{
  "vercy": "1.0-draft",
  "publication": {
    "status": "research-draft",
    "adjudicationStatus": "unreviewed",
    "publishableCanonical": false,
    "generatedAt": "2026-09-12T11:36:13Z",
    "providers": [
      "Codex"
    ],
    "breadth": "recalled by Codex without web access - no source was read",
    "missingProviders": [],
    "pass": 2,
    "cost": {
      "grok": {
        "seconds": 21.6,
        "error": "Reading additional input from stdin...\nOpenAI Codex v0.153.4\n--------\nworkdir: R:\\02_PROJECTS\\02_Meta_Models_Platforms\\Ver.cy\\current\\thing-registry-backlog\nmodel: gpt-6-astra\nprovider: openai\napproval: never\nsandbox: read-only\nreasoning effort: none\nreasoning summaries: none\nsession id: 01a09566-2e79-7be2-bee1-ef861a9cb226\n--------\nuser\nDescribe what is already known about one registered thing. Answer as JSON only, no prose around it.\n\nThing: niraparib\nSense to describe: (none recorded)\nDomain code: PHY.MAT\nAlso known as: (none)\n\n\nContext for this batch of 1001 things:\n# Batch 044: 1001 regis",
        "usd": 0.0,
        "recall": true
      },
      "codex": {
        "seconds": 77.2,
        "error": "Reading additional input from stdin...\nOpenAI Codex v0.153.4\n--------\nworkdir: R:\\02_PROJECTS\\02_Meta_Models_Platforms\\Ver.cy\\current\\thing-registry-backlog\nmodel: gpt-6-astra\nprovider: openai\napproval: never\nsandbox: read-only\nreasoning effort: none\nreasoning summaries: none\nsession id: 01a09566-2e71-70c3-95f6-e95cafde6b6d\n--------\nuser\nYou are drafting a Vercy meta-model for one registered thing. Answer as JSON only, no prose around it.\n\nThing: niraparib\nRegistry id: vr.tr.niraparib\nPlane / domain: PHY / PHY.MAT\nRegistry definition: (none recorded)\nNames folded into this entry: (none)\n\n\nCont"
      }
    },
    "enrichment": {
      "pass": 3,
      "engine": "claude",
      "producedAt": "2026-10-06T12:00:00Z",
      "ingestedAt": "2026-10-06T08:54:23+00:00",
      "fields": [
        "agent_conduct",
        "ethics",
        "failure_modes_and_hazards",
        "owners",
        "visual_identification"
      ]
    },
    "gate": {
      "passed": true,
      "version": "1.0",
      "at": "2026-10-07T10:10:29+00:00",
      "evidence": [
        "completeness 1.00",
        "sense: Wikidata description",
        "2 live sources",
        "review by codex: pass"
      ]
    }
  },
  "metaModel": {
    "id": "THING-Q25326660",
    "registryId": "vr.tr.niraparib",
    "name": "niraparib",
    "version": "0.1.0-research.1",
    "entryKind": "thing",
    "family": "Thing Registry",
    "domain": [
      "PHY.MAT"
    ],
    "status": "research-draft"
  },
  "canonicalUrl": "https://ver.cy/models/thing/q25326660/",
  "model": {
    "registry_id": "vr.tr.niraparib",
    "name": "niraparib",
    "purpose": "Enable an agent to identify niraparib, assess the identity and fitness of a material containing it, and determine which handling or use decisions require additional evidence.",
    "definition": "Niraparib is a small-molecule inhibitor of poly(ADP-ribose) polymerase enzymes PARP1 and PARP2 used as an oral anticancer drug, particularly in maintenance treatment of selected ovarian, fallopian-tube and primary peritoneal cancers.",
    "scope_statement": "This model owns vr.tr.niraparib in PHY / PHY.MAT: the stereochemically defined active substance, its material attributes, and its relationships to salts, analytical evidence, biological activity, and regulated products.",
    "in_scope": [
      "Molecular identity, stereochemistry, and identifiers for niraparib",
      "Explicit relationships between the parent substance, salts, hydrates, and physical forms",
      "Sample composition, purity, analytical identity, and stability",
      "Evidence describing PARP inhibition and its experimental conditions",
      "Substance handling constraints and links to product-specific regulatory evidence"
    ],
    "out_of_scope": [
      "Finished medicine formulations, packaging, and commercial inventory",
      "Patient-specific prescribing, dosing, and treatment monitoring",
      "Cancer classification and individual tumour biomarker interpretation",
      "Manufacturing process design and synthesis execution",
      "Independent models of other PARP inhibitors or combination-product ingredients"
    ],
    "distinguishing_features": [
