Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Active as of 2024-11-01 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 267500</b></p><a name="267500"> </a><a name="hc267500"> </a><a name="267500-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 1; Last updated: 2024-08-05 19:57:34+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-journal-article-citation.html">JournalArticleCitation</a></p></div><p><b>url</b>: <a href="Citation-267500.html">Citation 26502880 A novel nasal powder formulation of glucagon: toxicology studies in animal models.</a></p><p><b>identifier</b>: FEvIR Object Identifier/267500, <code>https://pubmed.ncbi.nlm.nih.gov</code>/26502880, <a href="http://terminology.hl7.org/6.0.2/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid:
Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.
This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.1</p><p><b>version</b>: 2.0.0-ballot</p><p><b>title</b>: 26502880 A novel nasal powder formulation of glucagon: toxicology studies in animal models.</p><p><b>status</b>: Active</p><p><b>date</b>: 2024-11-01 10:20:00+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: </p><div><p>This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
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</div></td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td><div><p><strong>BACKGROUND:</strong> Glucagon nasal powder (GNP), a novel intranasal formulation of glucagon being developed to treat insulin-induced severe hypoglycemia, contains synthetic glucagon (10% w/w), beta-cyclodextrin, and dodecylphosphocholine. The safety of this formulation was evaluated in four studies in animal models.
<strong>METHODS:</strong> The first study evaluated 28-day sub-chronic toxicology in rats treated intranasally with 1 and 2 mg of GNP/day (0.1 and 0.2 mg glucagon/rat/day). The second study evaluated 28-day sub-chronic toxicology in dogs administered 20 and 40 mg of formulation/dog/day (2 and 4 mg glucagon/dog/day) intranasally. A pulmonary insufflation study assessed acute toxicology following intra-tracheal administration of 0.5 mg of GNP (0.05 mg glucagon) to rats. Local tolerance to 30 mg of GNP (equivalent to 3 mg glucagon, the final dose for humans) was tested through direct administration into the eyes of rabbits.
<strong>RESULTS:</strong> There were no test article-related adverse effects on body weight and/or food consumption, ophthalmology, electrocardiography, hematology, coagulation parameters, clinical chemistry, urinalysis, or organ weights, and no macroscopic findings at necropsy in any study. In rats, direct intra-tracheal insufflation at a dose of 0.5 mg of GNP/rat (0.05 mg glucagon/rat) did not result in adverse clinical, macroscopic, or microscopic effects. In dogs, the only adverse findings following sub-chronic use were transient (<30 s) salivation and sneezing immediately post-treatment and mild to moderate reversible histological changes to the nasal mucosa. Daily dosing over 28 days in rats resulted in mild to moderate, unilateral or bilateral erosion/ulceration of the olfactory epithelium, frequently with minimal to mild, acute to sub-acute inflammation of the lamina propria at the dorsal turbinates of the nasal cavity in 2/10 males and 3/10 females in the high-dose group (0.2 mg glucagon/day). These lesions resolved completely over 14 days. Histological examination of tissues from both sub-chronic studies in dogs and rats revealed no microscopic findings. In rabbits, clinical observations noted in the GNP-treated eye and/or surrounding areas included ≥1 of the following: clear discharge, red conjunctiva, partial closure, and swelling of the peri-orbital area, which correlated with erythema and edema noted during ocular observations and grading.
<AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">The studies reported here revealed no safety concerns associated with GNP in animal models. Studies published earlier have highlighted the local safety profile of intranasally administered cyclodextrins (a component of GNP). The choline group, the phosphate group, and the saturated 12-carbon aliphatic chain that are present in the dodecylphosphocholine excipient used in GNP are all present in the phospholipids and lecithins seen ubiquitously in mammalian cell membranes and are unlikely to pose safety concerns; this notion is supported by several studies conducted by the authors that revealed no safety concerns. Taken together, these results suggest that intranasal delivery of GNP holds promise as a future rescue medication for use by caregivers to treat insulin-induced hypoglycemic episodes in patients with type 1 or type 2 diabetes.
