Abstract：
:Bioequivalence studies are mainly required to demonstrate the interchangeability of multisource pharmaceutical products, usually called generics. A pivotal investigation projected and conducted in compliance with specific guidelines allows a replicative company to register a generic drug via an ANDA (abbreviated new drug application) procedure. Serious problems are often encountered in planning and conducting these studies, which are not covered by operating guidelines, and call for protocols to be set up on a case-by-case basis. The main problems involve the high variability of some active ingredients, how to manage baseline with endogenous substances, drugs with a long terminal half-life, drugs under genetic polymorphic metabolism, drugs possessing stereogenic centre(s), and drugs which cannot ethically be given to healthy volunteers. These problems are extensively covered in this paper and, where appropriate, possible solutions are suggested.
journal_name
Pharmacol Resjournal_title
Pharmacological researchauthors
Marzo Adoi
10.1016/s1043-6618(05)80028-3subject
Has Abstractpub_date
1995-10-01 00:00:00pages
237-40issue
4eissn
1043-6618issn
1096-1186pii
S1043-6618(05)80028-3journal_volume
32pub_type
杂志文章abstract：:The vascular endothelial growth factor receptor-1 (VEGFR-1) is a membrane receptor for VEGF-A, placenta growth factor (PlGF) and VEGF-B that plays a crucial role in melanoma invasiveness, vasculogenic mimicry and tumor-associated angiogenesis. Furthermore, activation of VEGFR-1 is involved in the mobilization of myelo...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2020.104957
更新日期：2020-09-01 00:00:00
abstract：:Cocoa contains flavonoids with antioxidant properties. The aim of this study was to ascertain the effect of cocoa intake on oxidative stress associated with a model of chronic inflammation such as adjuvant arthritis. Female Wistar rats were fed with a 5% or 10% cocoa-enriched diet or were given p.o. a quercetin suspen...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2012.05.009
更新日期：2012-09-01 00:00:00
abstract：:Antifertility activity of a triterpenoid glycoside, DSS, isolated from the root of Dalbergia saxatilis was investigated in female Wistar rats of breeding age. When administered by gastric intubation at a dose rate of 200 mg kg(-1)body weight at the premating period, conception was inhibited in 71.4% of the treated ani...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1006/phrs.1999.0615
更新日期：2000-05-01 00:00:00
abstract：:Curcumin, a bioactive polyphenol, is a yellow pigment of the Curcuma longa (turmeric) plant. Curcumin has many pharmacologic effects including antioxidant, anti-carcinogenic, anti-obesity, anti-angiogenic and anti-inflammatory properties. Recently, it has been found that curcumin affects lipid metabolism, and subseque...
journal_title：Pharmacological research
pub_type： 杂志文章,评审
doi：10.1016/j.phrs.2017.02.008
更新日期：2017-05-01 00:00:00
abstract：:The metabolism of arachidonic acid by cytochrome P450 (CYP) epoxygenases generates epoxyeicosatrienoic acids (EETs) which affect numerous cellular process including Ca(2+) signaling and the activity of Ca(2+)-dependent K(+) channels. The expression of the CYP epoxygenase(s) that generate EETs in endothelial cells is n...
journal_title：Pharmacological research
pub_type： 杂志文章,评审
doi：10.1016/j.phrs.2003.11.016
更新日期：2004-06-01 00:00:00
abstract：:Prader-Willi syndrome (PWS), the leading genetic cause of obesity, is characterized by a striking hyperphagic behavior that can lead to obesity, type-2 diabetes, cardiovascular disease and death. The molecular mechanism underlying impaired satiety in PWS is unknown. Oleoylethanolamide (OEA) is a lipid mediator involve...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2016.12.024
更新日期：2017-03-01 00:00:00
abstract：:The interaction of mianserin with ethanol in central nervous system (CNS) was investigated. Mianserin was administered at a single dose of 5 or 20 mgkg(-1) i.p. or as daily injections in a dose of 2.5 mgkg(-1) given for 14 days. The influence of mianserin on acute ethanol toxicity (LD(50)), on ED(50) of ethanol in rot...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/s1043-6618(02)00031-2
更新日期：2002-07-01 00:00:00
abstract：:A new class of methylfuroxans and methylfurazans arylthio, arylsulphinyl and arylsulphonyl substituted, characterized by vasodilating and antiaggregatory properties, is described. Vasodilating activity, tested on rabbit aortic rings percontracted with 1 microM noradrenaline, is enhanced by N-oxidation of the furazan r...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1006/phrs.1993.1123
更新日期：1993-10-01 00:00:00
abstract：:In China, child and adolescent pediatricians often face challenges in treating children with the appropriate medications. Within the last 8 years, the Chinese government has already initiated a series of policies to promote development of age-appropriate medicines for children. In this study,we introduced the current ...
