Abstract：
:Against the backdrop of the COVID pandemic, the scientific and medical communities are working with all deliberate speed with state-of-the-art technologies to develop diagnostic and therapeutic products that can identify, treat, and prevent infection with SARS-CoV-2. These activities may only be legally conducted with the necessary statutes and regulations in place to facilitate the timely development, manufacturing, evaluation, and distribution of products that meet quality standards. The present regulatory landscape for medicinal and medical products for human use has been shaped by nearly 12 decades of statutory history that followed in reaction to disasters and tragedies. Five distinct, closely woven threads of statutory history have led to the regulatory infrastructure we have in place: (1) standardized processes for routine development of medicinal and medical device products for human use; (2) processes for expedited development to shorten time frames and expand patient populations; (3) mechanisms of Expanded Access to make medicinal products available to patients prior to approval of the US Food and Drug Administration; (4) Emergency Use Authorization during public health emergencies; and (5) the development of pathways for bringing generic drugs and biosimilar biologics to market. These mechanisms are being brought to bear to facilitate the defeat of infection with SARS-CoV-2.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Beninger Pdoi
10.1016/j.clinthera.2020.06.014subject
Has Abstractpub_date
2020-08-01 00:00:00pages
1444-1450issue
8eissn
0149-2918issn
1879-114Xpii
S0149-2918(20)30324-6journal_volume
42pub_type
杂志文章abstract：BACKGROUND:Patients' preferences for medications may be important in determining their compliance with therapy, particularly in the case of an asymptomatic chronic disease such as osteoporosis. Although preferences for certain attributes of osteoporosis medications, including dosing frequency and tolerability, can be e...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(07)80087-7
更新日期：2007-03-01 00:00:00
abstract：PURPOSE:The objective of this study was to assess the frequency of tablet splitting of psychotropic drugs in a population of older adults with a diagnosis of dementia. METHODS:This retrospective, cross-sectional study examined a sample of geriatric outpatients seen at a public center specializing in the care of elderl...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2015.08.015
更新日期：2015-10-01 00:00:00
abstract：BACKGROUND:Therapeutic proteins have revolutionized the treatment of many diseases. In the near future, many more therapeutic proteins are likely to become available for an increasingly wide range of indications. OBJECTIVES:This article reviews the incidence, causes, and consequences of formation of antibodies to ther...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/s0149-2918(02)80075-3
更新日期：2002-11-01 00:00:00
abstract：:A new technique to estimate water uptake by the gastrointestinal tract was tested in infants undergoing elective surgery. Patients were randomly allocated to receive either sterile water or a glucose-electrolyte solution labeled with the stable isotope H2O18. After absorption, the isotopic O18 comes to rapid equilibri...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1990-01-01 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：PURPOSE:Despite the rapid proliferation of hyaluronate (HA) and corticosteroid (CO) injections and clinical guidelines regarding their use in osteoarthritis (OA), information on the characteristics of people receiving these injections is scarce. We describe the use of injections among adults with radiographically confi...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.01.006
更新日期：2017-02-01 00:00:00
abstract：BACKGROUND:Physiologic changes of aging may affect processes of drug absorption and distribution, in some cases necessitating age-dependent dose adjustment. OBJECTIVE:The possibility of age dependence in the pharmacokinetic behavior and tolerability of levormeloxifene was investigated in a single-center, open-label st...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(01)80030-8
更新日期：2001-01-01 00:00:00
abstract：PURPOSE:The goal of this study was to assess the effect of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) on lipid profiles in patients with type 2 diabetes. METHODS:The MEDLINE, Embase, Cochrane Library, and ClinicalTrials.gov databases were searched from inception through October 31, 2013. Randomized controll...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析,评审
doi：10.1016/j.clinthera.2014.11.008
