Health Canada's Human Vaccine Lot Release Program: Impact on the 3Rs

Procedia in Vaccinology

Volumn 5, Issue , 2011, Pages 147-150

  Isbrucker, Richard ^a   Sontakke, Sushama ^a   Smith, Dean ^a  

^a HEALTH CANADA   (Canada)

Author keywords

Alternative methods; Health Canada; Human vaccines; Lot release

Indexed keywords

VACCINE;

ARTICLE; CANADA; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG MANUFACTURE; DRUG MARKETING; DRUG POTENCY; DRUG SAFETY; DRUG SCREENING; HUMAN; IN VITRO STUDY; LOT RELEASE PROGRAM; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL;

EID: 84555196684     PISSN: None     EISSN: 1877282X     Source Type: Journal    
DOI: 10.1016/j.provac.2011.10.012     Document Type: Article

References (3)

1. Health Canada. Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs. Ottawa, Ontario, Canada: Health Canada Publications, 2005 (effective 1 June 2005). Available at: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/lot/gui_sponsors-dir_promoteurs_lot_program-eng.php.
2. Calver GA. Implementation of the three Rs in regulatory testing of vaccines in Canada. Dev Biol (Basel) 2002;111:207-212.
3. Canada Council on Animal Care (CCAC) [Internet]. Ottawa, Ontario, Canada: CCAC, 2005-2010. Available from: www.ccac.ca.