<strong>CONCLUSION:</strong> This novel drug product is well tolerated in animal models.</p>
</div></td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II Diabetes. Diabetologia. 2002;45:937–48. doi: 10.1007/s00125-002-0822-9.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/12136392/">https://pubmed.ncbi.nlm.nih.gov/12136392/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/12136392</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>Deary IJ. Symptoms of hypoglycaemia and effects on mental performance and emotions. In: Frier BM, Fisher M, editors. Hypoglycaemia in clinical diabetes. 2. Chicester, West Sussex, England: John Wiley & Sons Limited; 2007. pp. 25–48.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care. 2003;26:1902–12. doi: 10.2337/diacare.26.6.1902.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/12766131/">https://pubmed.ncbi.nlm.nih.gov/12766131/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/12766131</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Leckie AM, Graham MK, Grant JB, Ritchie PJ, Frier BM. Frequency, severity, and morbidity of hypoglycemia occurring in the workplace in people with insulin-treated diabetes. Diabetes Care. 2005;28:1333–8. doi: 10.2337/diacare.28.6.1333.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/15920048/">https://pubmed.ncbi.nlm.nih.gov/15920048/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/15920048</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005;28:2948–61. doi: 10.2337/diacare.28.12.2948.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/16306561/">https://pubmed.ncbi.nlm.nih.gov/16306561/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/16306561</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>UK Hypoglycemia Study Group Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia. 2007;50:1140–7. doi: 10.1007/s00125-007-0599-y.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/17415551/">https://pubmed.ncbi.nlm.nih.gov/17415551/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/17415551</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>Cryer PE. Hypoglycemia in diabetes: pathophysiology, prevalence, and prevention. Alexandria, VA: American Diabetes Association; 2009. The clinical problem of hypoglycemia in diabetes; pp. 1–15.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>American Diabetes Association Standards of medical care in diabetes—2015. Diabetes Care. 2015;38(suppl 1):S1–94.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/15618112/">https://pubmed.ncbi.nlm.nih.gov/15618112/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/15618112</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>Jain MK. Introduction to biological membranes. New York: John Wiley & Sons; 1988. Components of biological membranes; pp. 10–50.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>GLUCACON (glucagon for injection, rDNA origin) Product Monograph. Toronto, Ontario: Eli Lilly Canada Inc.; 2012 http://www.lilly.ca/en/pdf/product-monograph/04_rglucagon-pm_9july2012.pdf. Accessed 26 September 2015.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>GLUCAGEN® and GLUCAGEN® Hypokit 1 mg (glucagon) Product Monograph. Mississauga, Ontario: Novo Nordisk Canada Inc.; 2014. http://www.paladin-labs.com/our_products/PM_GlucaGen_EN.pdf. Accessed 26 September 2015.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Root MA, Ellis J, Staub A. Effect of glucagon on insulin hypoglycemia. Proc Soc Exp Biol Med. 1954;85:507–11. doi: 10.3181/00379727-85-20934.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/13167121/">https://pubmed.ncbi.nlm.nih.gov/13167121/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/13167121</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Eistrup C, Hjortkjaer RK, Pickersgill N, Virgo DM, Woolley AP. Glucagon produced by recombinant DNA technology: repeated dose toxicity studies, intravenous administration to CD rats and beagle dogs for four weeks. Pharmacol Toxicol. 1993;73:103–8. doi: 10.1111/j.1600-0773.1993.tb01544.x.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/8248004/">https://pubmed.ncbi.nlm.nih.gov/8248004/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/8248004</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Merkus FW, Verhoef JC, Marttin E, Romeijn SG, van der Kuy PH, Hermens WA, et al. Cyclodextrins in nasal drug delivery. Adv Drug Deliv Rev. 1999;36:41–57. doi: 10.1016/S0169-409X(98)00054-4.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/10837708/">https://pubmed.ncbi.nlm.nih.gov/10837708/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/10837708</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Asai K, Morishita M, Katsuta H, Hosoda S, Shinomiya K, Noro M, et al. The effects of water-soluble cyclodextrins on the histological integrity of the rat nasal mucosa. Int J Pharm. 2002;246:25–35. doi: 10.1016/S0378-5173(02)00345-9.