00000nam 2200000za 4500 9.852787 CaOODSP 20230313122855 cr ||||||||||| 180302s2018 oncd o f000 0 eng d 9780660255125 CaOODSP eng n-cn--- H13-9/6-2018E-PDF Guidance document [electronic resource] : conduct and analysis of comparative bioavailability studies. Conduct and analysis of comparative bioavailability studies Conduct & analysis of comparative bioavailability studies Ottawa : Health Canada, 2018. 35 p. : charts. Issued also in French under title: Ligne directrice : conduite et analyse des études de biodisponibilité comparatives. Cover title. "Date adopted: 2012/02/08. Revised date: 2018/06/08. Effective date: 2018/09/01 (for submissions filed on or September 1, 2018)." "Publication date: June 2018." Issued also in HTML format. "Policy objectives: To provide sponsors of new drug submissions with the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations (Regulations) with respect to comparative bioavailability studies used in support of the safety and efficacy of a drug"--Introd., p. 9. Drug approval Drugs--Bioavailability Handbooks Canada. Health Canada. Ligne directrice (CaOODSP)9.852793 Guidance document : (CaOODSP)9.919266 PDF 689 KB https://publications.gc.ca/collections/collection_2018/sc-hc/H13-9-6-2018-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/conduct-analysis-comparative.html 170507