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Pan-Canadian Pharmaceutical Alliance (pCPA): Timelines Analysis and Policy Implications
(2019-02-18)
This analysis follows our recent study showing that Canadian public reimbursement delays have lengthened from regulatory approval to listing decisions by public drug plans and delayed public access to innovative medicines, ...
Appraisal of patient-reported outcome measures in analogous diseases and recommendations for use in phase II and III clinical trials of pyruvate kinase deficiency
(2018-11-19)
Purpose: Pyruvate kinase deficiency (PKD) is a rare disease and understanding of its epidemiology and associated burden remains limited. With no current curative therapy, clinical manifestations can be life threatening, ...
Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines
(2018-09-28)
Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations ...