00000nam 22000008a 4500 9.852795 CaOODSP 20221107154654 cr ||||||||||| 180302s2018 onc ob f000 0 eng d 9780660255149 CaOODSP eng n-cn--- H13-9/7-2018E-PDF Guidance document [electronic resource] : comparative bioavailability standards : formulations used for system effects. Comparative bioavailability standards : formulations used for system effects Ottawa : Health Canada, 2018. 16 p. Issued also in French under title: Ligne directrice : normes en matière d’études de biodisponibilité comparatives : formes pharmaceutiques de médicaments à effets systémiques. Cover title. "Date adopted: 2012/12/08. Revised date: 2018/06/08. Effective date: 2018/07/01 (for submissions filed on or September 1, 2018)." "Publication date: June 2018." Issued also in HTML format. Includes bibliographical references (p. 14). "Policy objectives: To ensure that sponsors of new drug submissions have 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 with respect to comparative bioavailability and comparative pharmacodynamic studies used in support of the safety and efficacy of a drug"--Introd., p. 9. Drug approval Drugs--Bioavailability Drugs--Therapeutic equivalency Standards Canada. Health Canada. Ligne directrice (CaOODSP)9.852796 PDF 287 KB https://publications.gc.ca/collections/collection_2018/sc-hc/H13-9-7-2018-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/comparative-bioavailability-standards-formulations-used-systemic-effects.html 170501