Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2006-12

AUTHORS

U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health

ABSTRACT

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006. More... »

PAGES

79

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1477-7525-4-79

DOI

http://dx.doi.org/10.1186/1477-7525-4-79

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1050813769

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/17034633


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": "Clinical Trials as Topic", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Data Interpretation, Statistical", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Industry", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Guidelines as Topic", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Pain Measurement", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Patient Satisfaction", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Product Labeling", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Psychometrics", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Quality of Life", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Surveys and Questionnaires", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Treatment Outcome", 
        "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": "Montgomery County Department of Health and Human Services", 
          "id": "https://www.grid.ac/institutes/grid.414212.0", 
          "name": [
            "U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, 2085, Rockville, MD, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Montgomery County Department of Health and Human Services", 
          "id": "https://www.grid.ac/institutes/grid.414212.0", 
          "name": [
            "U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, 20852-1448, Rockville, MD, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, 20850-430, Rockville, MD, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health", 
        "type": "Person"
      }
    ], 
    "datePublished": "2006-12", 
    "datePublishedReg": "2006-12-01", 
    "description": "This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1186/1477-7525-4-79", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": true, 
    "isPartOf": [
      {
        "id": "sg:journal.1031326", 
        "issn": [
          "1477-7525"
        ], 
        "name": "Health and Quality of Life Outcomes", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "4"
      }
    ], 
    "name": "Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance", 
    "pagination": "79", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "f20e7b9f76632806fc808e60c7089143d866a7d8b4d41a8ccdfa40b804a67ace"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "17034633"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "101153626"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/1477-7525-4-79"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1050813769"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/1477-7525-4-79", 
      "https://app.dimensions.ai/details/publication/pub.1050813769"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-10T19:58", 
    "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/v90/0000000001_0000000264/records_8681_00000516.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "http://link.springer.com/10.1186%2F1477-7525-4-79"
  }
]
 

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.10.1186/1477-7525-4-79'

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

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/1477-7525-4-79'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/1477-7525-4-79'

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

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/1477-7525-4-79'


 