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/12270606/">https://pubmed.ncbi.nlm.nih.gov/12270606/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/12270606</p></blockquote><blockquote><p><b>publicationForm</b></p><blockquote><p><b>publishedIn</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/published-in-type D020492}">Periodical</span></p><p><b>identifier</b>: Electronic ISSN Type/2050-6511, ISOAbbreviation/BMC Pharmacol Toxicol, ISSN Linking/2050-6511, Medline Title Abbreviation/BMC Pharmacol Toxicol, NLM Unique ID/101590449</p><p><b>title</b>: BMC pharmacology & toxicology</p><p><b>publisherLocation</b>: England</p></blockquote><p><b>citedMedium</b>: <span title="Codes:{http://hl7.org/fhir/cited-medium internet}">Internet</span></p><p><b>volume</b>: 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href="https://doi.org/10.1186/s40360-015-0026-9">https://doi.org/10.1186/s40360-015-0026-9</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type publishing-model}">Publishing Model</span></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier Electronic}">Electronic</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type chemical}">Chemical</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D011208}">Powders</span>, <span title="Codes:{https://meshb.nlm.nih.gov/ D047392}">beta-Cyclodextrins</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances 107-73-3}, {https://meshb.nlm.nih.gov/ D010767}">Phosphorylcholine</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances 53949-18-1}, {https://meshb.nlm.nih.gov/ C028810}">dodecylphosphocholine</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances 9007-92-5}, {https://meshb.nlm.nih.gov/ D005934}">Glucagon</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances JV039JZZ3A}, {https://meshb.nlm.nih.gov/ C031215}">betadex</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">MeSH heading</span></p><p><b>artifactAssessment</b>: <a href="#hc267500/meshHeading0">ArtifactAssessment: artifact[x] = this resource</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type publication-type}">Publication type</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D016428}">Journal Article</span>, <span title="Codes:{https://meshb.nlm.nih.gov/ D013485}">Research Support, Non-U.S. Gov't</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type knowledge-artifact-type}">Knowledge Artifact Type</span></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>artifactAssessment</b>: Classifier added by Computable Publishing LLC</p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type citation-subset}">Citation subset</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#citationsubset IM}">IM</span></p></blockquote><blockquote><p><b>contributorship</b></p><p><b>complete</b>: true</p><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc267500/contributor0">Reno FE</a></p><p><b>forenameInitials</b>: FE</p><p><b>affiliation</b>: , 130 Macaw Lane, Merritt Island, FL, 32952, USA. freno1@cfl.rr.com.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc267500/contributor1">Normand P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: ITR Laboratories Canada Inc. (ITR), 19601 Clark Graham Blvd, Baie d'Urfe, Quebec, Canada. pnormand@itrlab.com.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc267500/contributor2">McInally K</a></p><p><b>forenameInitials</b>: K</p><p><b>affiliation</b>: ITR Laboratories Canada Inc. (ITR), 19601 Clark Graham Blvd, Baie d'Urfe, Quebec, Canada. kmcinally@itrlab.com.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc267500/contributor3">Silo S</a></p><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: CiToxLAB North America, 445 Armand-Frappier Blvd, Laval, Québec, Canada. silos@ca.citoxlab.com.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc267500/contributor4">Stotland P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. patricia.stotland@locemia.com.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc267500/contributor5">Triest M</a></p><p><b>forenameInitials</b>: M</p><p><b>affiliation</b>: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. myriam.triest@locemia.com.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc267500/contributor6">Carballo D</a></p><p><b>forenameInitials</b>: D</p><p><b>affiliation</b>: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. dolores.carballo@locemia.com.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc267500/contributor7">Piché C</a></p><p><b>forenameInitials</b>: C</p><p><b>affiliation</b>: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. claude.piche@locemia.com.</p></blockquote></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor0</b></p><a name="267500/contributor0"> </a><a name="hc267500/contributor0"> </a><a name="267500/contributor0-en-US"> </a><p><b>name</b>: Frederick E Reno </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor1</b></p><a name="267500/contributor1"> </a><a name="hc267500/contributor1"> </a><a name="267500/contributor1-en-US"> </a><p><b>name</b>: Patrick Normand </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor2</b></p><a name="267500/contributor2"> </a><a name="hc267500/contributor2"> </a><a name="267500/contributor2-en-US"> </a><p><b>name</b>: Kevin McInally </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor3</b></p><a name="267500/contributor3"> </a><a name="hc267500/contributor3"> </a><a name="267500/contributor3-en-US"> </a><p><b>name</b>: Sherwin Silo </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor4</b></p><a name="267500/contributor4"> </a><a name="hc267500/contributor4"> </a><a name="267500/contributor4-en-US"> </a><p><b>name</b>: Patricia Stotland </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor5</b></p><a name="267500/contributor5"> </a><a name="hc267500/contributor5"> </a><a name="267500/contributor5-en-US"> </a><p><b>name</b>: Myriam Triest </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor6</b></p><a name="267500/contributor6"> </a><a name="hc267500/contributor6"> </a><a name="267500/contributor6-en-US"> </a><p><b>name</b>: Dolores Carballo </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor7</b></p><a name="267500/contributor7"> </a><a name="hc267500/contributor7"> </a><a name="267500/contributor7-en-US"> </a><p><b>name</b>: Claude Piché </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: ArtifactAssessment #meshHeading0</b></p><a name="267500/meshHeading0"> </a><a name="hc267500/meshHeading0"> </a><a name="267500/meshHeading0-en-US"> </a><p><b>artifact</b>: <a href="#hc267500">Citation 26502880 A novel nasal powder formulation of glucagon: toxicology studies in animal models.