Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-03

AUTHORS

Qing Liu, Mohammad Absar, Bhawana Saluja, Changning Guo, Badrul Chowdhury, Robert Lionberger, Dale P. Conner, Bing V. Li

ABSTRACT

In 2016, the US Food and Drug Administration (FDA) approved the first Abbreviated New Drug Application for Mometasone Furoate Nasal Suspension Spray. To establish the bioequivalence of this generic nasal suspension spray with the reference listed drug product (RLD), Nasonex®, a "weight-of-evidence" approach was utilized by the applicant that included formulation and device similarities, equivalent in vitro performance, equivalent systemic exposure, and equivalent local delivery. In addition to these testing for comprehensive evaluation of the drug product, FDA also considered supportive data generated by a novel in vitro method, Morphologically-Directed Raman Spectroscopy (MDRS), to characterize the particle size distribution (PSD) of active pharmaceutical ingredient (API) in the drug product. In this case, MDRS data eliminated the need for a comparative clinical endpoint bioequivalence study. The approval of the first generic Mometasone Furoate Nasal Suspension Spray is precedent-setting and paves a new pathway to establish bioequivalence for generic nasal suspension sprays. This approval also exemplifies FDA's commitment to advance regulatory science for evaluation of generic drug products. More... »

PAGES

14

Identifiers

URI

http://scigraph.springernature.com/pub.10.1208/s12248-018-0283-9

DOI

http://dx.doi.org/10.1208/s12248-018-0283-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111225255

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30617594


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/2008/1115", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Pharmacology and Pharmaceutical Sciences", 
        "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"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Liu", 
        "givenName": "Qing", 
        "id": "sg:person.01026141541.20", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01026141541.20"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA", 
            "Office of Translational Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Absar", 
        "givenName": "Mohammad", 
        "id": "sg:person.0616556757.03", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0616556757.03"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA", 
            "Office of Translational Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Saluja", 
        "givenName": "Bhawana", 
        "id": "sg:person.0742074506.93", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0742074506.93"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Guo", 
        "givenName": "Changning", 
        "id": "sg:person.0671167607.21", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0671167607.21"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "AstraZeneca (United States)", 
          "id": "https://www.grid.ac/institutes/grid.418152.b", 
          "name": [
            "Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA", 
            "Respiratory, Inflammation and Autoimmunity, Medimmune, AstraZeneca Pharmaceuticals, Gaithersburg, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Chowdhury", 
        "givenName": "Badrul", 
        "id": "sg:person.0640344526.53", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0640344526.53"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Lionberger", 
        "givenName": "Robert", 
        "id": "sg:person.01112035026.17", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01112035026.17"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Conner", 
        "givenName": "Dale P.", 
        "id": "sg:person.01132227770.26", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01132227770.26"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Drug Evaluation and Research", 
          "id": "https://www.grid.ac/institutes/grid.483500.a", 
          "name": [
            "Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Li", 
        "givenName": "Bing V.", 
        "id": "sg:person.01365527214.96", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01365527214.96"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1208/s12248-013-9494-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040477921", 
          "https://doi.org/10.1208/s12248-013-9494-2"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00228-004-0763-y", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052071867", 
          "https://doi.org/10.1007/s00228-004-0763-y"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1023/a:1013643912335", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052899307", 
          "https://doi.org/10.1023/a:1013643912335"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1089/jam.2006.19.510", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1059278232"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2019-03", 
    "datePublishedReg": "2019-03-01", 
    "description": "In 2016, the US Food and Drug Administration (FDA) approved the first Abbreviated New Drug Application for Mometasone Furoate Nasal Suspension Spray. To establish the bioequivalence of this generic nasal suspension spray with the reference listed drug product (RLD), Nasonex\u00ae, a \"weight-of-evidence\" approach was utilized by the applicant that included formulation and device similarities, equivalent in vitro performance, equivalent systemic exposure, and equivalent local delivery. In addition to these testing for comprehensive evaluation of the drug product, FDA also considered supportive data generated by a novel in vitro method, Morphologically-Directed Raman Spectroscopy (MDRS), to characterize the particle size distribution (PSD) of active pharmaceutical ingredient (API) in the drug product. In this case, MDRS data eliminated the need for a comparative clinical endpoint bioequivalence study. The approval of the first generic Mometasone Furoate Nasal Suspension Spray is precedent-setting and paves a new pathway to establish bioequivalence for generic nasal suspension sprays. This approval also exemplifies FDA's commitment to advance regulatory science for evaluation of generic drug products.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1208/s12248-018-0283-9", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": false, 
    "isPartOf": [
      {
        "id": "sg:journal.1021863", 
        "issn": [
          "1234-1234", 
          "1550-7416"
        ], 
        "name": "The AAPS Journal", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "2", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "21"
      }
    ], 
    "name": "Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective", 
    "pagination": "14", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "3d7a31a0a12d9c7a7e9f3a98157e0935daaa8c2c9c96cc6a6813862d1dc5ae61"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "30617594"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "101223209"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1208/s12248-018-0283-9"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1111225255"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1208/s12248-018-0283-9", 
      "https://app.dimensions.ai/details/publication/pub.1111225255"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-11T10:58", 
    "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/v90/0000000352_0000000352/records_60333_00000003.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://link.springer.com/10.1208%2Fs12248-018-0283-9"
  }
]
 

