ATLPD0000029
Scientific evidence profile for the product as a whole, its reviewed components, PK exposure, clinical context, safety context, and source lineage.
Formulation context: Injection, powder
Product identity and molecular form, PK exposure evidence, safety context, clinical and label context, interpretation boundaries, and reproducibility exits available for this product.
What components make up this product, and which structures are resolved?
What is the drug used for and how does it act?
Are there curated exposure / PK summaries or cited observations?
What safety, postmarketing, and immune-recognition signals surround the product?
What trial and product-label context is attached to this product?
How is the evidence scoped, traced, cited, and reopened?
What the product is, how its complete molecular form is defined, and which chemical or structural representations support that identity.
This record describes a multi-component product. Measurements remain attached to the whole product unless a source explicitly reports an individual component.
These anchors support product-level lookup and context attachment. They are identity evidence, not ADMET endpoint measurements.
ATC classification © WHO Collaborating Centre for Drug Statistics Methodology; used unmodified for non-commercial research.
Measurements on this profile describe the whole product as tested. Reviewed components explain its composition, but they do not inherit the product's endpoint values.
Multi-component product
Component structure not fully resolved. The component relationships below are supported by sources, while exact canonical structures remain unavailable for one or more components.
Product context and measurements remain assigned to the whole product. Specific component identities are shown only where supported by a source.
Whole-product measurements and context are not assigned to an individual component unless the source identifies that component as the measured material.
Component structure not fully resolved. The product is described by its reviewed composition and is not reduced to one peptide structure.
What the drug is used for and how it acts, based on curated therapeutic indications and mechanism-of-action evidence for the product identity.
Traceable exposure and PK properties across product labels, literature, and nonclinical evidence.
Exposure values for the complete multi-component product.
Human product-label values are shown first, followed by additional source-backed evidence.
Human exposure properties reported in official product labeling.
Other source-backed PK properties across labels, literature, and nonclinical studies.
Direct source values extend the product's PK endpoint profile.
| PK property | Value | Context | Reference | Measured material | Evidence role | Reported statement |
|---|---|---|---|---|---|---|
| AUC | 3,185 mg*h/L | human · single 1,000 mg dose | Reference | Whole product | Source-reported product-label value | Dalbavancin Pharmacokinetic Parameters in Healthy Subjects All values are presented as mean (% coefficient of variation) 1 Data from 50 healthy subjects. 2 Data from 12 healthy subjects. 3 Based upon population pharma... |
| AUC | 4,837 mg*h/L | human · single 1,500 mg dose | Reference | Whole product | Source-reported product-label value | Dalbavancin Pharmacokinetic Parameters in Healthy Subjects All values are presented as mean (% coefficient of variation) 1 Data from 50 healthy subjects. 2 Data from 12 healthy subjects. 3 Based upon population pharma... |
| AUC | 11,160 mg*h/L | human · single 1,000 mg dose · healthy subjects | Reference | Whole product | Source-reported product-label value | Dalbavancin Pharmacokinetic Parameters in Healthy Subjects All values are presented as mean (% coefficient of variation) 1 Data from 50 healthy subjects. 2 Data from 12 healthy subjects. 3 Based upon population pharma... |
| AUC | 23,443 mg*h/L | human · single 1,000 mg dose · healthy subjects | Reference | Whole product | Source-reported product-label value | Dalbavancin Pharmacokinetic Parameters in Healthy Subjects All values are presented as mean (% coefficient of variation) 1 Data from 50 healthy subjects. 2 Data from 12 healthy subjects. 3 Based upon population pharma... |
| AUC | The clinical significance of the decrease in mean plasma CL T , and the associated increase in AUC 0-∞ noted in these pharmacokinetic studies of dalbavancin in subjects with CLcr less than 30 mL/min has not been established | human · plasma | Reference | Whole product | Source-reported observation | The clinical significance of the decrease in mean plasma CL T , and the associated increase in AUC 0-∞ noted in these pharmacokinetic studies of dalbavancin in subjects with CLcr less than 30 mL/min has not been estab... |
| AUC | mean AUC 0-336 hrs was unchanged in subjects with mild hepatic impairment compared to subjects with normal hepatic function; however, the mean AUC 0-336 hrs decreased 28% and 31% in subjects with moderate and severe hepatic impairment respectively, compared to subjects with normal hepatic function. | human | Reference | Whole product | Source-reported observation | mean AUC 0-336 hrs was unchanged in subjects with mild hepatic impairment compared to subjects with normal hepatic function; however, the mean AUC 0-336 hrs decreased 28% and 31% in subjects with moderate and severe h... |
| AUC | The median plasma AUC from 0 to 120 hours (AUC 0-120h ) of dalbavancin in pediatric patient age groups from term neonates at birth to less than 18 years is expected to be comparable to that in adult patients (AUC 0-120h , 10,400 mg*h/L). | human · plasma | Reference | Whole product | Source-reported observation | The median plasma AUC from 0 to 120 hours (AUC 0-120h ) of dalbavancin in pediatric patient age groups from term neonates at birth to less than 18 years is expected to be comparable to that in adult patients (AUC 0-12... |
| AUC | The expected median plasma AUC 0-120h of dalbavancin in preterm neonates at birth (gestational age 26 weeks to <37 weeks) was approximately 62% of that in adult patients. | human · plasma | Reference | Whole product | Source-reported observation | The expected median plasma AUC 0-120h of dalbavancin in preterm neonates at birth (gestational age 26 weeks to <37 weeks) was approximately 62% of that in adult patients. |
| AUC | The mean ratio of the AUC 0-144 hrs in skin blister fluid/AUC 0-144 hrs in plasma is 0.60 (range 0.44 to 0.64). | human · plasma | Reference | Whole product | Source-reported observation | The mean ratio of the AUC 0-144 hrs in skin blister fluid/AUC 0-144 hrs in plasma is 0.60 (range 0.44 to 0.64). |
| AUC | In healthy subjects, dalbavancin AUC 0-24h and C max both increased proportionally to dose following single intravenous dalbavancin doses ranging from 140 mg to 1,500 mg, indicating linear pharmacokinetics. | human · intravenous | Reference | Whole product | Source-reported observation | In healthy subjects, dalbavancin AUC 0-24h and C max both increased proportionally to dose following single intravenous dalbavancin doses ranging from 140 mg to 1,500 mg, indicating linear pharmacokinetics. |
Summaries keep species, unit, route, dose, matrix, population, and source context separate. Whole-product values stay attached to the complete product.
