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| 02811nam 2200421zi 4500 |
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| 001 | 9.863526 |
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| 003 | CaOODSP |
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| 005 | 20221107161312 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 181019t20182018onc #ob f000 0 eng d |
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| 020 | |a9780660282299 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH13-9/29-2018E-PDF |
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| 245 | 00|aGuidance document : |bdata requirements for safety and effectiveness of subsequent entry inhaled corticosteroid products used for the treatment of asthma. |
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| 246 | 10|aData requirements for safety and effectiveness of subsequent entry inhaled corticosteroid products used for the treatment of asthma |
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| 246 | 17|aData requirements for safety and effectiveness of subsequent entry ICS for asthma |
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| 264 | 1|aOttawa, ON : |bHealth Canada, |c2018. |
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| 264 | 4|c©2018 |
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| 300 | |a1 online resource (14 pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aTitle from cover. |
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| 500 | |a"Date Adopted: 2018/10/16 ; Effective Date: 2018/11/01." |
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| 500 | |aIssued also in HTML format. |
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| 500 | |aIssued also in French under title: Ligne directrice : exigences relatives à l'innocuité et l'efficacité pour des corticostéroides inhalés de commercialisation subséquente utilisés dans le traitement de l'asthme. |
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| 504 | |aIncludes bibliographical references. |
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| 520 | |a"This guidance is intended to assist sponsors in the collection and analysis of comparative clinical data for Inhaled Corticosteroid (ICS) products used for the treatment of asthma that contain the same medicinal ingredient and have the same conditions of use as the Canadian Reference Product (CRP) in order to meet the safety and effectiveness requirements under C.08 of the Food and Drug Regulations [Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3)]. The data and standards outlined in this guidance are intended to be applied to a new ICS product being compared to a product for which clinical safety and effectiveness data exist. For clarity, these types of products will be referred to as “subsequent entry ICS products” in this document"--Introduction, page 5. |
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| 692 | 07|2gccst|aHealth care products |
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| 692 | 07|2gccst|aSafety standards |
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| 692 | 07|2gccst|aComparison |
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| 710 | 1 |aCanada. |bHealth Canada. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.863527 |
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| 856 | 40|qPDF|s260 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-29-2018-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/inhaled-corticosteroid-profile/inhaled-corticosteroid-guidance.html |
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