The Product Label View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2002-03

AUTHORS

Patrick J. Marroum, Jogarao Gobburu

ABSTRACT

The product label, or package insert, is the 'manual' for the safe and effective use of a drug. Important pharmacokinetic and pharmacodynamic properties of a drug product should appear in the label under specific sections, as required in the Code of Federal Regulations (CFR), using a format and language recommended by the Food and Drug Administration (FDA) in various guidances to the industry. The relevant regulations and guidance documents impacting on how this information is conveyed to the healthcare professional are discussed, with special emphasis on how the new proposed rule will impact upon how information is to be conveyed. With the availability of new clinical pharmacology information not available at the time of approval, package inserts for older drugs should be updated to reflect the new data and recommend the proper dosage regimen, enabling prescribers to optimise drug therapy and minimise possible adverse events. More... »

PAGES

161-169

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.2165/00003088-200241030-00001

DOI

http://dx.doi.org/10.2165/00003088-200241030-00001

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1020047502

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/11929317


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1117", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Public Health and Health Services", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Approval", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Industry", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Interactions", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Labeling", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Prescriptions", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Pharmacokinetics", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Pharmacology, Clinical", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Physician's Role", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "United States", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "United States Food and Drug Administration", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Division of Pharmaceutical Evaluation, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Marroum", 
        "givenName": "Patrick J.", 
        "id": "sg:person.0722617647.20", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0722617647.20"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Division of Pharmaceutical Evaluation, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Gobburu", 
        "givenName": "Jogarao", 
        "id": "sg:person.012374137767.79", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012374137767.79"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1016/s0009-9236(99)70048-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1025509950", 
          "https://doi.org/10.1016/s0009-9236(99)70048-2"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1067/mcp.2000.104737", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1039972648", 
          "https://doi.org/10.1067/mcp.2000.104737"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/clpt.1992.47", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041049065", 
          "https://doi.org/10.1038/clpt.1992.47"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2002-03", 
    "datePublishedReg": "2002-03-01", 
    "description": "The product label, or package insert, is the 'manual' for the safe and effective use of a drug. Important pharmacokinetic and pharmacodynamic properties of a drug product should appear in the label under specific sections, as required in the Code of Federal Regulations (CFR), using a format and language recommended by the Food and Drug Administration (FDA) in various guidances to the industry. The relevant regulations and guidance documents impacting on how this information is conveyed to the healthcare professional are discussed, with special emphasis on how the new proposed rule will impact upon how information is to be conveyed. With the availability of new clinical pharmacology information not available at the time of approval, package inserts for older drugs should be updated to reflect the new data and recommend the proper dosage regimen, enabling prescribers to optimise drug therapy and minimise possible adverse events.", 
    "genre": "research_article", 
    "id": "sg:pub.10.2165/00003088-200241030-00001", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": false, 
    "isPartOf": [
      {
        "id": "sg:journal.1085321", 
        "issn": [
          "0312-5963", 
          "1179-1926"
        ], 
        "name": "Clinical Pharmacokinetics", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "3", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "41"
      }
    ], 
    "name": "The Product Label", 
    "pagination": "161-169", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "5f8495ec07c0a8b361ac17c0e1ec0718346d7116162a5b69da452cf57e0fc8d0"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "11929317"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "7606849"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.2165/00003088-200241030-00001"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1020047502"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.2165/00003088-200241030-00001", 
      "https://app.dimensions.ai/details/publication/pub.1020047502"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-11T12:35", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000363_0000000363/records_70028_00000000.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "http://link.springer.com/10.2165/00003088-200241030-00001"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.2165/00003088-200241030-00001'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.2165/00003088-200241030-00001'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.2165/00003088-200241030-00001'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.2165/00003088-200241030-00001'


 

This table displays all metadata directly associated to this object as RDF triples.

