| 000 | 00000nam 2200000zi 4500 |
| 001 | 9.945784 |
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| 003 | CaOODSP |
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| 005 | 20250113145659 |
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| 006 | m o d f |
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| 007 | cr cn |||||||| |
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| 008 | 241129e202412 onc ob f000 0 eng d |
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| 020 | |a9780660747330 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-266/2024E-PDF |
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| 245 | 00|aQuality (chemistry and manufacturing) guidance : |bnew drug submissions and abbreviated new drug submissions. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cDecember 2024. |
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| 264 | 4|c©2024 |
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| 300 | |a1 online resource (v, 67 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 | |aIssued also in French under title: Ligne directrice sur la qualité (chimie et fabrication) : présentations de drogue nouvelle et présentations abrégées de drogue nouvelle. |
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| 500 | |a"Date adopted 2017-10-30. Revised date 2024-12-18. Effective date 2024-12-18." |
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| 500 | |a"Pub.: 240665." |
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| 504 | |aIncludes bibliographical references. |
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| 650 | 0|aDrug approval|zCanada. |
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| 650 | 0|aPharmaceutical policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLigne directrice sur la qualité (chimie et fabrication) : |w(CaOODSP)9.945785 |
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| 795 | |tGuidance document : |w(CaOODSP)9.867966 |
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| 856 | 40|qPDF|s781 KB|uhttps://publications.gc.ca/collections/collection_2025/sc-hc/H164-266-2024-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/chemical-entity-products-quality/guidance-document-quality-chemistry-manufacturing-guidance-new-drug-submissions-ndss-abbreviated-new-drug-submissions.html |
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