      "Match molecular connectivity and the S-configured stereocentre, rather than accepting any PARP inhibitor or a matching molecular formula as niraparib. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Niraparib)",
      "For the neutral parent, check C19H20N4O, CAS 1038915-60-4, and PubChem CID 24958200 against structural evidence. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Niraparib)",
      "Distinguish the parent substance from niraparib tosylate monohydrate, which has its own composition and PubChem CID 74763937. [PubChem salt record](https://pubchem.ncbi.nlm.nih.gov/compound/Niraparib-tosylate-monohydrate)",
      "Distinguish a niraparib substance sample from a ZEJULA tablet: a product name does not establish the purity or composition of isolated active material. [FDA label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876s003s004lbl.pdf)"
    ],
    "characteristics": [
      {
        "name": "Chemical identity",
        "kind": "category",
        "unit_or_values": "Verified stereochemical structure; parent-specific CAS and PubChem identifiers",
        "why_it_matters": "Prevents confusion with salts, stereoisomers, and other PARP inhibitors."
      },
      {
        "name": "Material form",
        "kind": "category",
        "unit_or_values": "Neutral parent, specified salt, specified hydrate or solvate; crystalline, amorphous, dissolved, or unresolved",
        "why_it_matters": "Determines which composition, analytical reference, and physical-property evidence apply."
      },
      {
        "name": "Niraparib content",
        "kind": "measurement",
        "unit_or_values": "Mass fraction or mg/mL, with free-base-equivalent versus salt basis and dry versus as-is basis",
        "why_it_matters": "Makes quantities comparable without confusing active-moiety mass with total material mass."
      },
      {
        "name": "Chemical and stereochemical purity",
        "kind": "measurement",
        "unit_or_values": "Assay %, impurity %, and enantiomeric purity or excess %, each with method and reporting basis",
        "why_it_matters": "Separates verified niraparib content from impurities and incorrect stereochemical composition."
      },
      {
        "name": "Water and residual solvent content",
        "kind": "measurement",
        "unit_or_values": "% w/w water; ppm or % w/w identified solvent",
        "why_it_matters": "Supports hydration assessment, quantity correction, and material acceptance."
      },
      {
        "name": "Condition-dependent physical properties",
        "kind": "measurement",
        "unit_or_values": "Solubility in mg/mL with solvent, pH, and temperature; thermal events in °C with method and material form",
        "why_it_matters": "Prevents transferring a salt's solubility or thermal behaviour to the neutral parent."
      },
      {
        "name": "PARP activity evidence",
        "kind": "measurement",
        "unit_or_values": "PARP1 or PARP2 inhibition endpoint in nM or other reported units, linked to assay conditions",
        "why_it_matters": "Allows comparison of biological measurements without treating assay-dependent potency as a universal constant."
      },
      {
        "name": "Sample disposition",
        "kind": "state",
        "unit_or_values": "Unverified, quarantined, accepted for specified use, rejected, or awaiting retest",
        "why_it_matters": "Connects material evidence to a bounded operational decision."
      },
      {
        "name": "Regulatory and product linkage",
        "kind": "relation",
        "unit_or_values": "Named product or substance record, jurisdiction, document version, and effective date",
        "why_it_matters": "Prevents a product authorization from being interpreted as permission for every use of the substance."
      }
    ],
    "affordances": [
      "Resolve a named sample to the niraparib parent identity and its explicitly documented material form.",
      "Calculate niraparib-equivalent quantities when salt stoichiometry, hydration, and assay basis are verified.",
      "Compare a sample's analytical evidence against requirements for a stated research or manufacturing use.",
      "Select suitable storage and handling controls from evidence applicable to the actual material.",
      "Compare PARP activity measurements while preserving assay and biological context.",
      "Route therapeutic-use questions to the applicable medicine and clinical models with dated source links."
