{"schema":"https://ver.cy/schemas/card/1.0.0","id":"vr.tr.doravirine","code":"thing-q6885419","url":"https://ver.cy/models/thing/q6885419/","name":"doravirine","alternateNames":[],"kind":"thing","status":"published","version":"0.1.0-research.1","language":"en","classifiers":{"family":"Thing Registry","category":"Physical world and living systems","entryKind":"thing","plane":"PHY","domain":["PHY.MAT"],"industry":[],"navPath":"","tags":[],"facets":{}},"whatItIs":"Doravirine is a synthetic small-molecule non-nucleoside reverse transcriptase inhibitor (NNRTI) used with other antiretroviral agents to treat HIV-1 infection.","purpose":"Enable an agent to recognise doravirine, assess the identity and fitness of its material lots, and identify evidence governing handling and pharmaceutical use.","scope":{"in":["Molecular identity, identifiers and analytical confirmation of doravirine","Material grade, assay, impurities and lot provenance","Solid form, solubility, stability and condition-dependent physical measurements","HIV-1 reverse transcriptase inhibition and resistance evidence","Substance handling hazards and links to pharmaceutical authorisations"],"out":["Finished tablet formulations, packaging and product release","Patient diagnosis, prescribing and individual treatment decisions","Complete antiretroviral regimens and their clinical management","Manufacturing routes, equipment and process execution","Separate identities of metabolites, impurities and companion active ingredients"],"boundaries":[]},"distinguishingFeatures":["Match the molecular structure as well as CAS 1338225-97-0 and PubChem CID 58460047; molecular formula alone cannot establish identity. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Doravirine)","Use C17H11ClF3N5O3 as a composition consistency check and recognise MK-1439 as a development synonym. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Doravirine)","Distinguish its HIV-1 non-nucleoside reverse transcriptase inhibitor role from other antiretroviral mechanisms. [PIFELTRO label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76ce1f00-28c0-4314-bd2c-d473fe3d0970)","Distinguish doravirine substance from PIFELTRO tablets: a product containing doravirine has formulation and authorisation attributes beyond the molecule. [PIFELTRO label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76ce1f00-28c0-4314-bd2c-d473fe3d0970)"],"structure":{"bundles":[{"id":"doravirine-identity","name":"Doravirine identity","description":"Establish which chemical entity and material specimen a doravirine record denotes.","layers":[{"id":"molecular-recognition","name":"Molecular recognition","description":"Resolve the name to a molecular structure and confirm the specimen against it.","findings":[{"id":"structure-and-identity-evidence","name":"Structure and identity evidence","description":"Require agreement between the registered entity, structure identifiers and orthogonal analytical evidence.","questions":[{"text":"Which authoritative structure record defines the doravirine entity represented by vr.tr.doravirine?","id":"structure-and-identity-evidence-q01","kind":"definition"},{"text":"Which reference-standard comparisons and spectroscopic or chromatographic results establish the specimen's identity?","id":"structure-and-identity-evidence-q02","kind":"measurement"}]}]},{"id":"substance-product-boundary","name":"Substance and product boundary","description":"Separate doravirine material from medicines and mixtures containing it.","findings":[{"id":"ingredient-versus-formulation","name":"Ingredient versus formulation","description":"Represent medicine names as linked product records rather than interchangeable identities for a material lot.","questions":[{"text":"Does this record denote doravirine API, an analytical solution or a formulated medicine?","id":"ingredient-versus-formulation-q01","kind":"boundary"},{"text":"Which product or mixture record owns the excipients, companion active ingredients and declared strength?","id":"ingredient-versus-formulation-q02","kind":"boundary"}]}]}]},{"id":"doravirine-material-fitness","name":"Doravirine material fitness","description":"Assess whether a particular lot has the composition and physical state needed for its intended use.","layers":[{"id":"assay-and-impurity-control","name":"Assay and impurity control","description":"Connect composition measurements to specifications and lot provenance.","findings":[{"id":"lot-composition-acceptability","name":"Lot composition acceptability","description":"Evaluate doravirine content, related substances, water and residual solvents using the applicable specification.","questions":[{"text":"What assay basis, impurity results and analytical methods are documented for this doravirine lot?","id":"lot-composition-acceptability-q01","kind":"measurement"},{"text":"Which certificate, specification revision and supplier qualification support accepting this lot for its declared use?","id":"lot-composition-acceptability-q02","kind":"provenance"}]}]},{"id":"solid-form-and-solution-behaviour","name":"Solid form and solution behaviour","description":"Preserve the conditions under which physical properties were measured.","findings":[{"id":"condition-qualified-material-properties","name":"Condition-qualified material properties","description":"Record experimentally assigned solid form and measured solubility or thermal behaviour without inventing universal constants.","questions":[{"text":"What diffraction or thermal evidence identifies the solid state of this doravirine sample?","id":"condition-qualified-material-properties-q01","kind":"measurement"},{"text":"Under which solvent, pH, temperature and equilibration conditions were its solubility and stability measured?","id":"condition-qualified-material-properties-q02","kind":"measurement"}]}]}]},{"id":"doravirine-biological-activity","name":"Doravirine