Abstract：
:Biotechnology represents an opportunity for innovative products, new markets, or capital investments, depending on one's perspective. A primary consideration in regulating this industry is to ensure that innovation is not stifled yet the public is protected from potentially unsafe or ineffective products. We compared the regulatory requirements and procedures for obtaining marketing approval for biotechnology products in the European Community (EC) and the United States and identified key concerns of the biotechnology industry regarding the regulatory aspects of these products. The methodology consisted of a secondary literature review and mail survey. Biotechnology products are approved faster in the EC than the US. Both the EC and the US use advisory or expert committees in their respective approval procedures, although the EC does so more regularly. Market exclusivity provisions for biotechnology products range from 6 to 10 years in the EC compared with 7 years for "orphan" biotechnology products in the US. Regulatory affairs managers of the biotechnology industry were most concerned about application review time periods, communication with regulatory agencies, consistency in implementing regulations, and public policy changes. These concerns provide insight into the deficiencies that exist in regulatory processes and are valuable in identifying problems and implementing improvements.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Hakim Z,Kucukarslan Ssubject
Has Abstractpub_date
1993-03-01 00:00:00pages
442-58; discussion 432issue
2eissn
0149-2918issn
1879-114Xjournal_volume
15pub_type
杂志文章,评审abstract：BACKGROUND:Since the recognition that asthma is characterized by extensive inflammation of the airways, the use of inhaled corticosteroids (ICSs) as controller therapy has become central to successful disease management. As the prevalence of asthma increases worldwide, there is concern about increasing numbers of patie...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/s0149-2918(03)80302-8
更新日期：2003-01-01 00:00:00
abstract：:This study sought to compare the efficacy and safety of glyburide and glipizide in elderly patients with well-controlled non-insulin-dependent diabetes mellitus (NIDDM). One hundred forty-five patients aged > or = 65 years with NIDDM that was controlled for at least 3 months with oral sulfonylurea therapy were enrolle...
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：
更新日期：1993-11-01 00:00:00
abstract：PURPOSE:Selumetinib (AZD6244, ARRY-142886), an oral, potent, and highly selective mitogen-activated protein kinase 1/2 inhibitor with a short half-life, has shown activity across various tumor types. Before initiation of Phase III trials, the site, scale, and color (hypromellose shell from white [Phase II] to blue [Pha...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2017.08.022
更新日期：2017-11-01 00:00:00
abstract：BACKGROUND:On February 3, 2006, the US Food and Drug Administration (FDA) approved a live, oral, pentavalent (G1-G4, P1[8]) human-bovine reassortant rotavirus vaccine for the prevention of rotavirus gastroenteritis (RVGE) in infants in the United States. The Advisory Committee of Immunization Practices of the Centers f...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2007.12.018
更新日期：2007-12-01 00:00:00
abstract：:Two groups of patients with idiopathic Parkinson's disease underwent quantified electroencephalography (EEGq) using fast Fourier transfer to assess the effects of treatment with citicholine. Evidence of cortical cognitive impairment was seen in one group but not in the other. Certain parameters were established which ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1992-09-01 00:00:00
abstract：OBJECTIVE:This study was undertaken to examine the dose-response relationship of zafirlukast (5 to 40 mg BID) and to assess the efficacy and tolerability of the 10-mg BID dose in school-aged children with mild to moderate asthma. BACKGROUND:The efficacy and tolerability of zafirlukast, an oral leukotriene-receptor ant...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究
doi：10.1016/S0149-2918(00)90007-9
更新日期：2000-06-01 00:00:00
abstract：OBJECTIVE:The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a BID injection regimen ...