    ],
    "agent_conduct": {
      "may": [
        "Explain niraparib as a PARP inhibitor used in maintenance treatment of certain cancers, citing official labelling.",
        "Report approved indications and warnings from the label."
      ],
      "must_not": [
        "Recommend, dose or adjust niraparib for a specific person.",
        "Advise obtaining cancer medicines without a prescription or from unverified sellers.",
        "Present it as a cure or as effective in cancers outside its approved uses without evidence.",
        "Handle cytotoxic medicines without the precautions their label requires."
      ],
      "requires_human": [
        "Starting, stopping or changing cancer treatment for a patient."
      ]
    },
    "ethics": {
      "considerations": [
        "Patients with cancer are vulnerable to false hope and counterfeit drugs.",
        "Genetic testing that guides PARP inhibitor use raises privacy questions."
      ],
      "affected_parties": [
        "Patients with ovarian and related cancers",
        "Families sharing genetic risk",
        "Prescribers and pharmacists"
      ]
    },
    "owners": {
      "steward": "The prescriber and the pharmacist for each patient; medicines regulators authorize products.",
      "master_systems": [
        "National medicines registers"
      ]
    },
    "visual_identification": [
      "Identified by product label, active ingredient name and pack details rather than by appearance alone."
    ],
    "failure_modes_and_hazards": [
      "Low blood counts and bleeding.",
      "Raised blood pressure.",
      "Counterfeit or diverted supply."
    ],
    "what_it_is_for": [
      "Niraparib is encountered as an active pharmaceutical ingredient, an analytical reference material and an ingredient in oral anticancer medicines.",
      "Its clinical role includes maintenance treatment in selected ovarian, fallopian tube and primary peritoneal cancers under jurisdiction-specific authorization.",
      "Material assessment requires distinguishing the chemical form and purity of the ingredient from the composition and quality of a finished medicine."
    ],
    "standards_and_regulation": [
      "The Anatomical Therapeutic Chemical classification, maintained by the WHO Collaborating Centre for Drug Statistics Methodology, classifies niraparib among PARP inhibitors.",
      "The Federal Food, Drug, and Cosmetic Act, enacted by the United States Congress and administered by the Food and Drug Administration, governs niraparib medicines marketed in the United States."
    ]
  },
  "sources": [
    {
      "id": "wikidata",
      "title": "Wikidata item Q25326660: niraparib",
      "url": "https://www.wikidata.org/wiki/Q25326660",
      "url_status": "live",
      "what_it_supports": "identity and sense of the item",
      "checked_by": "wikidata-api"
    },
    {
      "id": "wikipedia-en",
      "title": "Wikipedia: Niraparib",
      "url": "https://en.wikipedia.org/wiki/Niraparib",
      "url_status": "live",
      "what_it_supports": "general description of the item",
      "checked_by": "wikidata-api sitelink"
    }
  ],
  "structure": {
    "bundles": [
      {
        "id": "niraparib-identity",
        "name": "Niraparib identity",
        "description": "Establish the molecular entity represented by the registry entry and distinguish related material identities.",
        "rationale": "Niraparib names and identifiers must resolve to a stereochemically defined entity rather than a loosely named drug material.",
        "layers": [
          {
            "id": "parent-structure",
            "name": "Parent structure",
            "description": "Record connectivity, stereochemistry, and parent-specific identifiers.",
            "findings": [
              {
                "id": "stereochemical-identity",
                "name": "Stereochemical identity",
                "description": "Require a structural match that includes the specified stereocentre; an elemental formula alone is insufficient.",
                "questions": [
                  {
                    "text": "Which stereochemical structure defines niraparib in this registry entry?",
                    "kind": "definition",
                    "id": "stereochemical-identity-q01"
                  },
                  {
                    "text": "Which reference and analytical evidence establish that the sample has the required stereochemistry?",
                    "kind": "provenance",
                    "id": "stereochemical-identity-q02"
                  }
                ]
              }
            ]
          },
          {
            "id": "related-material-identities",
            "name": "Related material identities",
            "description": "Relate salts and hydrates to the niraparib parent without silently equating their compositions.",
            "findings": [
              {
                "id": "salt-hydrate-boundary",
                "name": "Salt and hydrate boundary",
                "description": "Attach counterion, stoichiometry, and hydration evidence to the material description while retaining the parent-substance relationship.",
                "questions": [
                  {
                    "text": "Does the record describe neutral niraparib, niraparib tosylate monohydrate, or another explicitly identified form?",
                    "kind": "boundary",
                    "id": "salt-hydrate-boundary-q01"
