00000000nam 2200000zi 4500
0019.867966
003CaOODSP
00520241129150203
006m     o  d f      
007cr cn|||||||||
008190204t20172017onc     o    f000 0 eng d
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-266/2018E-PDF
24500|aGuidance document : |bquality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs).
24630|aQuality (chemistry and manufacturing) guidance : |bnew drug submissions (NDSs) and abbreviated new drug submissions (ANDSs)
264 1|a[Ottawa] : |bHealth Canada = Santé Canada, |c[2017]
264 4|c©2017.
300 |a1 online resource (vi, 85 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued also in French under title: Ligne directrice : qualité (chimie et fabrication) : présentations de drogue nouvelle (PDN) et présentations abrégées de drogue nouvelle (PADN).
500 |aCover title.
500 |a"Health Products and Food Branch."
500 |aIncludes addendum (questions and answers).
500 |aIssued also in HTML format.
69207|2gccst|aDrugs
69207|2gccst|aHealth policy
7101 |aCanada. |bHealth Canada.
7101 |aCanada. |bHealth Products and Food Branch.
77508|tLigne directrice : |w(CaOODSP)9.867968
794 |tQuality (chemistry and manufacturing) guidance : |w(CaOODSP)9.945784
85640|qPDF|s336 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H164-266-2018-eng.pdf|z(guidance document)
85640|qPDF|s58 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H164-266-2018-1-eng.pdf|z(addendum)
8564 |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|z(guidance document)