更新日期：2015-01-01 00:00:00
abstract：PURPOSE:The goal of this study was to assess and compare the potential clinical and economic value of emerging bone-forming agents using the only currently available agent, teriparatide, as a reference case in patients at high, near-term (imminent, 1- to 2-year) risk of osteoporotic fractures, extending to a lifetime h...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.05.348
更新日期：2017-07-01 00:00:00
abstract：BACKGROUND:Recombinant activated factor VII (rFVIIa) is indicated to treat bleeding episodes or prevent bleeding related to surgery in patients with hemophilia A or B who have antibodies to coagulation factors VIII or IX. The first-generation rFVIIa formulation is stable when stored under refrigeration. A new formulati...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(08)80055-0
更新日期：2008-07-01 00:00:00
abstract：:One hundred children with peritonitis resulting from a perforated appendix were treated with ceftazidime or netilmicin. Metronidazole was added to both groups to treat the anaerobic organisms commonly associated with the infecting aerobic organisms in peritonitis. Escherichia coli was the most common aerobe found in p...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1990-01-01 00:00:00
abstract：INTRODUCTION:Acute generalized exanthematous pustulosis (AGEP) is a clinical reaction pattern that is principally drug induced and is characterized by acute, extensive formation of nonfollicular sterile pustules on an erythematous and edematous substrate. Hydroxychloroquine (HHCQ), an antimalarial drug widely used to t...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2008.05.014
更新日期：2008-05-01 00:00:00
abstract：:Hyaluronic acid is the most abundant mucopolysaccharide in connective tissue. Because of its high viscous elasticity, it lubricates joints and can hold cells together in the intercellular spaces in connective tissue. The administration of exogenous hyaluronic acid can increase the repair potential of damaged tissue. A...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1989-11-01 00:00:00
abstract：BACKGROUND:During the past 5 years, there has been much concern about the safety of and ease of access to drugs that are unavailable without a prescription in the United States but are manufactured and can be purchased over the counter (OTC) in Mexico. However, based on a literature search, studies have not been perfor...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2005.05.007
更新日期：2005-05-01 00:00:00
abstract：PURPOSE:This study examined the utility of therapeutic drug monitoring (TDM) of imatinib, nilotinib, and dasatinib in adult patients with chronic-phase chronic myeloid leukemia (CML). TDM in CML entails the measurement of plasma tyrosine kinase inhibitor (TKI) concentration to predict efficacy and tolerability outcomes...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析
doi：10.1016/j.clinthera.2019.10.009
更新日期：2019-12-01 00:00:00
abstract：:Thirty children with serious gram-negative infections were treated with either netilmicin, 2 mg/kg, or tobramycin, 1 mg/kg, every eight hours for a minimum of 72 hours. Because of the administration of different doses, a "blind" investigator evaluated treatment response while another investigator adjusted the doses on...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1983-01-01 00:00:00
abstract：:Patients with Parkinson's disease experience disabling non-motor symptoms, including autonomic dysfunction, cognitive decline, and sleep disorders. Pharmacologic treatments for these symptoms are often ineffective or have intolerable side effects. Therefore, non-pharmacologic interventions are an attractive alternativ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.11.004
更新日期：2018-01-01 00:00:00
abstract：:Healing rates were examined retrospectively in 124 outpatients with peptic ulcer who had received cimetidine for at least four weeks. Treatment was unsuccessful in 73 patients. A statistical analysis of the factors involved in treatment failure revealed that in patients with duodenal ulcers 60.6% of the treatment succ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1984-01-01 00:00:00
abstract：OBJECTIVE:The objectives of this study were to observe a commercially insured sample diagnosed with a venous thromboembolism (VTE) event and treated postevent with warfarin and to detail the thromboembolic and bleeding outcomes in the time periods during warfarin therapy and after discontinuation of such therapy. METH...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(04)90187-7
更新日期：2004-07-01 00:00:00
