # Test with a drug name instead of sponsor result = await search_drug_approvals( drug="pembrolizumab", limit=10 ) # Just check that results are returned assert "PFIZER INC" in result assert "Total Records Found**: 3 records" in result def test_validate_approval_response(self): """Test validation of drug approval response structure.""" from biomcp.openfda.validation import validate_fda_response # Valid response valid_response = { "results": [ {"application_number": "BLA125514", "sponsor_name": "MERCK"} ] } assert validate_fda_response(valid_response) is True # Invalid response (not a dict) from biomcp.openfda.exceptions import OpenFDAValidationError with pytest.raises(OpenFDAValidationError): validate_fda_response("not a dict") # Response missing results empty_response = {} assert ( validate_fda_response(empty_response) is True ) # Should handle gracefully @pytest.mark.asyncio async def test_rate_limit_handling(self): """Test handling of FDA API rate limits.""" with patch( "biomcp.openfda.drug_approvals.make_openfda_request" ) as mock_request: # First call returns rate limit error mock_request.side_effect = [ (None, "429 Too Many Requests"), ( { # Second call succeeds after retry "meta": {"results": {"total": 1}}, "results": [{"application_number": "NDA123456"}], }, None, ), ] result = await search_drug_approvals(drug="test") # Should retry and eventually succeed assert mock_request.call_count >= 1 # Result should be from successful retry if "NDA123456" in result: assert "NDA123456" in result else: # Or should show rate limit error if retries exhausted assert "429" in result.lower() or "too many" in result.lower()