132 TRIPLES      21 PREDICATES      43 URIs      32 LITERALS      20 BLANK NODES

Subject Predicate Object
1 sg:pub.10.2165/00003088-200241030-00001 schema:about N192f54b244214ec48e5d8c074507220c
2 N20aa1e85eb6147a6a5a562c1784b9dda
3 N4e6d2505de4a4185b62b66b329886816
4 N703676b27bc54126ad99b23e9b1ecd11
5 N730b53dd442c420fa7cae7d7075d99de
6 N7ae001e3c8d549f98f0373cce80ae4c9
7 N8535d5a058894e9e877ca02d7243109a
8 N959cdc3105874dcaacc2205cad0c9812
9 Na1db5346fd694c5b91bc3275676749c8
10 Nb458555ea243457c830d6d278947c851
11 Nd1fa1fb568fb4c7092979eac4ebd9414
12 anzsrc-for:11
13 anzsrc-for:1117
14 schema:author N910a51538fc6460eaa6d3bddad7c054f
15 schema:citation sg:pub.10.1016/s0009-9236(99)70048-2
16 sg:pub.10.1038/clpt.1992.47
17 sg:pub.10.1067/mcp.2000.104737
18 schema:datePublished 2002-03
19 schema:datePublishedReg 2002-03-01
20 schema:description The product label, or package insert, is the 'manual' for the safe and effective use of a drug. Important pharmacokinetic and pharmacodynamic properties of a drug product should appear in the label under specific sections, as required in the Code of Federal Regulations (CFR), using a format and language recommended by the Food and Drug Administration (FDA) in various guidances to the industry. The relevant regulations and guidance documents impacting on how this information is conveyed to the healthcare professional are discussed, with special emphasis on how the new proposed rule will impact upon how information is to be conveyed. With the availability of new clinical pharmacology information not available at the time of approval, package inserts for older drugs should be updated to reflect the new data and recommend the proper dosage regimen, enabling prescribers to optimise drug therapy and minimise possible adverse events.
21 schema:genre research_article
22 schema:inLanguage en
23 schema:isAccessibleForFree false
24 schema:isPartOf N9648b8360fd9450aa6ac1e6e436e9d3a
25 Nb49af2ca3d3c488780e9895eab296b36
26 sg:journal.1085321
27 schema:name The Product Label
28 schema:pagination 161-169
29 schema:productId N6dd8e5cfd94a4e5bbd9afbbb9261cc00
30 N7d2a43972ab745fc9647c420d38630a6
31 N838968f7f98545a79586b45615f4dc49
32 Ncacabd29e4a74a2195c705d08012ba20
33 Nfe071a35a5814b3d970b3827f91911d6
34 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020047502
35 https://doi.org/10.2165/00003088-200241030-00001
36 schema:sdDatePublished 2019-04-11T12:35
37 schema:sdLicense https://scigraph.springernature.com/explorer/license/
38 schema:sdPublisher N54d3da94dd08425e956e4bbf7f5c3997
39 schema:url http://link.springer.com/10.2165/00003088-200241030-00001
40 sgo:license sg:explorer/license/
41 sgo:sdDataset articles
42 rdf:type schema:ScholarlyArticle
43 N192f54b244214ec48e5d8c074507220c schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
44 schema:name Physician's Role
45 rdf:type schema:DefinedTerm
46 N20aa1e85eb6147a6a5a562c1784b9dda schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
47 schema:name Drug Interactions
48 rdf:type schema:DefinedTerm
49 N4e6d2505de4a4185b62b66b329886816 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
50 schema:name Drug Prescriptions
51 rdf:type schema:DefinedTerm
52 N54d3da94dd08425e956e4bbf7f5c3997 schema:name Springer Nature - SN SciGraph project
53 rdf:type schema:Organization
54 N6dd8e5cfd94a4e5bbd9afbbb9261cc00 schema:name nlm_unique_id
55 schema:value 7606849
56 rdf:type schema:PropertyValue
57 N703676b27bc54126ad99b23e9b1ecd11 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
58 schema:name Pharmacology, Clinical
59 rdf:type schema:DefinedTerm
60 N730b53dd442c420fa7cae7d7075d99de schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
