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Assessing prescription medications for priority regulatory review.

https://arctichealth.org/en/permalink/ahliterature174776
Source
Regul Toxicol Pharmacol. 2005 Jun;42(1):70-6
Publication Type
Article
Date
Jun-2005
Author
Nigel S B Rawson
Author Affiliation
Center for Health Care Policy and Evaluation, Eden Prairie, MN, USA. nigel.s.rawson@gsk.com
Source
Regul Toxicol Pharmacol. 2005 Jun;42(1):70-6
Date
Jun-2005
Language
English
Publication Type
Article
Keywords
Canada
Drug Approval - legislation & jurisprudence - methods
Drug Evaluation - legislation & jurisprudence - methods - standards
Drug Prescriptions - standards
Humans
Pharmaceutical Preparations - classification - standards
Time Factors
United States
Abstract
Poor concordance exists between medications that receive a priority review in Canada and those given an expeditious review in the United States. The objectives of this study were to obtain an evaluation of the clinical significance of new drugs approved in both countries from expert clinical pharmacologists, and to examine the concordance of their aggregate assessment with whether or not the product received an expeditious review in either country. Five experts assessed 146 new medications approved in both Canada and the United States between 1996 and early 2002. Overall, the concordance between the experts' assessments was poor and there was large variation in products considered to be of sufficient importance for priority status. Nevertheless, the experts' evaluations suggested that several priority-reviewed products did not warrant such a review. Regulatory agencies select new medications of potential clinical significance to receive shorter review times to minimize the delay in access to them, but, in Canada, only a low proportion of priority-status products had review times within Health Canada's performance target. The large variation in the assessment of clinical significance suggests that a more appropriate strategy in Canada is to devote sufficient resources to reviewing all medications in a timely manner.
PubMed ID
15896445 View in PubMed
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Balancing early access with uncertainties in evidence for drugs authorized by prospective case series - systematic review of reimbursement decisions.

https://arctichealth.org/en/permalink/ahliterature301360
Source
Br J Clin Pharmacol. 2018 06; 84(6):1146-1155
Publication Type
Journal Article
Research Support, Non-U.S. Gov't
Systematic Review
Date
06-2018
Author
Susanna M Wallerstedt
Martin Henriksson
Author Affiliation
Department of Pharmacology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Source
Br J Clin Pharmacol. 2018 06; 84(6):1146-1155
Date
06-2018
Language
English
Publication Type
Journal Article
Research Support, Non-U.S. Gov't
Systematic Review
Keywords
Adolescent
Adult
Aged
Aged, 80 and over
Cost-Benefit Analysis
Decision Support Techniques
Drug Approval - legislation & jurisprudence - methods
Drug Costs - legislation & jurisprudence
Endpoint Determination
Evidence-Based Medicine - legislation & jurisprudence - methods
Female
Health Policy
Humans
Insurance, Health, Reimbursement - economics - legislation & jurisprudence
Male
Middle Aged
Models, Economic
Policy Making
Prospective Studies
Research Design - legislation & jurisprudence
Sweden
Treatment Outcome
Uncertainty
United Kingdom
Value-Based Health Insurance - economics
Young Adult
Abstract
To review clinical and cost-effectiveness evidence underlying reimbursement decisions relating to drugs whose authorization mainly is based on evidence from prospective case series.
A systematic review of all new drugs evaluated in 2011-2016 within a health care profession-driven resource prioritization process, with a market approval based on prospective case series, and a reimbursement decision by the Swedish Dental and Pharmaceutical Benefits Agency (TLV). Public assessment reports from the European Medicines Agency, published pivotal studies, and TLV, Scottish Medicines Consortium and National Institute of Health and Care Excellence decisions and guidance documents were reviewed.
Six drug cases were assessed (brentuximab vedotin, bosutinib, ponatinib, idelalisib, vismodegib, ceritinib). The validity of the pivotal studies was hampered by the use of surrogate primary outcomes and the absence of recruitment information. To quantify drug treatment effect sizes, the reimbursement agencies primarily used data from another source in indirect comparisons. TLV granted reimbursement in five cases, compared with five in five cases for Scottish Medicines Consortium and four in five cases for National Institute of Health and Care Excellence. Decision modifiers, contributing to granted reimbursement despite hugely uncertain cost-effectiveness ratios, were, for example, small population size, occasionally linked to budget impact, severity of disease, end of life and improved life expectancy.
For drugs whose authorization is based on prospective case series, most applications for reimbursement within public health care are granted. The underlying evidence has limitations over and above the design per se, and decision modifiers are frequently referred to in the value-based pricing decision making.
PubMed ID
29381234 View in PubMed
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[Demonstration of quality, safety and efficacy of biological products subject to changes in their manufacturing process].

https://arctichealth.org/en/permalink/ahliterature117720
Source
Antibiot Khimioter. 2013;58(9-10):45-55
Publication Type
Article
Date
2013
Author
A N Vasil'ev
E V Gavrishina
R R Niiazov
A A Snegireva
V K Adonin
Source
Antibiot Khimioter. 2013;58(9-10):45-55
Date
2013
Language
Russian
Publication Type
Article
Keywords
Drug Approval - legislation & jurisprudence - methods - organization & administration
Drug Contamination - prevention & control
Drug Industry - legislation & jurisprudence - methods - organization & administration - standards
Humans
Pharmaceutical Preparations
Quality Control
Russia
Abstract
Ensuring quality, safety and efficacy of the medicinal products placed on the market of the Russian Federation constitutes the area that requires strict regulation. When changes are made to the manufacturing process, the manufacturer generally needs to evaluate the relevant quality attributes of the product to demonstrate that modifications did not occur that would adversely impact the safety and efficacy of the drug. Where there is the lack of a sound legal basis, there is a need in harmonization of current Russian legislation with international and European rules governing medicinal product for human use to ensure quality, safety and efficacy thereof.
PubMed ID
24738243 View in PubMed
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The need for additional metrics to assess therapeutic equivalence of some multiphasic modified-release products.