                  },
                  {
                    "text": "Which identifiers belong to that form rather than to the niraparib parent?",
                    "kind": "definition",
                    "id": "salt-hydrate-boundary-q02"
                  },
                  {
                    "text": "What evidence establishes the counterion ratio and hydration state?",
                    "kind": "measurement",
                    "id": "salt-hydrate-boundary-q03"
                  }
                ]
              }
            ]
          }
        ]
      },
      {
        "id": "niraparib-composition-quality",
        "name": "Niraparib composition and quality",
        "description": "Describe how much verified niraparib a sample contains and whether its accompanying constituents are acceptable.",
        "rationale": "A niraparib label does not establish active-moiety content, stereochemical purity, or suitability for a specific use.",
        "layers": [
          {
            "id": "content-basis",
            "name": "Content basis",
            "description": "Make niraparib quantity interpretable across parent, salt, hydrated material, and solution.",
            "findings": [
              {
                "id": "active-moiety-accounting",
                "name": "Active-moiety accounting",
                "description": "Record whether reported content refers to niraparib equivalents or total salt material and preserve all correction factors.",
                "questions": [
                  {
                    "text": "Is the reported mass or concentration expressed as niraparib equivalents or as the supplied salt?",
                    "kind": "measurement",
                    "id": "active-moiety-accounting-q01"
                  },
                  {
                    "text": "Which measured assay, water content, and verified stoichiometry support conversion between those bases?",
                    "kind": "measurement",
                    "id": "active-moiety-accounting-q02"
                  }
                ]
              }
            ]
          },
          {
            "id": "impurities-and-acceptance",
            "name": "Impurities and acceptance",
            "description": "Assess chemical, stereochemical, and volatile constituents against a declared use.",
            "findings": [
              {
                "id": "use-specific-quality",
                "name": "Use-specific quality",
                "description": "Keep chemical assay, chromatographic area purity, and enantiomeric purity distinct when judging a niraparib lot.",
                "questions": [
                  {
                    "text": "Which methods quantify niraparib, the undesired enantiomer, related impurities, and residual solvents?",
                    "kind": "measurement",
                    "id": "use-specific-quality-q01"
                  },
                  {
                    "text": "Which specification and reference-standard records justify accepting this lot for the intended use?",
                    "kind": "provenance",
                    "id": "use-specific-quality-q02"
                  },
                  {
                    "text": "Which failed or missing results require quarantine or further analysis?",
                    "kind": "action",
                    "id": "use-specific-quality-q03"
                  }
                ]
              }
            ]
          }
        ]
      },
      {
        "id": "niraparib-physical-state-stability",
        "name": "Niraparib physical state and stability",
        "description": "Connect material form and environmental conditions to measured physical behaviour and retained quality.",
        "rationale": "Physical-property values and storage instructions require evidence for the particular niraparib form and preparation.",
        "layers": [
          {
            "id": "solid-and-solution-behaviour",
            "name": "Solid and solution behaviour",
            "description": "Distinguish solid-state identity from behaviour in a specified solvent environment.",
            "findings": [
              {
                "id": "form-conditioned-properties",
                "name": "Form-conditioned properties",
                "description": "Associate solubility and thermal measurements with the actual salt, hydration state, and experimental conditions.",
                "questions": [
                  {
                    "text": "What evidence identifies the sample's crystalline, amorphous, hydrated, or dissolved state?",
                    "kind": "measurement",
                    "id": "form-conditioned-properties-q01"
                  },
                  {
                    "text": "Under which pH, solvent, temperature, and equilibration conditions was niraparib solubility measured?",
                    "kind": "measurement",
                    "id": "form-conditioned-properties-q02"
                  },
                  {
                    "text": "Does a reported thermal event represent melting, dehydration, another transition, or decomposition?",
                    "kind": "boundary",
                    "id": "form-conditioned-properties-q03"
                  }
                ]
              }
            ]
          },
          {
            "id": "storage-and-retest",
            "name": "Storage and retest",