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(04)90055-0
更新日期：2004-04-01 00:00:00
abstract：BACKGROUND:Partial seizure disorder is typically treated by monotherapy with antiepileptic drugs (AEDs). However, when the condition is refractory to the initial treatment regimen, patients may be switched to monotherapy with another AED or to combination therapy with the initial AED plus a second AED. OBJECTIVES:The ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2005.10.020
更新日期：2005-10-01 00:00:00
abstract：BACKGROUND:The Lescol Intervention Prevention Study (LIPS) was a multinational randomized controlled trial that showed a 47% reduction in the relative risk of cardiac death and a 22% reduction in major adverse cardiac events (MACEs) from the routine use of fluvastatin, compared with controls, in patients undergoing per...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2005.09.012
更新日期：2005-09-01 00:00:00
abstract：BACKGROUND:Prophylaxis with granulocyte colony-stimulating factor reduces the risk for febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy. OBJECTIVE:We estimated the incremental cost-effectiveness of primary prophylaxis (starting in cycle 1 of chemotherapy) with pegfilgrastim versus filgrasti...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2009.05.003
更新日期：2009-05-01 00:00:00
abstract：:The aim of this study was to evaluate the short-term and long-term effects of felodipine, a new dihydropiridine calcium antagonist, on arterial blood pressure (BP), the renin-angiotensin-aldosterone system, diuresis, natriuresis, and the atrial natriuretic factor (ANF). In 15 essential hypertensives (WHO class II) BP,...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1988-01-01 00:00:00
abstract：:The US population is multiethnic in composition: many languages thrive, and Spanish is the second most frequently spoken language. The Hispanic population is one of the fastest growing ethnic groups in the United States. The majority of Hispanics speak Spanish at home (63%), and a significant proportion speak little o...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/0149-2918(95)80054-9
更新日期：1995-07-01 00:00:00
abstract：:Allylestrenol was used to treat 375 women with threatened pregnancies. Results show that this drug is capable of maintaining pregnancy in a large series of ambulant patients and is safe for both mother and child. Allylestrenol does not maintain pregnancy if placental dysfunction is present, however. Newborns whose mot...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1980-01-01 00:00:00
abstract：:The objective of this study was to compare the cost of intravenous adenosine and intravenous dipyridamole in positron emission tomography (PET) in patients with coronary artery disease. A retrospective, open-label, case-control, cost-effectiveness analysis was performed in the out-patient nuclear medicine department o...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/s0149-2918(97)80141-5
更新日期：1997-05-01 00:00:00
abstract：:This prospective, clinical economic study was done to determine the cost impact of oral compared with intravenous (i.v.) ganciclovir for the maintenance treatment of newly diagnosed cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Efficacy and safety data were extracted from ...
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(96)80036-1
更新日期：1996-05-01 00:00:00
abstract：BACKGROUND:Few effective treatment methods are available for subacute sclerosing panencephalitis (SSPE),an infection associated with the measles virus. Interferons have shown some benefit in previous studies and clinical practice. OBJECTIVE:The purpose of this study was to compare the efficacy of 2 different regimens ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2004.11.002
更新日期：2004-11-01 00:00:00
abstract：BACKGROUND:Concomitant aspirin use is a risk factor for nonsteroidal anti-inflammatory drug (NSAID)-associated upper gastrointestinal toxicity. In high-risk individuals, such as those with a history of NSAID-related gastric ulcer bleeding, gastroprotective therapy with a proton pump inhibitor has been reported to reduc...
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/j.clinthera.2004.10.002
更新日期：2004-10-01 00:00:00
abstract：PURPOSE:Nemonoxacin is a novel C-8-methoxy nonfluorinated quinolone that has been approved for the treatment of community-acquired pneumonia (CAP) in adults. The goals of this study were to evaluate the pharmacokinetic (PK) and population PK parameters of nemonoxacin and to provide the appropriate dose adjustment recom...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/j.clinthera.2019.01.015
更新日期：2019-03-01 00:00:00
abstract：BACKGROUND:Many patients with asthma require an inhaled long-acting beta(2)-agonist (LABA) in addition to an inhaled corticosteroid to adequately control their disease. OBJECTIVE:The purpose of this study was to assess the long-term tolerability of a salmeterol xinafoate/ fluticasone propionate (SFC) hydrofluoroalkane...
