Abstract：
BACKGROUND:The median time to approval of new drugs in Canada decreased considerably in the mid-1990s, although it continued to be longer than in such countries as Australia, Sweden, the United Kingdom, and the United States. Ongoing concern about approval times pointed to a need for a further international comparison. OBJECTIVE:This study was designed to assess whether there have been continuing improvements in drug approval times in Canada relative to these other countries. METHODS:Application and approval dates of new chemical or biological substances approved for marketing from 1999 through 2001 were requested from the Canadian, Australian, and Swedish regulatory agencies. Information for the United States was derived from publications of the Pharmaceutical Research and Manufacturers of America. The regulatory agency for the United Kingdom does not release application dates, although these were the same as the Swedish application dates for most drugs approved in both countries through the centralized European Union (EU) review procedure. Application dates for drugs licensed under the EU mutual-recognition arrangement or in the United Kingdom only were requested from the relevant pharmaceutical companies. RESULTS:One hundred eighty-six new drugs were approved in >/=1 of the countries studied between January 1999 and December 2001: 17 (9.1%) in all 5 countries, 25 (13.4%) in 4, 27 (14.5%) in 3, 39 (21.0%) in 2, and 78 (41.9%) in 1. Approval times were longer in Canada than in Australia, although not significantly so (median time, 645 and 551 days, respectively). Canadian and Australian approval times were significantly longer than those in Sweden (431 days), the United Kingdom (479 days), and the United States (371 days) (P < 0.001). The annual median approval time in Canada increased in each of the 3 years. The approval times of priority-reviewed drugs in Canada were significantly longer than in the United States (median 317 vs 232 days) but significantly shorter than in Australia (509 days) (both comparisons, P < 0.001). CONCLUSIONS:Overall approval times of new drugs in Canada were longer than those in Australia, Sweden, the United Kingdom, and the United States in the period studied. The findings warrant ongoing monitoring of Canadian drug approval times.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Rawson NSdoi
10.1016/s0149-2918(03)80080-2subject
Has Abstractpub_date
2003-04-01 00:00:00pages
1230-47issue
4eissn
0149-2918issn
1879-114Xpii
S0149291803800802journal_volume
25pub_type
杂志文章abstract：:Antihypertensive drugs are commonly prescribed for the treatment of patients with both diabetes and hypertension. However, the role of selected agents in the development of hypoglycemia remains controversial. The main objective of this study was to evaluate the effect of antihypertensive agents on the risk of hypoglyc...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(99)80039-3
更新日期：1999-08-01 00:00:00
abstract：:Coexisting diseases may have unforeseen yet clinically significant effects on patients' well-being. Both generic and disease-specific measures are frequently used to assess health-related quality of life (QOL). The present study assessed the effects of comorbidity on the results of QOL measures through an analysis of ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/S0149-2918(00)88295-8
更新日期：1999-02-01 00:00:00
abstract：PURPOSE:Intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are associated with several potential health benefits, but standard ethyl ester (EE) formulations of these ω-3 fatty acids require the co-ingestion of fat for adequate absorption. The objective of this research was to assess the relative bioa...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2018.10.014
更新日期：2018-12-01 00:00:00
abstract：PURPOSE:Interruptions in opioid use have the potential to cause pain relapse and withdrawal symptoms. The objectives of this study were to observe patterns of opioid interruption during acute illness in nursing home residents and examine associations between interruptions and pain and withdrawal symptoms. METHODS:Pati...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2014.10.013
更新日期：2014-11-01 00:00:00
abstract：OBJECTIVE:This study evaluated the efficacy and tolerability of glimepiride in patients with type 2 diabetes mellitus that was inadequately controlled with a combination of immediate- or extended-release metformin and a thiazolidinedione. METHODS:This was a multicenter, randomized, double-blind, placebo-controlled, pa...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.clinthera.2005.10.017
更新日期：2005-10-01 00:00:00
abstract：OBJECTIVE:This paper examines the rationale for using direct thrombin inhibitors in the management of acute coronary syndrome (ACS). BACKGROUND:With traditional management of ACS using aspirin and unfractionated heparin (UH), refractory angina and new myocardial infarction (MI) continue to develop. Growing understandi...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析