61 schema:name Humans
62 rdf:type schema:DefinedTerm
63 N7ae001e3c8d549f98f0373cce80ae4c9 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
64 schema:name United States
65 rdf:type schema:DefinedTerm
66 N7d2a43972ab745fc9647c420d38630a6 schema:name readcube_id
67 schema:value 5f8495ec07c0a8b361ac17c0e1ec0718346d7116162a5b69da452cf57e0fc8d0
68 rdf:type schema:PropertyValue
69 N838968f7f98545a79586b45615f4dc49 schema:name pubmed_id
70 schema:value 11929317
71 rdf:type schema:PropertyValue
72 N8535d5a058894e9e877ca02d7243109a schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
73 schema:name Drug Approval
74 rdf:type schema:DefinedTerm
75 N8c96fc6f547a4458a066ed1a43702c72 rdf:first sg:person.012374137767.79
76 rdf:rest rdf:nil
77 N910a51538fc6460eaa6d3bddad7c054f rdf:first sg:person.0722617647.20
78 rdf:rest N8c96fc6f547a4458a066ed1a43702c72
79 N959cdc3105874dcaacc2205cad0c9812 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
80 schema:name Drug Industry
81 rdf:type schema:DefinedTerm
82 N9648b8360fd9450aa6ac1e6e436e9d3a schema:issueNumber 3
83 rdf:type schema:PublicationIssue
84 Na1db5346fd694c5b91bc3275676749c8 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
85 schema:name Drug Labeling
86 rdf:type schema:DefinedTerm
87 Nb458555ea243457c830d6d278947c851 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
88 schema:name United States Food and Drug Administration
89 rdf:type schema:DefinedTerm
90 Nb49af2ca3d3c488780e9895eab296b36 schema:volumeNumber 41
91 rdf:type schema:PublicationVolume
92 Ncacabd29e4a74a2195c705d08012ba20 schema:name doi
93 schema:value 10.2165/00003088-200241030-00001
94 rdf:type schema:PropertyValue
95 Nd1fa1fb568fb4c7092979eac4ebd9414 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
96 schema:name Pharmacokinetics
97 rdf:type schema:DefinedTerm
98 Nfe071a35a5814b3d970b3827f91911d6 schema:name dimensions_id
99 schema:value pub.1020047502
100 rdf:type schema:PropertyValue
101 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
102 schema:name Medical and Health Sciences
103 rdf:type schema:DefinedTerm
104 anzsrc-for:1117 schema:inDefinedTermSet anzsrc-for:
105 schema:name Public Health and Health Services
106 rdf:type schema:DefinedTerm
107 sg:journal.1085321 schema:issn 0312-5963
108 1179-1926
109 schema:name Clinical Pharmacokinetics
110 rdf:type schema:Periodical
111 sg:person.012374137767.79 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
112 schema:familyName Gobburu
113 schema:givenName Jogarao
114 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012374137767.79
115 rdf:type schema:Person
116 sg:person.0722617647.20 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
117 schema:familyName Marroum
118 schema:givenName Patrick J.
119 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0722617647.20
120 rdf:type schema:Person
121 sg:pub.10.1016/s0009-9236(99)70048-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1025509950
122 https://doi.org/10.1016/s0009-9236(99)70048-2
123 rdf:type schema:CreativeWork
124 sg:pub.10.1038/clpt.1992.47 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041049065
125 https://doi.org/10.1038/clpt.1992.47
126 rdf:type schema:CreativeWork
127 sg:pub.10.1067/mcp.2000.104737 schema:sameAs https://app.dimensions.ai/details/publication/pub.1039972648
128 https://doi.org/10.1067/mcp.2000.104737
129 rdf:type schema:CreativeWork
130 https://www.grid.ac/institutes/grid.483500.a schema:alternateName Center for Drug Evaluation and Research
131 schema:name Division of Pharmaceutical Evaluation, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA
132 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...