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.10.1208/s12248-018-0283-9'

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

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1208/s12248-018-0283-9'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1208/s12248-018-0283-9'

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

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1208/s12248-018-0283-9'


 

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

139 TRIPLES      21 PREDICATES      33 URIs      21 LITERALS      9 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1208/s12248-018-0283-9 schema:about anzsrc-for:11
2 anzsrc-for:1115
3 schema:author N3bd1adbea6e642978ab0d3568c8e2a67
4 schema:citation sg:pub.10.1007/s00228-004-0763-y
5 sg:pub.10.1023/a:1013643912335
6 sg:pub.10.1208/s12248-013-9494-2
7 https://doi.org/10.1089/jam.2006.19.510
8 schema:datePublished 2019-03
9 schema:datePublishedReg 2019-03-01
10 schema:description In 2016, the US Food and Drug Administration (FDA) approved the first Abbreviated New Drug Application for Mometasone Furoate Nasal Suspension Spray. To establish the bioequivalence of this generic nasal suspension spray with the reference listed drug product (RLD), Nasonex®, a "weight-of-evidence" approach was utilized by the applicant that included formulation and device similarities, equivalent in vitro performance, equivalent systemic exposure, and equivalent local delivery. In addition to these testing for comprehensive evaluation of the drug product, FDA also considered supportive data generated by a novel in vitro method, Morphologically-Directed Raman Spectroscopy (MDRS), to characterize the particle size distribution (PSD) of active pharmaceutical ingredient (API) in the drug product. In this case, MDRS data eliminated the need for a comparative clinical endpoint bioequivalence study. The approval of the first generic Mometasone Furoate Nasal Suspension Spray is precedent-setting and paves a new pathway to establish bioequivalence for generic nasal suspension sprays. This approval also exemplifies FDA's commitment to advance regulatory science for evaluation of generic drug products.
11 schema:genre research_article
12 schema:inLanguage en
13 schema:isAccessibleForFree false
14 schema:isPartOf N436bbd62a0a045a486ee72910089dbe0
15 Ndd2ec33dff594a65a84fb66fc0ac65b7
16 sg:journal.1021863
17 schema:name Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective
18 schema:pagination 14
19 schema:productId N041155ce179543529a07ee5ec223df13
20 N23c94e6fba8e404883082269f2f10e33
21 N846a7290c7c04191965ccd42b86f187d
22 Ne6926f8c43f64b7ca27cf2c456adfbf0
23 Nfc523d3fdb5b4efbaa952679fd319d21
24 schema:sameAs https://app.dimensions.ai/details/publication/pub.1111225255
25 https://doi.org/10.1208/s12248-018-0283-9
26 schema:sdDatePublished 2019-04-11T10:58
27 schema:sdLicense https://scigraph.springernature.com/explorer/license/
28 schema:sdPublisher N8c90c426933a45e29d6aee08218d5bc6
29 schema:url https://link.springer.com/10.1208%2Fs12248-018-0283-9
30 sgo:license sg:explorer/license/
31 sgo:sdDataset articles
32 rdf:type schema:ScholarlyArticle
33 N041155ce179543529a07ee5ec223df13 schema:name doi
34 schema:value 10.1208/s12248-018-0283-9
35 rdf:type schema:PropertyValue
36 N22b19bbceabe450294b93d52eee5aeec rdf:first sg:person.0640344526.53
37 rdf:rest Ndf879aa7c6114554a0ea31ef57bfd2d6
38 N23c94e6fba8e404883082269f2f10e33 schema:name readcube_id
39 schema:value 3d7a31a0a12d9c7a7e9f3a98157e0935daaa8c2c9c96cc6a6813862d1dc5ae61
40 rdf:type schema:PropertyValue
41 N3bd1adbea6e642978ab0d3568c8e2a67 rdf:first sg:person.01026141541.20
42 rdf:rest Nedbde5e978e040998d0603abad348174
43 N436bbd62a0a045a486ee72910089dbe0 schema:volumeNumber 21
44 rdf:type schema:PublicationVolume
45 N62570b6fdebe42fda66427f193e9fb19 rdf:first sg:person.0742074506.93
46 rdf:rest Nd4089a3152b344e4ba4822e7ce3ed0e5
47 N72fe090c3cb040f4a67a385ab4feea38 rdf:first sg:person.01365527214.96
48 rdf:rest rdf:nil
49 N846a7290c7c04191965ccd42b86f187d schema:name nlm_unique_id
50 schema:value 101223209
51 rdf:type schema:PropertyValue
52 N8c90c426933a45e29d6aee08218d5bc6 schema:name Springer Nature - SN SciGraph project
53 rdf:type schema:Organization
54 Nd4089a3152b344e4ba4822e7ce3ed0e5 rdf:first sg:person.0671167607.21
55 rdf:rest N22b19bbceabe450294b93d52eee5aeec
56 Ndd2ec33dff594a65a84fb66fc0ac65b7 schema:issueNumber 2