            "description": "Evaluate whether storage and preparation history preserve the specified material quality.",
            "findings": [
              {
                "id": "stability-supported-disposition",
                "name": "Stability-supported disposition",
                "description": "Base storage, solution holding time, and retest decisions on evidence applicable to the material and container.",
                "questions": [
                  {
                    "text": "Which stability data support the storage conditions and retest interval for this niraparib form?",
                    "kind": "provenance",
                    "id": "stability-supported-disposition-q01"
                  },
                  {
                    "text": "Have temperature, humidity, light exposure, or solution-storage conditions exceeded the supported range?",
                    "kind": "measurement",
                    "id": "stability-supported-disposition-q02"
                  },
                  {
                    "text": "Which excursion or degradation result requires retesting or rejection?",
                    "kind": "action",
                    "id": "stability-supported-disposition-q03"
                  }
                ]
              }
            ]
          }
        ]
      },
      {
        "id": "niraparib-biological-activity",
        "name": "Niraparib biological activity",
        "description": "Organize evidence about niraparib's interaction with PARP and its context-dependent cellular effects.",
        "rationale": "Niraparib is a PARP inhibitor, but measurements of target inhibition and biological response require distinct experimental contexts. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Niraparib)",
        "layers": [
          {
            "id": "parp-target-assays",
            "name": "PARP target assays",
            "description": "Separate target-specific measurements and mechanistic endpoints.",
            "findings": [
              {
                "id": "assay-specific-potency",
                "name": "Assay-specific potency",
                "description": "Preserve the target, endpoint, and assay conditions behind each reported niraparib activity value.",
                "questions": [
                  {
                    "text": "Does the experiment measure PARP1 inhibition, PARP2 inhibition, PARP-DNA trapping, or another endpoint?",
                    "kind": "definition",
                    "id": "assay-specific-potency-q01"
                  },
                  {
                    "text": "What concentration-response value, uncertainty, and assay conditions were reported?",
                    "kind": "measurement",
                    "id": "assay-specific-potency-q02"
                  },
                  {
                    "text": "Was the niraparib preparation's identity, purity, and dissolved concentration verified?",
                    "kind": "provenance",
                    "id": "assay-specific-potency-q03"
                  }
                ]
              }
            ]
          },
          {
            "id": "cellular-response-context",
            "name": "Cellular response context",
            "description": "Keep cell-level response evidence attached to its biological system and exposure conditions.",
            "findings": [
              {
                "id": "response-transfer-limits",
                "name": "Response transfer limits",
                "description": "Record the conditions needed to interpret a niraparib response without converting laboratory activity into clinical eligibility.",
                "questions": [
                  {
                    "text": "Which cell system, DNA-repair characteristics, exposure duration, and response endpoint define the observation?",
                    "kind": "measurement",
                    "id": "response-transfer-limits-q01"
                  },
                  {
                    "text": "What evidence supports transferring this result to another experimental system?",
                    "kind": "provenance",
                    "id": "response-transfer-limits-q02"
                  },
                  {
                    "text": "Where must interpretation pass to a tumour, biomarker, or clinical-treatment model?",
                    "kind": "boundary",
                    "id": "response-transfer-limits-q03"
                  }
                ]
              }
            ]
          }
        ]
      },
      {
        "id": "niraparib-handling-use-boundaries",
        "name": "Niraparib handling and use boundaries",
        "description": "Connect material-specific handling evidence and dated medicine records to permissible actions.",
        "rationale": "Chemical handling controls and authorized therapeutic uses depend on different evidence and cannot be inferred from the substance name alone.",
        "layers": [
          {
            "id": "occupational-material-controls",
            "name": "Occupational material controls",
            "description": "Assess handling of niraparib powder, solutions, and waste using evidence matched to the supplied material.",
            "findings": [
              {
                "id": "handling-evidence",
                "name": "Handling evidence",
                "description": "Record applicable safety classification and exposure controls without inventing a universal GHS category or exposure limit.",
                "questions": [
                  {
                    "text": "Which current safety data sheet covers the exact niraparib form, concentration, and supplier?",
                    "kind": "provenance",
                    "id": "handling-evidence-q01"
                  },
                  {
                    "text": "Is there an authoritative exposure limit or documented occupational control band for this material?",
                    "kind": "provenance",
                    "id": "handling-evidence-q02"
                  },
                  {
                    "text": "Which containment, spill-response, and waste procedures apply to the planned powder or solution operation?",
                    "kind": "action",
                    "id": "handling-evidence-q03"
                  }
                ]
              }
            ]
          },
          {
            "id": "medicine-regulatory-links",
            "name": "Medicine regulatory links",
            "description": "Link the active substance to products while preserving jurisdiction, formulation, and label version.",
            "findings": [
              {
                "id": "product-specific-authority",
                "name": "Product-specific authority",
                "description": "Represent approved uses through dated product records rather than as unrestricted permissions attached to niraparib.",
                "questions": [
                  {
                    "text": "Which product, formulation, jurisdiction, and effective label version support the proposed therapeutic-use claim?",
                    "kind": "provenance",
                    "id": "product-specific-authority-q01"
                  },
                  {
                    "text": "Does the evidence concern niraparib as a single active ingredient or within a combination product?",
                    "kind": "boundary",
                    "id": "product-specific-authority-q02"
                  },
                  {
                    "text": "Which eligibility, dosing, and monitoring decisions must be resolved in the linked medicine and patient-care models?",
                    "kind": "action",
                    "id": "product-specific-authority-q03"
                  }
                ]
              }
            ]
          }
        ]
      },
      {
        "id": "evidence-and-external-alignment",
        "name": "Evidence and external alignment",
        "description": "What the world already says about this thing, gathered so the model can be checked against it.",
        "rationale": "A model that cannot be lined up against existing standards, identifiers and practice cannot be adopted by anyone who already uses them.",
        "layers": [
          {
            "id": "reported-evidence",
            "name": "Reported evidence",
            "description": "Findings from the breadth pass, kept separate from the structural claims.",
            "findings": [
              {
                "id": "evidence-confidence-notes",
                "name": "Check these first",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  "This is recalled knowledge; no sources were consulted.",
                  "Verify current jurisdiction-specific indications and biomarker restrictions before describing clinical eligibility.",
                  "Confirm form-specific registry identifiers, purity specifications, physical constants and occupational hazard classification; free-base and salt-hydrate data are not interchangeable."
                ],
                "questions": [
                  {
                    "id": "evidence-confidence-notes-q01",
                    "text": "Which of these check these first hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              },
              {
                "id": "evidence-kinds",
                "name": "Kinds and varieties",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  "Niraparib free base",
                  "Niraparib tosylate monohydrate"
                ],
                "questions": [
                  {
                    "id": "evidence-kinds-q01",
                    "text": "Which of these kinds and varieties hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              },
              {
                "id": "evidence-identifiers",
                "name": "Identifiers and schemes",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  {
                    "scheme": "International Nonproprietary Name (INN)",
                    "value_or_pattern": "niraparib",
                    "note": "Nonproprietary name for the active drug substance."
                  },
                  {
                    "scheme": "CAS Registry Number",
                    "value_or_pattern": "1038915-60-4",
                    "note": "Identifies niraparib free base; salt and hydrate forms require separate identifiers."
                  },
                  {
                    "scheme": "Molecular formula",
                    "value_or_pattern": "C19H20N4O",
                    "note": "Formula of the free base, excluding counterion and water of crystallization."
                  },
                  {
                    "scheme": "Development code",
                    "value_or_pattern": "MK-4827",
                    "note": "Historical drug-development identifier."