Regulatory safety warnings, postmarketing and nonclinical safety context, and immune-recognition context. These describe available signals, not incidence rates or causality.
Clinical-trial context and structured product-label references attached by product identity.
How to read, trace, cite, and reopen this profile: evidence scope, reference lineage, and reproducible data access.
Endpoint summaries, product-context lanes, identity links, and source references answer different questions. This boundary keeps the page useful without converting context into stronger claims than the current review layer supports.
Compare PK results only when endpoint and experimental context are compatible.
Label, trial, safety, immune, and nonclinical records remain contextual unless separately extracted as an endpoint.
Components do not inherit product measurements.
Comparable measurement layer
Endpoint-level interpretation when context fields match.
Pooled product parameters across mismatched species, units, route, dose, matrix, population, or source context.
Clinical, label, safety, immune, and nonclinical context
Reading the product's evidence surroundings and source-backed context lanes.
Incidence rates, causality claims, product safety ranking, or normalized ADMET endpoint values.
Measured-material boundary
Describing source-supported components while retaining measurements at whole-product level.
Transfer of a whole-product result to one component.
Reproducibility and source trace
Checking where labels, trials, safety reports, identity links, and curated measurements came from.
A substitute for normalized evidence, context grouping, or endpoint review.
Original-source reading path
Reading the source reference in its native regulatory, registry, literature, or source context.
Bypassing ADMETatlas curation status, interpretation boundaries, or endpoint-promotion policy.
Label, trial, safety, immune, identity-link, and PK evidence enter the product profile through different review paths. This module keeps their roles visible so users can trace evidence without over-reading context counts.
active reference families
source-matching traces
PK plus context entries
current product profile
Regulatory product-label context
Label sections, label-derived PK statements, safety wording, route, formulation, and immunogenicity context when extracted.
Label material supports product context. It becomes endpoint evidence only through the reviewed PK or endpoint extraction path.
Human study-registration context
Trial identity, phase/status, intervention matching, and availability of results context around the product.
Trial registry entries are study context unless endpoint-compatible results are extracted and reviewed separately.
Safety surveillance context
Signal-aware reading of reported adverse-event context around marketed products.
Report counts do not establish causality, incidence, or comparative product safety.
Assay and nonclinical support context
Immune-recognition assays, nonclinical safety context, and neighboring signals that help interpret the product profile.
These entries are not clinical incidence or endpoint truth unless a review policy promotes a specific endpoint.
Named-product identity support
Matching named and dosed product presentations to a stable medication identity.
Identity records do not provide an endpoint value, administration outcome, or route-specific clinical result.
Source-matching and identity-review context
Source records used to assess product-to-peptide identity relationships and retained audit context.
Only an exact match to the current authoritative canonical identity supports a linked identity; all other traces remain product context.
Endpoint measurement trace
Rechecking source values, units, route, dose, matrix, population, and source context for PK summaries.
PK entries remain context-bound measurements and should not be pooled across incompatible contexts.
Link references and selected label entries carry direct source links. Product-context entries may instead carry source labels and curated summaries in the structured profile. Both are provenance, but only direct reference fields should be displayed as citation links.
The structured profile access reopens the same product view used by this page, including molecular identity, PK evidence, product context, and reference lineage for the current public release.
public product profile
identity link scope
cited measurement trace
25 context · 2 identity support
label plus link traces
Use the product profile access for product-specific reproducibility. Use full-release downloads for catalog-scale analysis, with the current source policy and data dictionary.
Current product
Machine-readable profile for molecular identity, PK evidence summaries, product context, and reference lineage.
Uses the public ATL product ID in the URL. Non-public product identifiers remain outside the navigation label.
The request returns the structured product profile used by this page. It is the current product-specific reproducibility path while product-only tabular exports remain a release follow-up.
curl -sS 'https://admetatlas.scbdd.com/api/v1/products/ATLPD0000029' \
-H 'accept: application/json' \
-H 'X-Visibility: public_release'Use this module to reproduce the current product profile and locate full-release exports. Cross-product comparison still depends on compatible endpoint, species, route, dose, matrix, population, source, identity-link, and review context.