</a></p><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D000281}">Administration, Intranasal</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D000818}">Animals</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D019540}">Area Under Curve</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D001835}">Body Weight</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000187}">drug effects</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49487}">No</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D004285}">Dogs</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D005260}">Female</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D005934}">Glucagon</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000008}">administration & dosage</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49487}">No</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000493}">pharmacokinetics</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49487}">No</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000633}">toxicity</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49488}">Yes</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D006801}">Humans</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D008168}">Lung</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000187}">drug effects</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49487}">No</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000473}">pathology</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">is Major topic</span></td><td><span title="Codes:{https://ncithesaurus.nci.nih.gov/ncitbrowser C49487}">No</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D008297}">Male</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D008657}">Metabolic Clearance Rate</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D023421}">Models, Animal</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ D009929}">Organ Size</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ Q000187}">drug effects</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td><span 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<text
value="**BACKGROUND:** Glucagon nasal powder (GNP), a novel intranasal formulation of glucagon being developed to treat insulin-induced severe hypoglycemia, contains synthetic glucagon (10% w/w), beta-cyclodextrin, and dodecylphosphocholine. The safety of this formulation was evaluated in four studies in animal models.
**METHODS:** The first study evaluated 28-day sub-chronic toxicology in rats treated intranasally with 1 and 2 mg of GNP/day (0.1 and 0.2 mg glucagon/rat/day). The second study evaluated 28-day sub-chronic toxicology in dogs administered 20 and 40 mg of formulation/dog/day (2 and 4 mg glucagon/dog/day) intranasally. A pulmonary insufflation study assessed acute toxicology following intra-tracheal administration of 0.5 mg of GNP (0.05 mg glucagon) to rats. Local tolerance to 30 mg of GNP (equivalent to 3 mg glucagon, the final dose for humans) was tested through direct administration into the eyes of rabbits.
**RESULTS:** There were no test article-related adverse effects on body weight and/or food consumption, ophthalmology, electrocardiography, hematology, coagulation parameters, clinical chemistry, urinalysis, or organ weights, and no macroscopic findings at necropsy in any study. In rats, direct intra-tracheal insufflation at a dose of 0.5 mg of GNP/rat (0.05 mg glucagon/rat) did not result in adverse clinical, macroscopic, or microscopic effects. In dogs, the only adverse findings following sub-chronic use were transient (&lt;30 s) salivation and sneezing immediately post-treatment and mild to moderate reversible histological changes to the nasal mucosa. Daily dosing over 28 days in rats resulted in mild to moderate, unilateral or bilateral erosion/ulceration of the olfactory epithelium, frequently with minimal to mild, acute to sub-acute inflammation of the lamina propria at the dorsal turbinates of the nasal cavity in 2/10 males and 3/10 females in the high-dose group (0.2 mg glucagon/day). These lesions resolved completely over 14 days. Histological examination of tissues from both sub-chronic studies in dogs and rats revealed no microscopic findings. In rabbits, clinical observations noted in the GNP-treated eye and/or surrounding areas included ≥1 of the following: clear discharge, red conjunctiva, partial closure, and swelling of the peri-orbital area, which correlated with erythema and edema noted during ocular observations and grading.
<AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">The studies reported here revealed no safety concerns associated with GNP in animal models. Studies published earlier have highlighted the local safety profile of intranasally administered cyclodextrins (a component of GNP). The choline group, the phosphate group, and the saturated 12-carbon aliphatic chain that are present in the dodecylphosphocholine excipient used in GNP are all present in the phospholipids and lecithins seen ubiquitously in mammalian cell membranes and are unlikely to pose safety concerns; this notion is supported by several studies conducted by the authors that revealed no safety concerns. Taken together, these results suggest that intranasal delivery of GNP holds promise as a future rescue medication for use by caregivers to treat insulin-induced hypoglycemic episodes in patients with type 1 or type 2 diabetes.
**CONCLUSION:** This novel drug product is well tolerated in animal models."/>
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-01
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