The FDA and the New Biology View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2008-09-23

AUTHORS

Robert D. Simari, Horng Chen, John C. Burnett

ABSTRACT

The translation of basic science discoveries to clinical application is dependent on the demonstrated efficacy in humans of the technology but even as importantly on the therapeutic agent or device conforming to the standards of the US Food and Drug Administration (FDA) leading to approval. In this editorial, we propose that the FDA consider a modified process to support the more rapid development of novel agents while furthering the understanding of the risk and benefits of new therapeutics as they are utilized following approval. More... »

PAGES

246-247

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12265-008-9060-y

DOI

http://dx.doi.org/10.1007/s12265-008-9060-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1037706087

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/20559929


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/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1199", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Other Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Biology", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Cardiovascular Diseases", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Chest Pain", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Chronic Disease", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Approval", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Endothelium, Vascular", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Genomics", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Microcirculation", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Proteomics", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Translational Medical Research", 
        "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"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Ventricular Remodeling", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA", 
          "id": "http://www.grid.ac/institutes/grid.66875.3a", 
          "name": [
            "Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Simari", 
        "givenName": "Robert D.", 
        "id": "sg:person.0604514740.51", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0604514740.51"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA", 
          "id": "http://www.grid.ac/institutes/grid.66875.3a", 
          "name": [
            "Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Chen", 
        "givenName": "Horng", 
        "id": "sg:person.01024326700.50", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01024326700.50"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA", 
          "id": "http://www.grid.ac/institutes/grid.66875.3a", 
          "name": [
            "Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Burnett", 
        "givenName": "John C.", 
        "id": "sg:person.01001266776.01", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01001266776.01"
        ], 
        "type": "Person"
      }
    ], 
    "datePublished": "2008-09-23", 
    "datePublishedReg": "2008-09-23", 
    "description": "The translation of basic science discoveries to clinical application is dependent on the demonstrated efficacy in humans of the technology but even as importantly on the therapeutic agent or device conforming to the standards of the US Food and Drug Administration (FDA) leading to approval. In this editorial, we propose that the FDA consider a modified process to support the more rapid development of novel agents while furthering the understanding of the risk and benefits of new therapeutics as they are utilized following approval.", 
    "genre": "article", 
    "id": "sg:pub.10.1007/s12265-008-9060-y", 
    "inLanguage": "en", 
    "isAccessibleForFree": false, 
    "isPartOf": [
      {
        "id": "sg:journal.1039754", 
        "issn": [
          "1937-5387", 
          "1937-5395"
        ], 
        "name": "Journal of Cardiovascular Translational Research", 
        "publisher": "Springer Nature", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "4", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "1"
      }
    ], 
    "keywords": [
      "basic science discoveries", 
      "novel agents", 
      "US Food", 
      "Drug Administration", 
      "therapeutic agents", 
      "new therapeutics", 
      "clinical applications", 
      "FDA", 
      "science discoveries", 
      "approval", 
      "agents", 
      "administration", 
      "efficacy", 
      "risk", 
      "therapeutics", 
      "new biology", 
      "humans", 
      "food", 
      "benefits", 
      "development", 
      "biology", 
      "standards", 
      "editorial", 
      "discovery", 
      "understanding", 
      "translation", 
      "rapid development", 
      "devices", 
      "process", 
      "applications", 
      "technology"
    ], 
    "name": "The FDA and the New Biology", 
    "pagination": "246-247", 
    "productId": [
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1037706087"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1007/s12265-008-9060-y"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "20559929"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1007/s12265-008-9060-y", 
      "https://app.dimensions.ai/details/publication/pub.1037706087"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2022-01-01T18:18", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20220101/entities/gbq_results/article/article_460.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://doi.org/10.1007/s12265-008-9060-y"
  }
]
 

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.10.1007/s12265-008-9060-y'

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

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s12265-008-9060-y'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s12265-008-9060-y'

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

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s12265-008-9060-y'


 