biological activity","description":"Represent antiviral activity and exposure dependencies with their experimental and clinical boundaries.","layers":[{"id":"target-and-resistance","name":"Target and resistance","description":"Relate reverse transcriptase inhibition to variant-specific susceptibility measurements.","findings":[{"id":"assay-bounded-antiviral-effect","name":"Assay-bounded antiviral effect","description":"Keep biochemical inhibition, cell-based antiviral activity and clinical resistance interpretation distinct.","questions":[{"text":"Does the reported doravirine result measure isolated enzyme inhibition, viral replication or clinical response?","id":"assay-bounded-antiviral-effect-q01","kind":"definition"},{"text":"Which HIV-1 genotype, reference virus and assay conditions support the reported potency or resistance fold change?","id":"assay-bounded-antiviral-effect-q02","kind":"measurement"}]}]},{"id":"exposure-and-interactions","name":"Exposure and interactions","description":"Attach pharmacokinetic observations and interaction evidence to their study context.","findings":[{"id":"contextual-exposure-evidence","name":"Contextual exposure evidence","description":"Treat exposure as dependent on administered product, dose, population and co-medication rather than as a fixed substance constant.","questions":[{"text":"Which formulation, dosing conditions and population produced each reported doravirine exposure measurement?","id":"contextual-exposure-evidence-q01","kind":"provenance"},{"text":"Which current label or interaction study should a connected regimen model consult when a CYP3A-modifying medicine is present?","id":"contextual-exposure-evidence-q02","kind":"action"}]}]}]},{"id":"doravirine-handling-and-use-status","name":"Doravirine handling and use status","description":"Determine what material handling and downstream use are supported by current evidence.","layers":[{"id":"storage-and-occupational-handling","name":"Storage and occupational handling","description":"Connect bulk doravirine handling to material-specific safety and stability documentation.","findings":[{"id":"supported-handling-conditions","name":"Supported handling conditions","description":"Use the applicable SDS and lot documentation to assess containment, storage excursions and retest status.","questions":[{"text":"Which doravirine SDS establishes the applicable hazard classification and any occupational exposure guidance?","id":"supported-handling-conditions-q01","kind":"provenance"},{"text":"Do this lot's storage history and stability evidence support continued use, retesting or quarantine?","id":"supported-handling-conditions-q02","kind":"action"}]}]},{"id":"regulatory-and-clinical-evidence-links","name":"Regulatory and clinical evidence links","description":"Connect the substance to dated, jurisdiction-specific product permissions and safety evidence.","findings":[{"id":"bounded-use-authority","name":"Bounded use authority","description":"Require an explicit product and jurisdiction before applying authorised indications or clinical safety requirements to a proposed use.","questions":[{"text":"Which authorised medicinal product, jurisdiction and label revision govern the contemplated doravirine use?","id":"bounded-use-authority-q01","kind":"provenance"},{"text":"Which restrictions or safety updates must be passed to the product or clinical model before it evaluates that use?","id":"bounded-use-authority-q02","kind":"action"}]}]}]},{"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.","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.","questions":[{"text":"Which of these check these first hold for the sense of doravirine this model covers, and on what evidence?","id":"evidence-confidence-notes-q01","kind":"provenance"}]},{"id":"evidence-identifiers","name":"Identifiers and schemes","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these identifiers and schemes hold for the sense of doravirine this model covers, and on what evidence?","id":"evidence-identifiers-q01","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.","questions":[{"text":"Which of these standards and regulation hold for the sense of doravirine this model covers, and on what evidence?","id":"evidence-standards-and-regulation-q01","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.","questions":[{"text":"Which of these real-world use hold for the sense of doravirine this model covers, and on what evidence?","id":"evidence-real-world-use-q01","kind":"provenance"}]},{"id":"evidence-measurements","name":"Typical measurements","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these typical measurements hold for the sense of doravirine this model covers, and on what evidence?","id":"evidence-measurements-q01","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.","questions":[{"text":"Which of these failure modes and hazards hold for the sense of doravirine this model covers, and on what evidence?","id":"evidence-failure-modes-and-hazards-q01","kind":"provenance"}]},{"id":"evidence-regional-variation","name":"Regional variation","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these regional variation hold for the sense of doravirine this model covers, and on what evidence?","id":"evidence-regional-variation-q01","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.","questions":[{"text":"Which of these neighbouring kinds and how to tell them apart hold for the sense of doravirine this model covers, and on what evidence?","id":"evidence-neighbours-q01","kind":"provenance"}]}]}]}]},"agentConduct":{"may":["Identify doravirine by name, identifiers and documented properties, citing sources.","Report approved uses and interactions from official product information.","Check a material lot's certificate of analysis against its specification."],"mustNot":["Recommend a regimen change or dose for a particular person living with HIV.","Disclose or infer a person's HIV status from medication data.","Supply it outside lawful pharmaceutical channels.","Suggest it can be taken alone or that it cures HIV."],"requiresHuman":["Any decision to start, stop or switch antiretroviral treatment.","Releasing or destroying a material lot."]