1 option
Subsequent entry biologic review report Inflectra (Infliximab) / Canadian Agency for Drugs and Technologies in Health.
- Format:
- Book
- Author/Creator:
- Canadian Agency for Drugs and Technologies in Health, author, issuing body.
- Language:
- English
- Subjects (All):
- Adulthood.
- Outcome assessment (Medical care).
- Physical Description:
- 1 online resource (vii, 77 pages) : illustrations
- Place of Publication:
- Canada : Canadian Agency for Drugs and Technologies in Health, 2017.
- Summary:
- The CADTH Common Drug Review (CDR) approach to reviewing Inflectra followed the CDR Procedure and Submission Guidelines for Subsequent Entry Biologics (March, 2014). The CDR team reviewed the information provided by the manufacturer regarding product information, indications under review, the manufacturer's requested listing criteria, biosimilarity, extrapolation, and cost. Clinical Study Reports and published articles were also appraised. Reviewers provided a critical appraisal of the clinical evidence, a discussion of extrapolation from the indications of rheumatoid arthritis (RA) and ankylosing spondylitis (AS) to inflammatory bowel disease (IBD), and an evaluation of cost.
- Notes:
- Description based on publisher supplied metadata and other sources.
The Penn Libraries is committed to describing library materials using current, accurate, and responsible language. If you discover outdated or inaccurate language, please fill out this feedback form to report it and suggest alternative language.