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

163 TRIPLES      21 PREDICATES      71 URIs      63 LITERALS      21 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1007/s12265-008-9060-y schema:about N0214b2455a584a5d9f57634286d3702c
2 N0dfa17a6e7ef47cb8b247891f0a56953
3 N139314b611df4a05802671852bc5fa4a
4 N268430f7c6a046ba8a983bb9fb759b95
5 N88a369405d764ef08524337c027f493a
6 N8b96522ab00f46dc96eb1d3407899249
7 N9e43dfe757714fcabc2cba3e7fd4d42e
8 Na465107be2f24690a321f1c0709f9591
9 Naef45da461f84f22bf680056544806cf
10 Nb4796d708989475e9f2030766af2f7c8
11 Nc7c4660d8ea04972984f91af4ef46099
12 Nde5e51e65f2247edb667107dad6cccf8
13 Ne93d228e178648e6a6f3f955470556d9
14 Nea5488650c6746c5ad0195a7480930fe
15 anzsrc-for:11
16 anzsrc-for:1199
17 schema:author N6d583a957e95403bbb7c0aa0851963db
18 schema:datePublished 2008-09-23
19 schema:datePublishedReg 2008-09-23
20 schema:description The translation of basic science discoveries to clinical application is dependent on the demonstrated efficacy in humans of the technology but even as importantly on the therapeutic agent or device conforming to the standards of the US Food and Drug Administration (FDA) leading to approval. In this editorial, we propose that the FDA consider a modified process to support the more rapid development of novel agents while furthering the understanding of the risk and benefits of new therapeutics as they are utilized following approval.
21 schema:genre article
22 schema:inLanguage en
23 schema:isAccessibleForFree false
24 schema:isPartOf N0acb1270c96f44dc9ee44e897b460c37
25 Nad347885203d41959559560ee039167c
26 sg:journal.1039754
27 schema:keywords Drug Administration
28 FDA
29 US Food
30 administration
31 agents
32 applications
33 approval
34 basic science discoveries
35 benefits
36 biology
37 clinical applications
38 development
39 devices
40 discovery
41 editorial
42 efficacy
43 food
44 humans
45 new biology
46 new therapeutics
47 novel agents
48 process
49 rapid development
50 risk
51 science discoveries
52 standards
53 technology
54 therapeutic agents
55 therapeutics
56 translation
57 understanding
58 schema:name The FDA and the New Biology
59 schema:pagination 246-247
60 schema:productId N229e9ff09a904146aa1db93797d793a1
61 N4f9d27946c67445d85569927388b2083
62 N84b0a7fef7764e5382b7c1bc2d4b6652
63 schema:sameAs https://app.dimensions.ai/details/publication/pub.1037706087
64 https://doi.org/10.1007/s12265-008-9060-y
65 schema:sdDatePublished 2022-01-01T18:18
66 schema:sdLicense https://scigraph.springernature.com/explorer/license/
67 schema:sdPublisher N34515b6cb4d84bada167ce253598fd72
68 schema:url https://doi.org/10.1007/s12265-008-9060-y
69 sgo:license sg:explorer/license/
70 sgo:sdDataset articles
71 rdf:type schema:ScholarlyArticle
72 N0214b2455a584a5d9f57634286d3702c schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
73 schema:name Proteomics
74 rdf:type schema:DefinedTerm
75 N0acb1270c96f44dc9ee44e897b460c37 schema:volumeNumber 1
76 rdf:type schema:PublicationVolume
77 N0dfa17a6e7ef47cb8b247891f0a56953 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
78 schema:name Biology
79 rdf:type schema:DefinedTerm
80 N139314b611df4a05802671852bc5fa4a schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
81 schema:name Translational Medical Research
82 rdf:type schema:DefinedTerm
83 N229e9ff09a904146aa1db93797d793a1 schema:name dimensions_id
84 schema:value pub.1037706087
85 rdf:type schema:PropertyValue
86 N268430f7c6a046ba8a983bb9fb759b95 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
87 schema:name Ventricular Remodeling
88 rdf:type schema:DefinedTerm
89 N34515b6cb4d84bada167ce253598fd72 schema:name Springer Nature - SN SciGraph project
90 rdf:type schema:Organization
91 N4f9d27946c67445d85569927388b2083 schema:name doi
92 schema:value 10.1007/s12265-008-9060-y
93 rdf:type schema:PropertyValue
94 N63572c5fc2074019bc71cf54c69d4bc1 rdf:first sg:person.01024326700.50
95 rdf:rest Nb0ef84a76dd142d58062dc023339297b
96 N6d583a957e95403bbb7c0aa0851963db rdf:first sg:person.0604514740.51
97 rdf:rest N63572c5fc2074019bc71cf54c69d4bc1
98 N84b0a7fef7764e5382b7c1bc2d4b6652 schema:name pubmed_id
99 schema:value 20559929
100 rdf:type schema:PropertyValue
101 N88a369405d764ef08524337c027f493a schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
102 schema:name Cardiovascular Diseases
103 rdf:type schema:DefinedTerm
104 N8b96522ab00f46dc96eb1d3407899249 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
105 schema:name Drug Approval
106 rdf:type schema:DefinedTerm
107 N9e43dfe757714fcabc2cba3e7fd4d42e schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
108 schema:name Humans
109 rdf:type schema:DefinedTerm
110 Na465107be2f24690a321f1c0709f9591 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
111 schema:name Microcirculation
112 rdf:type schema:DefinedTerm
113 Nad347885203d41959559560ee039167c schema:issueNumber 4
114 rdf:type schema:PublicationIssue
115 Naef45da461f84f22bf680056544806cf schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
116 schema:name Genomics
117 rdf:type schema:DefinedTerm
118 Nb0ef84a76dd142d58062dc023339297b rdf:first sg:person.01001266776.01
119 rdf:rest rdf:nil
120 Nb4796d708989475e9f2030766af2f7c8 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
121 schema:name United States
122 rdf:type schema:DefinedTerm
123 Nc7c4660d8ea04972984f91af4ef46099 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
124 schema:name Endothelium, Vascular
125 rdf:type schema:DefinedTerm
126 Nde5e51e65f2247edb667107dad6cccf8 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
127 schema:name Chronic Disease
128 rdf:type schema:DefinedTerm
129 Ne93d228e178648e6a6f3f955470556d9 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
130 schema:name United States Food and Drug Administration
131 rdf:type schema:DefinedTerm
132 Nea5488650c6746c5ad0195a7480930fe schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
133 schema:name Chest Pain
134 rdf:type schema:DefinedTerm
135 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
136 schema:name Medical and Health Sciences
137 rdf:type schema:DefinedTerm
138 anzsrc-for:1199 schema:inDefinedTermSet anzsrc-for:
139 schema:name Other Medical and Health Sciences
140 rdf:type schema:DefinedTerm
141 sg:journal.1039754 schema:issn 1937-5387
142 1937-5395
143 schema:name Journal of Cardiovascular Translational Research
144 schema:publisher Springer Nature
145 rdf:type schema:Periodical
146 sg:person.01001266776.01 schema:affiliation grid-institutes:grid.66875.3a
147 schema:familyName Burnett
148 schema:givenName John C.
149 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01001266776.01
150 rdf:type schema:Person
151 sg:person.01024326700.50 schema:affiliation grid-institutes:grid.66875.3a
152 schema:familyName Chen
153 schema:givenName Horng
154 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01024326700.50
155 rdf:type schema:Person
156 sg:person.0604514740.51 schema:affiliation grid-institutes:grid.66875.3a
157 schema:familyName Simari
158 schema:givenName Robert D.
159 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0604514740.51
160 rdf:type schema:Person
161 grid-institutes:grid.66875.3a schema:alternateName Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA
162 schema:name Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA
163 rdf:type schema:Organization
 




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


...