abstract：:Cisapride is a substituted piperidinyl benzamide. It is chemically related to metoclopramide but lacks the antidopaminergic properties of metoclopramide that affect the central nervous system and cause extrapyramidal side effects. Cisapride is indicated for the symptomatic treatment of patients with nocturnal heartbur...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/s0149-2918(98)80092-1
更新日期：1998-03-01 00:00:00
abstract：:In a double-blind study, 59 patients with chronic erosive gastritis received 50 mg of pirenzepine twice daily and 55 patients received 400 mg of cimetidine twice daily for six weeks. In both groups, days of pain, of heartburn, and of nausea per week were significantly reduced during treatment (P less than 0.01). After...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1989-11-01 00:00:00
abstract：OBJECTIVES:The primary study objective was to assess the time course and intensity of sedation after administration of immediate-release (IR) and extended-release (XR) quetiapine fumarate in healthy subjects during dose initiation. The tolerability of the 2 formulations was also evaluated. METHODS:This was a randomize...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2009.03.002
更新日期：2009-03-01 00:00:00
abstract：BACKGROUND:Citalopram and theophylline may be prescribed together to treat patients with depression and asthmatic disease. Because theophylline has a low therapeutic index, small changes in plasma levels may result in therapeutic failure or adverse effects. Both citalopram and theophylline are metabolized by cytochrome...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/s0149-2918(00)83047-7
更新日期：2000-12-01 00:00:00
abstract：BACKGROUND:Cobalamin (vitamin B12) deficiency, the most common cause of megaloblastic anemia, is treated with intramuscular (IM) cobalamin. It has been suggested by some investigators that oral (p.o.) cobalamin treatment may be as effective in the treatment of this condition, with the advantages of ease of administrati...
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(03)90096-8
更新日期：2003-12-01 00:00:00
abstract：BACKGROUND:Combined therapy with cilostazol, an antiplatelet agent, and probucol, an antihyperlipidemic agent, has been reported to prevent restenosis after percutaneous transluminal coronary angioplasty. However, the potential for pharmacokinetic drug interactions between the 2 agents has not been evaluated. OBJECTIV...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2009.10.005
更新日期：2009-10-01 00:00:00
abstract：BACKGROUND:The use of dopamine agonists (DAs) for the treatment of restless legs syndrome (RLS) has been assessed in numerous randomized clinical trials (RCTs). OBJECTIVES:The aims of this study were to assess the reporting quality of published RCTs according to the Consolidated Standards of Reporting Trials (CONSORT)...
journal_title：Clinical therapeutics
pub_type： 杂志文章,meta分析,评审
doi：10.1016/j.clinthera.2010.01.028
更新日期：2010-02-01 00:00:00
abstract：:Twenty-five patients with typhoid fever, who were resistant to amoxicillin and chloramphenicol, were successfully treated with ofloxacin. Ofloxacin was administered at a dosage of 200 mg three times daily for 7 to 10 days. In a few seriously ill patients, a dosage of 400 mg three times daily for 3 days, followed by 20...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1994-09-01 00:00:00
abstract：:The pharmacodynamic parameter that appears to correlate best with a successful therapeutic outcome with beta-lactam antibiotics is the length of time the serum antibiotic concentration remains above the minimum inhibitory concentration (MIC) for the infecting pathogen. By maximizing this parameter, continuous administ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/S0149-2918(00)86736-3
更新日期：1999-11-01 00:00:00
abstract：BACKGROUND:The emergence of multidrug-resistant nosocomial pathogens, such as Pseudomonas aeruginosa and Acinetobacter baumannii, has led to the revival of the systemic use of antimicrobial agent colistin in critically ill patients, but only limited data are available to define its pharmacokinetic profile in these pati...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：10.1016/j.clinthera.2008.01.015
更新日期：2008-01-01 00:00:00
abstract：PURPOSE:Although the efficacy of canagliflozin has been well established in clinical trials, research regarding its use and impact on outcomes in clinical practice has been limited by the availability of data on observations up to and beyond 6 months after the initial use of canagliflozin. The purpose of this study was...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2016.07.009
更新日期：2016-09-01 00:00:00