doi：10.1016/S0149-2918(00)80065-X
更新日期：2000-08-01 00:00:00
abstract：:The bacteriologic profile in 1081 pediatric patients with culture-positive symptomatic bacteriuria was studied over a 30-month period in a 500-bed acute care hospital in Riyadh, Saudi Arabia. Microbial isolates were considered significant if their numbers equaled or exceeded 10,000 colony-forming units/mL in symptomat...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(96)80010-5
更新日期：1996-03-01 00:00:00
abstract：:A benzothiazepine derivative, CRD-401, was administered orally in a dosage of 60 to 120 mg/day to 14 patients with various renal diseases. The systolic pressure was lowered slightly in some cases after administration of CRD-401. Urine volume and urinary excretion of electrolytes were increased by the drug in most pati...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1981-01-01 00:00:00
abstract：PURPOSE:In patients with type 2 diabetes mellitus, fixed-dose combinations (FDCs) of antihyperglycemic medications may provide complementary efficacy while reducing tablet burden and improving compliance. The aim of this study was to assess the bioequivalence and tolerability of 2 FDCs of dapagliflozin and metformin ex...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2015.11.010
更新日期：2016-01-01 00:00:00
abstract：PURPOSE:Opioid diversion, misuse, and abuse are rapidly growing problems in the United States; >60% of all drug overdose deaths involve an opioid. At least 49 states now have fully operational prescription drug monitoring programs (PDMPs) to support legitimate medical use of controlled substances; however, there is con...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.07.040
更新日期：2017-09-01 00:00:00
abstract：:A parallel-group, randomized, double-blind, forced-titration, multicenter study was done to compare the efficacy and safety of once-daily nifedipine coat-core (NIF CC) and once-daily nifedipine gastrointestinal therapeutic system (NIF GITS) dosed in the fasting state in patients with mild-to-moderate essential hyperte...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/0149-2918(95)80028-x
更新日期：1995-03-01 00:00:00
abstract：:The objective of this study was to assess a weight-based heparin (WBH) nomogram (80-U/kg bolus, 18-U/kg-per-hour initial infusion) and determine its clinical performance and impact on resource utilization. All patients treated with heparin for venous thromboembolism or unstable angina during a 15-week study period wer...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/s0149-2918(98)80133-1
更新日期：1998-07-01 00:00:00
abstract：:Calorie/protein malnutrition is a common problem among dialysis patients. A study was designed to determine the value of adding a mixture of amino acids to the diet of 36 patients (mean age, 42 years) who had been receiving triweekly hemodialysis for periods ranging from 1 to 13 years. For 1 month the patients receive...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1993-07-01 00:00:00
abstract：BACKGROUND:Changing etiologic patterns and the growing problem of antimicrobial resistance, particularly an increase in macrolide-resistant pneumococcal bacteremia, are causing physicians to adopt new approaches to the treatment of community-acquired pneumonia (CAP). OBJECTIVE:The relative efficacy and tolerability of...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/s0149-2918(02)80034-0
更新日期：2002-08-01 00:00:00
abstract：:Eleven patients suffering from WHO stage II essential arterial hypertension were treated with the combination of labetalol plus chlorthalidone in the reciprocal ratio of 10:1 in the form of once-a-day administration in the morning. The dosage was individualized on the basis of hypotensive response and side effects unt...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1981-01-01 00:00:00
abstract：PURPOSE:Saliva is a reliable, noninvasive, and cost-effective alternative to biomarkers measured in other biological fluids. Within certain populations, saliva sampling may be difficult because of insufficient saliva flow, which may compromise disease diagnosis or research integrity. Methods to improve flow rates (eg, ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2015.02.015
更新日期：2015-03-01 00:00:00
abstract：BACKGROUND:Seasonal allergic rhinitis (SAR) is an allergen-induced inflammatory reaction that occurs during periods of high pollen count. Current treatments for SAR include allergen avoidance, systemic antihistamines, and steroidal and nonsteroidal intranasal sprays. Olopatadine is a selective antihistamine and an inhi...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.clinthera.2009.01.016
更新日期：2009-01-01 00:00:00
abstract：BACKGROUND:The prevalence of gout has been increasing. Serum uric acid (sUA) levels ≥6 mg/dL have been associated with high morbidity and increased health care utilization. OBJECTIVE:To assess the costs and patterns of health care resource utilization for patients with gout, categorized into 3 cohorts based on sUA lev...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2012.01.020
