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Academia and industry: lessons from the unfortunate events in Toronto.

https://arctichealth.org/en/permalink/ahliterature201078
Source
Lancet. 1999 Mar 6;353(9155):771-2
Publication Type
Article
Date
Mar-6-1999
Author
D G Nathan
D J Weatherall
Author Affiliation
Dana Farber Institute of Cancer Research, Boston, MA, USA.
Source
Lancet. 1999 Mar 6;353(9155):771-2
Date
Mar-6-1999
Language
English
Publication Type
Article
Keywords
Academic Medical Centers - legislation & jurisprudence - trends
Clinical Trials as Topic - legislation & jurisprudence
Drug Industry - legislation & jurisprudence - trends
Humans
Iron Chelating Agents - therapeutic use
Ontario
Pyridones - therapeutic use
Thalassemia - drug therapy
Notes
Comment In: Lancet. 1999 May 29;353(9167):188810359449
PubMed ID
10459956 View in PubMed
Less detail

[Adventures of a clinician in the jungle of bureaucracy. What every researcher should know before starting a clinical study?].

https://arctichealth.org/en/permalink/ahliterature176519
Source
Duodecim. 2004;120(23):2815-21
Publication Type
Article
Date
2004
Author
Anna Pelkonen
Mika Mäkelä
Tari Haahtela
Author Affiliation
HYKS:n iho- ja allergiasairaala, HUS. anna.pelkonen@hus.fi
Source
Duodecim. 2004;120(23):2815-21
Date
2004
Language
Finnish
Publication Type
Article
Keywords
Clinical Trials as Topic - legislation & jurisprudence
Finland
Humans
Licensure
Organizational Innovation
Politics
PubMed ID
15663250 View in PubMed
Less detail

An ethical and criminal law framework for research involving children in Canada.

https://arctichealth.org/en/permalink/ahliterature221907
Source
Health Law J. 1993;1:39-64
Publication Type
Article
Date
1993

Antiarrhythmic drug approval--the Health Protection Branch perspective.

https://arctichealth.org/en/permalink/ahliterature227094
Source
Can J Cardiol. 1991 Jan-Feb;7(1):47-8; discussion 49-50
Publication Type
Article
Author
M. Znamirowska
Author Affiliation
Cardiovascular Division, Bureau of Human Prescription Drugs, Ottawa, Ontario.
Source
Can J Cardiol. 1991 Jan-Feb;7(1):47-8; discussion 49-50
Language
English
Publication Type
Article
Keywords
Anti-Arrhythmia Agents
Canada
Clinical Trials as Topic - legislation & jurisprudence - standards
Drug Evaluation - standards
Drugs, Investigational
Government Agencies
Humans
PubMed ID
2025793 View in PubMed
Less detail

[Attitude of patient associations to clinical trials of new drugs].

https://arctichealth.org/en/permalink/ahliterature185277
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1688-90
Publication Type
Article
Date
Apr-14-2003
Author
Hanne Wendel Tybkjaer
Lene Witte
Mette Bruun Johannessen
Author Affiliation
Gigtforeningen, Gentoftegade 118, DK-2820 Gentofte.
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1688-90
Date
Apr-14-2003
Language
Danish
Publication Type
Article
Keywords
Antirheumatic Agents - adverse effects - therapeutic use
Attitude to Health
Clinical Trials as Topic - legislation & jurisprudence - standards
Cystic Fibrosis - drug therapy
Denmark
Drug Monitoring - standards
Drugs, Investigational - adverse effects - therapeutic use
Humans
Organizations
Patient Education as Topic - legislation & jurisprudence - standards
Patient Rights - legislation & jurisprudence
Patients - legislation & jurisprudence - psychology
Practice Guidelines as Topic - standards
Research Subjects - legislation & jurisprudence - psychology
Rheumatic Diseases - drug therapy
Abstract
Both the Danish Rheumatism Association and the Danish Cystic Fibrosis Association think that patients have a right of access to new and better medicine. The patients affiliated to these two patient groups are more than willing to enroll in clinical trials on new drugs. The Danish Rheumatism Association focuses on good information and security while the Danish Cystic Fibrosis Association has an unrestricted willingness to enroll in clinical trials.
PubMed ID
12756833 View in PubMed
Less detail
Source
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S3-10
Publication Type
Article
Date
Mar-2007
Author
L. Kelly
M. Lazzaro
C. Petersen
Author Affiliation
CNSD, BCANS, Therapeutic Products Directorate, Tunney's Pasture, Ottawa, ON, Canada.
Source
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S3-10
Date
Mar-2007
Language
English
Publication Type
Article
Keywords
Canada
Clinical Trials as Topic - legislation & jurisprudence - standards
Dementia - drug therapy
Drug Approval - legislation & jurisprudence - organization & administration
Drug Evaluation - legislation & jurisprudence - trends
Drug Industry - economics - legislation & jurisprudence - trends
Drug-Related Side Effects and Adverse Reactions
Humans
Meta-Analysis as Topic
Risk assessment
Abstract
The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues.
PubMed ID
17469674 View in PubMed
Less detail

Debate among researchers over mammography screening and the potential effect of that debate on screening in the United States.

https://arctichealth.org/en/permalink/ahliterature159433
Source
J Natl Cancer Inst. 2008 Jan 16;100(2):156
Publication Type
Article
Date
Jan-16-2008

41 records – page 1 of 5.