},"ethics":{"considerations":["HIV status carries stigma; any data about treatment is highly sensitive.","Uninterrupted access to antiretrovirals is a matter of life and global equity."],"affectedParties":["People living with HIV","Partners and families","Prescribers and pharmacists"]},"owners":{"steward":"The marketing authorization holder for each medicine; the national medicines regulator oversees it.","roles":[],"masterSystems":["National medicines registers"]},"relations":[{"target":"Q11173","type":"parent","note":"registry parent class"}],"interaction":{"identity":{"applicability":"required","items":["Vercy registry: vr.tr.doravirine","Wikidata: Q6885419 (https://www.wikidata.org/wiki/Q6885419)"]},"properties":{"applicability":"required","items":["Chemical identity: Structure-resolved doravirine; CAS 1338225-97-0; PubChem CID 58460047","Doravirine assay: % mass fraction, with as-is or corrected basis and analytical method","Material grade: Reference standard, research material or pharmaceutical API; documented specification","Related substances and residuals: Individual and total impurities in % or ppm; water and residual solvents with methods","Physical and solid state: Phase, crystalline or amorphous character, assigned solid form, temperature and humidity","Solubility: mg/mL or mol/L; solvent, pH, temperature, solid form and equilibration method","Thermal behaviour: °C with method, pressure and identification of melting, transition or decomposition","Antiviral susceptibility: EC50 or IC50 in nM; fold change against a named reference, genotype and assay","Metabolic interaction dependency: CYP3A interaction evidence linked to a dated medicinal product label","Handling classification: Jurisdiction-specific GHS classification, SDS revision and exposure limit if established; otherwise unresolved"]},"recognition":{"applicability":"required","items":["Identity rests on the label, batch record and certificate of analysis, not appearance.","Available alone and in fixed-dose combinations, so labels must be read in full."]},"capabilities":{"applicability":"required","items":["Reconcile a doravirine supplier record with molecular identifiers and analytical identity evidence.","Assess a material lot against the specification for its declared grade and intended use.","Select documented conditions for sampling, solution preparation and storage.","Compare antiviral measurements only after aligning assay conditions and viral variants.","Flag relevant interaction evidence for a connected medicinal product or regimen model.","Trace an acceptance, rejection or unresolved assessment to its supporting certificate, study or regulatory document."]},"hazards":{"applicability":"required","items":["Interactions with drugs that induce liver enzymes can make treatment fail.","Missed doses or monotherapy can lead to resistance.","Falsified antiretrovirals endanger patients and public health."]},"interfaces":{"applicability":"required","items":["ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, International Council for Harmonisation."]},"context":{"applicability":"required","items":["Doravirine is used with other antiretroviral medicines in the treatment of HIV-1 infection.","It is encountered as a pharmaceutical active ingredient, in finished medicines and as a reference material for analytical and pharmaceutical research."]}},"sources":[{"title":"Wikidata item Q6885419: doravirine","url":"https://www.wikidata.org/wiki/Q6885419","note":"identity and sense of the item"},{"title":"Wikipedia: Doravirine","url":"https://en.wikipedia.org/wiki/Doravirine","note":"general description of the item"}],"openQuestions":["Which verified EC or other jurisdictional substance identifiers apply to doravirine, and where is no identifier established?","Which solid forms are relevant to supplied doravirine API, and what validated methods and acceptance limits distinguish them?","What authoritative measurements establish melting or decomposition behaviour, condition-specific solubility and whether a meaningful boiling point is available?","Which current bulk-substance SDS, GHS classifications and occupational exposure limits apply in the intended handling jurisdiction?","Which grade-specific impurity limits, retest periods and storage-excursion criteria are supported by accessible specifications and stability studies?"],"resources":{"spec":"/models/things/publications/thing-q6885419/spec.json"},"provenance":{"origin":"thing registry research (pass 2)","builtFrom":["models/things/publications/thing-q6885419/spec.json"],"providers":["Codex"],"researchStatus":"unreviewed","generatedAt":"2026-09-12T09:17:51Z","builder":"tools/build_cards.py@1.0.0"},"completeness":{"sections":{"classifiers":"filled","whatItIs":"filled","purpose":"filled","distinguishingFeatures":"filled","structure":"filled","agentConduct":"filled","ethics":"filled","owners":"filled","relations":"filled","interaction.identity":"filled","interaction.properties":"filled","interaction.recognition":"filled","interaction.capabilities":"filled","interaction.hazards":"filled","interaction.interfaces":"filled","interaction.context":"filled","sources":"filled"},"notes":{"_gate":"Published through the thing publication gate 1.0 on 2026-10-07T10:10:32+00:00: completeness 1.00; sense: Wikidata description; 2 live sources; review by codex: pass"},"score":1.0}}