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.2007.07.021
更新日期：2007-07-01 00:00:00
abstract：BACKGROUND:Varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, has been developed specifically for smoking cessation. In Japan, 39.3% of men smoke and this is a major public health concern. OBJECTIVE:The primary objective of this study was to evaluate the efficacy and dose-response r...
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.2007.06.012
更新日期：2007-06-01 00:00:00
abstract：BACKGROUND:In the treatment of chronic obstructive pulmonary disease (COPD), tiotropium bromide has a longer duration of action than ipratropium bromide; however, tiotropium bromide is a more expensive alternative treatment. At issue is whether tiotropium reduces the risk for hospital readmissions for COPD compared wit...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2012.10.007
更新日期：2013-04-01 00:00:00
abstract：:A single-blind comparison was undertaken to evaluate 250 mg of cinoxacin and 100 mg of nitrofurantoin, both drugs being given four times a day, for the treatment of urinary tract infections. Complete data are available from 58 patients, most of whom were treated for 10 to 15 days. The clinical response was similar in ...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：BACKGROUND:Desvenlafaxine succinate, a serotonin-norepinephrine reuptake inhibitor (SNRI), was approved by the US Food and Drug Administration (FDA) in February 2008 for the treatment of adult patients with major depressive disorder (MDD). Desvenlafaxine is the third SNRI approved by the FDA for this indication. OBJEC...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2009.07.012
更新日期：2009-06-01 00:00:00
abstract：:The added hypotensive effect of bevantolol, a new cardioselective beta-blocker, was studied in 244 patients with mild to moderate essential hypertension following prior treatment with hydrochlorothiazide or placebo. After four weeks of monotherapy with 50 mg/day or 100 mg/day of hydrochlorothiazide or placebo, the mea...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1985-01-01 00:00:00
abstract：BACKGROUND:Previous evaluations of the Southwestern Ontario (SSWO) cohort have reported that hypertension (HTN) and dyslipidemia (DYS) are undertreated illnesses; however, concomitant treatment is unknown. OBJECTIVES:The objectives of this study were to assess the prevalence and associated treatment of HTN and DYS in ...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究
doi：10.1016/j.clinthera.2008.06.004
更新日期：2008-06-01 00:00:00
abstract：PURPOSE:Improvement in health behaviors following cancer diagnosis may contribute to better prognosis and well-being. This study examines the prevalence of health behaviors in cervical cancer survivors who have completed treatment, and associations between health behaviors and quality of life (QOL). METHODS:We recruit...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2016.02.006
更新日期：2016-03-01 00:00:00
abstract：BACKGROUND:Prostaglandin analogues are effective ocular hypotensive agents and are being used increasingly in the treatment of elevated intraocular pressure (IOP). These agents are typically dosed once daily. OBJECTIVES:A pilot study was conducted to evaluate the duration of travoprost's IOP-lowering efficacy up to 84...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0149-2918(04)90008-2
更新日期：2004-01-01 00:00:00
abstract：BACKGROUND:Dipeptidyl peptidase-IV (DPP-IV) inhibitors represent a new class of oral antihyperglycemic agents. Sitagliptin is an orally active and selective DPP-IV inhibitor currently in Phase III development for the treatment of type 2 diabetes mellitus. OBJECTIVE:The aim of this study was to assess the pharmacokinet...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2006.01.015
更新日期：2006-01-01 00:00:00
abstract：:A total of 128 corticosteroid-independent adults with chronic allergic asthma were treated for six weeks with 400 micrograms/day of beclomethasone dipropionate aerosol. Most patients (114 or 89%) had a good to excellent response, characterized by a marked improvement in the signs and symptoms of asthma. Substantial im...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：:The United States maternal mortality rate has been rising for many years putting the US out of step with peer countries. There are many complex reasons for the rise in maternal deaths and recent data has demonstrated that there is a disproportionate risk for women of color. This article provides an overview of current...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2020.01.015
更新日期：2020-03-01 00:00:00