https://arctichealth.org/en/permalink/ahliterature132075
Source
Clin Ther. 2011 Sep;33(9):1214-9
Publication Type
Article
Date
Sep-2011
Author
Peter M Kondra
Laszlo Endrenyi
Laszlo Tothfalusi
Author Affiliation
Department of Psychiatry & Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada. kondra@hhsc.ca
Source
Clin Ther. 2011 Sep;33(9):1214-9
Date
Sep-2011
Language
English
Publication Type
Article
Keywords
Advisory Committees
Area Under Curve
Canada
Delayed-Action Preparations - pharmacokinetics
Drug Approval - legislation & jurisprudence - methods
Drugs, Generic - pharmacokinetics
Government Regulation
Humans
Therapeutic Equivalency
United States
United States Food and Drug Administration
Abstract
Advisory committees for the regulatory agencies of the United States (US Food and Drug Administration [FDA]) and Canada (Health Canada) recently considered issues associated with the determination of bioequivalence for some multiphasic modified-release (MR) drug products. The FDA has concluded that because of the complicated properties of some multiphasic MR products, additional metrics such as partial AUC are required for their assessment, whereas an advisory panel of Health Canada has decided that the current metrics are adequate and sufficient.
The authors agree with the conclusion of the FDA that additional metrics are required.
The rationales considered by the advisory committees are discussed and commented upon. It is suggested that without applying an additional metric such as partial AUC, some multiphasic MR drug products might falsely be assumed to be therapeutically equivalent and unexpected clinical effects may occur.
PubMed ID
21849209 View in PubMed
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Outcomes for assessment of symptomatic and stabilization/disease modifying drugs.

https://arctichealth.org/en/permalink/ahliterature163865
Source
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S23-6
Publication Type
Article
Date
Mar-2007
Author
Serge Gauthier
Author Affiliation
Alzheimer Disease Research Unit, McGill Centre for Studies in Aging, Verdun, Quebec, Canada.
Source
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S23-6
Date
Mar-2007
Language
English
Publication Type
Article
Keywords
Biological Markers - analysis
Canada
Clinical Trials as Topic - methods - standards
Disease Progression
Drug Approval - legislation & jurisprudence - methods
Drug-Related Side Effects and Adverse Reactions
Humans
Outcome and Process Assessment (Health Care) - standards - trends
Predictive value of tests
Reproducibility of Results
Treatment Outcome
Abstract
The safety and efficacy of current symptomatic drugs for AD was established using parallel groups taking different doses of active drugs vs placebo over three to twelve months, whereas drugs with potential stabilizing/disease modifying effects are being tested by adding new compounds or placebo to standard symptomatic drugs over 12 to 18 months. Delaying progression to disease milestones may offer additional validity to these studies. It is unclear if biological and neuroimaging markers will add to the clinical evidence.
PubMed ID
17469677 View in PubMed
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[The inspection by the Danish Medical Products Agency of drug clinical trials].

https://arctichealth.org/en/permalink/ahliterature185285
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1656-8
Publication Type
Article
Date
Apr-14-2003
Author
Erik Jacobsen
Irene Stilbo
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1656-8
Date
Apr-14-2003
Language
Danish
Publication Type
Article
Keywords
Adverse Drug Reaction Reporting Systems - legislation & jurisprudence
Clinical Trials as Topic - legislation & jurisprudence - standards
Denmark
Drug Approval - legislation & jurisprudence - methods - organization & administration
Drug Monitoring - methods - standards
Drug and Narcotic Control - legislation & jurisprudence
Government Agencies
Guidelines as Topic
Humans
Informed Consent - legislation & jurisprudence
Research Subjects - legislation & jurisprudence
Abstract
An official review by the regulatory authorities of the conduct of a clinical trial is called a GCP-inspection and is an important element of Good Clinical Practice. The Danish Medicines Agency initiated GCP-inspections in Denmark in 1992. The article gives a short description of the inspections together with a few examples of findings during the inspections.
PubMed ID
12756822 View in PubMed
Less detail

[The role of the Danish Medical Products Agency in clinical trials].

https://arctichealth.org/en/permalink/ahliterature185286
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1653-6
Publication Type
Article
Date
Apr-14-2003
Author
Anne Catrine Simonsen
Author Affiliation
Laegemiddelstyrelsen, Sektion for Kliniske Forsøg, Inspektionen. acsi@dadlnet.dk
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1653-6
Date
Apr-14-2003
Language
Danish
Publication Type
Article
Keywords
Adverse Drug Reaction Reporting Systems - legislation & jurisprudence
Clinical Trials as Topic - legislation & jurisprudence
Denmark
Drug Approval - legislation & jurisprudence - methods - organization & administration
Drug Monitoring
Drug and Narcotic Control - legislation & jurisprudence
Drugs, Investigational
European Union
Government Agencies
Guidelines as Topic
Humans
Patient Rights - legislation & jurisprudence
Physician's Role
Practice Guidelines as Topic
Abstract
The registration and legislation concerning clinical trials are described with specific focus on subjects of importance to Danish doctors. Especially the investigators' responsibility for the registration of the trial, reporting of serious adverse events and final report to the agency are mentioned. The fact that the evaluation of a protocol will focus on the risk, the contents of essential new knowledge and the design are emphasised. The process of approval and the fees are mentioned, and finally the changes caused by the new GCP-directive are discussed.
PubMed ID
12756821 View in PubMed
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8 records – page 1 of 1.