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

135 TRIPLES      20 PREDICATES      43 URIs      35 LITERALS      23 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/1477-7525-4-79 schema:about N204525a208164b9b900063f7cc145e41
2 N21069a6cf070491ba1445aa6232902b1
3 N210e52b93a63456399b13d3436759643
4 N3ce669b36cda480d801fc35c7d297263
5 N4c96e52eb1da43468c5f14d26854ef59
6 N726e892471474441afbec89429f5850d
7 N8f3dfd8d05cb4f18a24ac2fe3dd3b01f
8 N9e5bc0684cac4496bf4d5e9d5c66924c
9 Nc1254c056c174c2392b91754cb13413f
10 Nd6b6e10cf99a43308711faa204b18fca
11 Ndccd70ce937f4fe395b6201a67865fc0
12 Nf0c85a75e0e54ed285b72d611592be85
13 Nfb1d7022a0024585a4a4fdc22a6bddb3
14 Nff4da86957db4eff9d4a0981bbfa4e6d
15 anzsrc-for:11
16 anzsrc-for:1117
17 schema:author Neec9d9df80fe48ce9609c52c045db26f
18 schema:datePublished 2006-12
19 schema:datePublishedReg 2006-12-01
20 schema:description This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.
21 schema:genre research_article
22 schema:inLanguage en
23 schema:isAccessibleForFree true
24 schema:isPartOf N2fe385b48b084d22935610661cc06372
25 N86de0f3547f94bb99095c03837787c9f
26 sg:journal.1031326
27 schema:name Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
28 schema:pagination 79
29 schema:productId N5f4741b4718e4234b446694f9a694288
30 N85ca914d9cf948a399627419c0c64edc
31 Nd0ac7350e4c24536974267049a9e360e
32 Ne11851e7527f47a7ab6ea93a4593bd86
33 Nf5d8aa697570414b9deba624afa135ef
34 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050813769
35 https://doi.org/10.1186/1477-7525-4-79
36 schema:sdDatePublished 2019-04-10T19:58
37 schema:sdLicense https://scigraph.springernature.com/explorer/license/
38 schema:sdPublisher N70aab97399be47c78410933d08cb6d12
39 schema:url http://link.springer.com/10.1186%2F1477-7525-4-79
40 sgo:license sg:explorer/license/
41 sgo:sdDataset articles
42 rdf:type schema:ScholarlyArticle
43 N0b10901dd18a4c3aa13d54ed303e73cc rdf:first N0bbd94253c5e4d308f7c32ea631acbdb
44 rdf:rest rdf:nil
45 N0bbd94253c5e4d308f7c32ea631acbdb schema:affiliation Nc3fd642b160b419aae4eb2c889ceebc5
46 schema:familyName U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health
47 rdf:type schema:Person
48 N0fd934f252b044aeb1d891d63ebfe8ee schema:affiliation https://www.grid.ac/institutes/grid.414212.0
49 schema:familyName U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research
50 rdf:type schema:Person
51 N204525a208164b9b900063f7cc145e41 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
52 schema:name Humans
53 rdf:type schema:DefinedTerm
54 N21069a6cf070491ba1445aa6232902b1 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
55 schema:name Data Interpretation, Statistical
56 rdf:type schema:DefinedTerm
57 N210e52b93a63456399b13d3436759643 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
58 schema:name Patient Satisfaction
59 rdf:type schema:DefinedTerm
60 N2fe385b48b084d22935610661cc06372 schema:issueNumber 1
61 rdf:type schema:PublicationIssue
62 N3ce669b36cda480d801fc35c7d297263 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
63 schema:name Product Labeling
64 rdf:type schema:DefinedTerm
65 N4c96e52eb1da43468c5f14d26854ef59 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
66 schema:name Surveys and Questionnaires
67 rdf:type schema:DefinedTerm
68 N5f4741b4718e4234b446694f9a694288 schema:name readcube_id
69 schema:value f20e7b9f76632806fc808e60c7089143d866a7d8b4d41a8ccdfa40b804a67ace
70 rdf:type schema:PropertyValue
71 N70aab97399be47c78410933d08cb6d12 schema:name Springer Nature - SN SciGraph project
72 rdf:type schema:Organization
73 N726e892471474441afbec89429f5850d schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
74 schema:name Drug Industry
75 rdf:type schema:DefinedTerm
76 N85ca914d9cf948a399627419c0c64edc schema:name pubmed_id
77 schema:value 17034633
78 rdf:type schema:PropertyValue
79 N86de0f3547f94bb99095c03837787c9f schema:volumeNumber 4
80 rdf:type schema:PublicationVolume
81 N8c56312c279b47d9907f95968db2ed7a rdf:first Neba91e9429fa42e2838c02660ece48c0
82 rdf:rest N0b10901dd18a4c3aa13d54ed303e73cc
83 N8f3dfd8d05cb4f18a24ac2fe3dd3b01f schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
84 schema:name Pain Measurement
85 rdf:type schema:DefinedTerm
86 N9e5bc0684cac4496bf4d5e9d5c66924c schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
87 schema:name Psychometrics
88 rdf:type schema:DefinedTerm
89 Nc1254c056c174c2392b91754cb13413f schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
90 schema:name United States
91 rdf:type schema:DefinedTerm
92 Nc3fd642b160b419aae4eb2c889ceebc5 schema:name U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, 20850-430, Rockville, MD, USA
93 rdf:type schema:Organization
94 Nd0ac7350e4c24536974267049a9e360e schema:name nlm_unique_id
95 schema:value 101153626
96 rdf:type schema:PropertyValue
97 Nd6b6e10cf99a43308711faa204b18fca schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
98 schema:name Guidelines as Topic
99 rdf:type schema:DefinedTerm
100 Ndccd70ce937f4fe395b6201a67865fc0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
101 schema:name Clinical Trials as Topic
102 rdf:type schema:DefinedTerm
103 Ne11851e7527f47a7ab6ea93a4593bd86 schema:name doi
104 schema:value 10.1186/1477-7525-4-79
105 rdf:type schema:PropertyValue
106 Neba91e9429fa42e2838c02660ece48c0 schema:affiliation https://www.grid.ac/institutes/grid.414212.0
107 schema:familyName U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research
108 rdf:type schema:Person
109 Neec9d9df80fe48ce9609c52c045db26f rdf:first N0fd934f252b044aeb1d891d63ebfe8ee
110 rdf:rest N8c56312c279b47d9907f95968db2ed7a
111 Nf0c85a75e0e54ed285b72d611592be85 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
112 schema:name United States Food and Drug Administration
113 rdf:type schema:DefinedTerm
114 Nf5d8aa697570414b9deba624afa135ef schema:name dimensions_id
115 schema:value pub.1050813769
116 rdf:type schema:PropertyValue
117 Nfb1d7022a0024585a4a4fdc22a6bddb3 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
118 schema:name Quality of Life
119 rdf:type schema:DefinedTerm
120 Nff4da86957db4eff9d4a0981bbfa4e6d schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
121 schema:name Treatment Outcome
122 rdf:type schema:DefinedTerm
123 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
124 schema:name Medical and Health Sciences
125 rdf:type schema:DefinedTerm
126 anzsrc-for:1117 schema:inDefinedTermSet anzsrc-for:
127 schema:name Public Health and Health Services
128 rdf:type schema:DefinedTerm
129 sg:journal.1031326 schema:issn 1477-7525
130 schema:name Health and Quality of Life Outcomes
131 rdf:type schema:Periodical
132 https://www.grid.ac/institutes/grid.414212.0 schema:alternateName Montgomery County Department of Health and Human Services
133 schema:name U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, 20852-1448, Rockville, MD, USA
134 U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, 2085, Rockville, MD, USA
135 rdf:type schema:Organization
 




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


...