更新日期：2012-03-01 00:00:00
abstract：BACKGROUND:Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality. Published practice guidelines and treatment algorithms for COPD are designed to increase awareness of the problem and improve patient care; however, <40% of subjects diagnosed with COPD are receiving appropri...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2007.10.006
更新日期：2007-10-01 00:00:00
abstract：BACKGROUND:Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulating protein, was the first biologic agent approved for, and the first drug approved in 55 years for, the treatment of systemic lupus erythematosus (SLE) by the US Food and Drug Administration (FDA). OBJECTIVE:This article reviews the curren...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2012.02.028
更新日期：2012-05-01 00:00:00
abstract：BACKGROUND:Diabetes mellitus (DM) is a powerful independent risk factor for multivessel, diffuse coronary artery disease (CAD). The optimal coronary revascularization strategy in DM is not clearly defined, but past trials have suggested an advantage for coronary artery bypass grafting (CABG). Recently, the Future Revas...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2013.07.427
更新日期：2013-08-01 00:00:00
abstract：OBJECTIVE:The goal of this multicenter, double-blind, randomized, parallel-group study was to compare the effects of losartan potassium (hereafter referred to as losartan), candesartan cilexitil (hereafter referred to as candesartan), and losartan/hydrochlorothiazide (HCTZ) in patients with mild to moderate hypertensio...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/s0149-2918(00)83062-3
更新日期：2000-10-01 00:00:00
abstract：PURPOSE:To evaluate the safety and efficacy of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with acute myocardial infarction (AMI) in the presence of intracoronary thrombus undergoing percutaneous coronary interventions. METHODS:This study, performed from January 1, 2004, to November 31, 2014, at 55 centers in ...
journal_title：Clinical therapeutics
pub_type： 信件,多中心研究
doi：10.1016/j.clinthera.2020.02.022
更新日期：2020-05-01 00:00:00
abstract：BACKGROUND:A sprinkle capsule formulation containing enteric-coated, delayed-release rabeprazole granules is being developed for the treatment of children with gastrointestinal reflux disease. The granules are designed to be mixed with vehicles that facilitate delivery to children, who may be unable to swallow solid fo...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2012.06.008
更新日期：2012-07-01 00:00:00
abstract：:The safety and efficacy of twice-daily applications of alclometasone dipropionate cream 0.05% were evaluated in 39 children with eczema during a three-week open study. Early-morning plasma cortisol levels were monitored at weekly intervals (visits 1, 2, and 3) for six children. For the remaining 33 children, levels we...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1986-01-01 00:00:00
abstract：BACKGROUND:Despite favorable evidence from clinical trials for single-dose palonosetron versus other commercially available 5-HT(3)-receptor antagonists for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV), clinical comparative data are scarce from hospital outpatient settings, where these antiemetic ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2011.04.009
更新日期：2011-04-01 00:00:00
abstract：BACKGROUND:Communicating potential benefits and harm to patients and payers is essential for high-quality care. However, there are no published guidelines or consensuses on how to communicate potential benefits and harm to patients and payers. OBJECTIVE:The goal of this review was to identify key elements for communic...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2011.11.013
更新日期：2011-12-01 00:00:00
abstract：:The long-term tolerability and efficacy of indomethacin were evaluated in a retrospective study of 67 patients with moderate to severe rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis who took the drug daily for periods ranging from three to 20 years. Only patients who had not experienced side effects d...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1986-01-01 00:00:00
abstract：:The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) may be the most significant piece of legislation affecting the practice of pharmacy since the Durham-Humphrey amendments to the Food, Drug and Cosmetic Act. As part of the OBRA-90 legislation, the Health Care Financing Administration (HCFA) was required to publis...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1993-05-01 00:00:00
abstract：:Fifty clinic patients with mild to moderately severe dermatoses were treated for three weeks with bufexamac, a hydroxamic acid compound with anti-inflammatory properties. Half the patients had either contact or seborrheic dermatitis; the remaining 25 were distributed among five other diagnostic categories. Evaluation ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1980-01-01 00:00:00
