|
000
| 02005nam 2200373za 4500 |
|---|
| 001 | 9.852787 |
|---|
| 003 | CaOODSP |
|---|
| 005 | 20230313122855 |
|---|
| 007 | cr ||||||||||| |
|---|
| 008 | 180302s2018 oncd o f000 0 eng d |
|---|
| 020 | |a9780660255125 |
|---|
| 040 | |aCaOODSP|beng |
|---|
| 043 | |an-cn--- |
|---|
| 086 | 1 |aH13-9/6-2018E-PDF |
|---|
| 245 | 00|aGuidance document |h[electronic resource] : |bconduct and analysis of comparative bioavailability studies. |
|---|
| 246 | 30|aConduct and analysis of comparative bioavailability studies |
|---|
| 246 | 17|aConduct & analysis of comparative bioavailability studies |
|---|
| 260 | |aOttawa : |bHealth Canada, |c2018. |
|---|
| 300 | |a35 p. : |bcharts. |
|---|
| 500 | |aIssued also in French under title: Ligne directrice : conduite et analyse des études de biodisponibilité comparatives. |
|---|
| 500 | |aCover title. |
|---|
| 500 | |a"Date adopted: 2012/02/08. Revised date: 2018/06/08. Effective date: 2018/09/01 (for submissions filed on or September 1, 2018)." |
|---|
| 500 | |a"Publication date: June 2018." |
|---|
| 500 | |aIssued also in HTML format. |
|---|
| 520 | |a"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. |
|---|
| 693 | 4|aDrug approval |
|---|
| 693 | 4|aDrugs--Bioavailability |
|---|
| 693 | 4|aHandbooks |
|---|
| 710 | 1 |aCanada. |bHealth Canada. |
|---|
| 775 | 08|tLigne directrice |w(CaOODSP)9.852793 |
|---|
| 794 | |tGuidance document : |w(CaOODSP)9.919266 |
|---|
| 856 | 40|qPDF|s689 KB|uhttps://publications.gc.ca/collections/collection_2018/sc-hc/H13-9-6-2018-eng.pdf |
|---|
| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/conduct-analysis-comparative.html |
|---|