57 rdf:type schema:PublicationIssue
58 Ndf879aa7c6114554a0ea31ef57bfd2d6 rdf:first sg:person.01112035026.17
59 rdf:rest Nf17a21769124495b89c72c8449323698
60 Ne6926f8c43f64b7ca27cf2c456adfbf0 schema:name dimensions_id
61 schema:value pub.1111225255
62 rdf:type schema:PropertyValue
63 Nedbde5e978e040998d0603abad348174 rdf:first sg:person.0616556757.03
64 rdf:rest N62570b6fdebe42fda66427f193e9fb19
65 Nf17a21769124495b89c72c8449323698 rdf:first sg:person.01132227770.26
66 rdf:rest N72fe090c3cb040f4a67a385ab4feea38
67 Nfc523d3fdb5b4efbaa952679fd319d21 schema:name pubmed_id
68 schema:value 30617594
69 rdf:type schema:PropertyValue
70 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
71 schema:name Medical and Health Sciences
72 rdf:type schema:DefinedTerm
73 anzsrc-for:1115 schema:inDefinedTermSet anzsrc-for:
74 schema:name Pharmacology and Pharmaceutical Sciences
75 rdf:type schema:DefinedTerm
76 sg:journal.1021863 schema:issn 1234-1234
77 1550-7416
78 schema:name The AAPS Journal
79 rdf:type schema:Periodical
80 sg:person.01026141541.20 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
81 schema:familyName Liu
82 schema:givenName Qing
83 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01026141541.20
84 rdf:type schema:Person
85 sg:person.01112035026.17 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
86 schema:familyName Lionberger
87 schema:givenName Robert
88 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01112035026.17
89 rdf:type schema:Person
90 sg:person.01132227770.26 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
91 schema:familyName Conner
92 schema:givenName Dale P.
93 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01132227770.26
94 rdf:type schema:Person
95 sg:person.01365527214.96 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
96 schema:familyName Li
97 schema:givenName Bing V.
98 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01365527214.96
99 rdf:type schema:Person
100 sg:person.0616556757.03 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
101 schema:familyName Absar
102 schema:givenName Mohammad
103 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0616556757.03
104 rdf:type schema:Person
105 sg:person.0640344526.53 schema:affiliation https://www.grid.ac/institutes/grid.418152.b
106 schema:familyName Chowdhury
107 schema:givenName Badrul
108 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0640344526.53
109 rdf:type schema:Person
110 sg:person.0671167607.21 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
111 schema:familyName Guo
112 schema:givenName Changning
113 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0671167607.21
114 rdf:type schema:Person
115 sg:person.0742074506.93 schema:affiliation https://www.grid.ac/institutes/grid.483500.a
116 schema:familyName Saluja
117 schema:givenName Bhawana
118 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0742074506.93
119 rdf:type schema:Person
120 sg:pub.10.1007/s00228-004-0763-y schema:sameAs https://app.dimensions.ai/details/publication/pub.1052071867
121 https://doi.org/10.1007/s00228-004-0763-y
122 rdf:type schema:CreativeWork
123 sg:pub.10.1023/a:1013643912335 schema:sameAs https://app.dimensions.ai/details/publication/pub.1052899307
124 https://doi.org/10.1023/a:1013643912335
125 rdf:type schema:CreativeWork
126 sg:pub.10.1208/s12248-013-9494-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040477921
127 https://doi.org/10.1208/s12248-013-9494-2
128 rdf:type schema:CreativeWork
129 https://doi.org/10.1089/jam.2006.19.510 schema:sameAs https://app.dimensions.ai/details/publication/pub.1059278232
130 rdf:type schema:CreativeWork
131 https://www.grid.ac/institutes/grid.418152.b schema:alternateName AstraZeneca (United States)
132 schema:name Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
133 Respiratory, Inflammation and Autoimmunity, Medimmune, AstraZeneca Pharmaceuticals, Gaithersburg, Maryland, USA
134 rdf:type schema:Organization
135 https://www.grid.ac/institutes/grid.483500.a schema:alternateName Center for Drug Evaluation and Research
136 schema:name Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
137 Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
138 Office of Translational Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
139 rdf:type schema:Organization
 




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


...