                  }
                ],
                "questions": [
                  {
                    "id": "evidence-identifiers-q01",
                    "text": "Which of these identifiers and schemes hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              },
              {
                "id": "evidence-standards-and-regulation",
                "name": "Standards and regulation",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  "US Food and Drug Administration prescribing information governs approved indications, dosing and safety labeling for niraparib medicinal products.",
                  "European Commission marketing authorization and European Medicines Agency product information govern authorized use in the European Union."
                ],
                "questions": [
                  {
                    "id": "evidence-standards-and-regulation-q01",
                    "text": "Which of these standards and regulation hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              },
              {
                "id": "evidence-real-world-use",
                "name": "Real-world use",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  "Maintenance therapy in selected patients with ovarian, fallopian-tube or primary peritoneal cancer following response to platinum-based chemotherapy."
                ],
                "questions": [
                  {
                    "id": "evidence-real-world-use-q01",
                    "text": "Which of these real-world use hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              },
              {
                "id": "evidence-measurements",
                "name": "Typical measurements",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  {
                    "quantity": "Molar mass of niraparib free base",
                    "typical_range": "320.39",
                    "unit": "g/mol"
                  }
                ],
                "questions": [
                  {
                    "id": "evidence-measurements-q01",
                    "text": "Which of these typical measurements hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              },
              {
                "id": "evidence-failure-modes-and-hazards",
                "name": "Failure modes and hazards",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  "Bone-marrow suppression, including thrombocytopenia, anemia and neutropenia.",
                  "Hypertension and other cardiovascular effects requiring monitoring during treatment.",
                  "Rare but serious myelodysplastic syndrome or acute myeloid leukemia.",
                  "Embryo-fetal toxicity.",
                  "Acquired tumor resistance can reduce treatment effectiveness."
                ],
                "questions": [
                  {
                    "id": "evidence-failure-modes-and-hazards-q01",
                    "text": "Which of these failure modes and hazards hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              },
              {
                "id": "evidence-regional-variation",
                "name": "Regional variation",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  "Approved indications, biomarker requirements and treatment-line restrictions differ by jurisdiction and have changed over time."
                ],
                "questions": [
                  {
                    "id": "evidence-regional-variation-q01",
                    "text": "Which of these regional variation hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              },
              {
                "id": "evidence-neighbours",
                "name": "Neighbouring kinds and how to tell them apart",
                "description": "Recalled without web access and unsourced; every item is a lead to verify.",
                "evidence": [
                  {
                    "name": "Niraparib tosylate monohydrate",
                    "difference": "A salt hydrate containing niraparib, a tosylate counterion and water of crystallization; its composition and molar mass differ from those of the free base."
                  },
                  {
                    "name": "Zejula",
                    "difference": "A branded medicinal product containing niraparib; the product includes a dosage form and excipients and is not identical to the isolated substance."
                  },
                  {
                    "name": "Olaparib",
                    "difference": "A different molecular entity in the PARP-inhibitor drug class, with its own pharmacology, formulations and approved indications."
                  }
                ],
                "questions": [
                  {
                    "id": "evidence-neighbours-q01",
                    "text": "Which of these neighbouring kinds and how to tell them apart hold for the sense of niraparib this model covers, and on what evidence?",
                    "kind": "provenance"
                  }
                ]
              }
            ]
          }
        ]
      }
    ]
  },
  "openQuestions": [
    "Does the existing Vercy catalogue already contain a canonical niraparib model, and how does it represent the parent substance versus salt and hydrate forms?",
    "Which authoritative specifications establish impurity limits, stereochemical acceptance criteria, and validated analytical methods for each intended material grade?",
    "Which measured solubility, thermal, solid-state, and stability data apply specifically to the neutral parent and to each supplied salt or hydrate?",
    "Which current material-specific safety classifications, EC identifiers where applicable, and occupational exposure limits or control bands can be substantiated?",
    "Which primary assay studies and current jurisdiction-specific product records are needed to support biological activity and therapeutic-use links?"
  ],
  "statistics": {
    "bundles": 6,
    "layers": 11,
    "findings": 19,
    "questions": 37
  }
}