journal_title：Pharmacological research
pub_type： 杂志文章,评审
doi：10.1016/j.phrs.2019.104412
更新日期：2019-10-01 00:00:00
abstract：:The aim of this study was to investigate effect of antiemetics on G6PD and antioxidant enzymes. Antiemetics are currently being used to reduce or prevent nausea and vomiting in patients. This is the first study to show effect of antiemetics on glucose-6-phosphate dehydrogenase (G6PD) and antioxidant enzyme activities....
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2004.05.007
更新日期：2004-11-01 00:00:00
abstract：:One of the most serious side effects of the immunosuppressive agent, cyclosporin A (CsA), is drug-related hypertension. As it is generally accepted, the sympathetic nervous system may play an important role in the development or maintenance of this abnormal pathophysiological situation. This study is aimed at assessin...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1006/phrs.1999.0572
更新日期：2000-02-01 00:00:00
abstract：:Nephrotoxicity associated with cyclosporine A (CsA) administration is characterized by marked renal vasoconstriction, interstitial fibrosis and arteriolar hypertrophy. The molecular mechanisms of CsA nephrotoxicity are not well characterized, but previous studies have demonstrated that angiotensin II (Ang II), the pri...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1006/phrs.2002.0959
更新日期：2002-05-01 00:00:00
abstract：:In 1996, Dr. Costa was invited by Prof. Boris Astrachan, Chairman of the Department of Psychiatry at the University of Illinois at Chicago, to direct the research of the "Psychiatric Institute, Department of Psychiatry, School of Medicine, at the University of Illinois at Chicago." He was asked to develop a seminal re...
journal_title：Pharmacological research
pub_type： 历史文章,杂志文章,评审
doi：10.1016/j.phrs.2011.05.026
更新日期：2011-10-01 00:00:00
abstract：:Autism-spectrum disorder (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and repetitive patterns of behavior. ASD is, however, often associated with medical comorbidities and gastrointestinal (GI) dysfunction is among the most common. Studies have demonstrated a corr...
journal_title：Pharmacological research
pub_type： 杂志文章,评审
doi：10.1016/j.phrs.2018.03.020
更新日期：2018-06-01 00:00:00
abstract：:A substantial number of G-protein coupled receptors (GPCRs) genetic disorders are due to mutations that cause misfolding or dysfunction of the receptor product. Pharmacological chaperoning approaches can rescue such mutant receptors by stabilizing protein conformations that behave similar to the wild type protein. For...
journal_title：Pharmacological research
pub_type： 杂志文章,评审
doi：10.1016/j.phrs.2016.12.036
更新日期：2017-03-01 00:00:00
abstract：:Availability of highly active antiretroviral therapy has dramatically increased survival rates and substantially modified the course of HIV infection, which has now become a chronic disease both in adults and in children. Treatment strategies in paediatric patients have to face with specific challenges associated with...
journal_title：Pharmacological research
pub_type： 社论,评审
doi：10.1016/j.phrs.2011.01.007
更新日期：2011-07-01 00:00:00
abstract：:Contrasting results have been reported on the role of rs628031 and rs683369 polymorphisms of SLC22A1 and rs776746 of CYP3A5 on imatinib treatment response in patients with chronic myeloid leukemia (CML). In the present study, we conducted a systematic review and meta-analysis of published studies to estimate the impac...
journal_title：Pharmacological research
pub_type： 杂志文章,meta分析
doi：10.1016/j.phrs.2018.02.005
更新日期：2018-05-01 00:00:00
abstract：:Dyslipidemia and hyperglycemia are associated with an increased risk of ischemic cardiovascular disease. Positive effects of a nutraceutical combination comprising red yeast rice, berberine, policosanol, astaxanthin, coenzyme Q10 and folic acid (NComb) on plasma lipid and glucose levels have been reported in some but ...
journal_title：Pharmacological research
pub_type： 杂志文章,meta分析,评审
doi：10.1016/j.phrs.2016.04.021
更新日期：2016-08-01 00:00:00
abstract：:Gastrointestinal toxicity and red skin discoloration were the major side effects observed in leprosy patients undergoing long-term treatment with clofazimine (CFZ). Hematological and biochemical alterations have been cited among other side effects; however, their real magnitude and clinical significance at the doses c...
journal_title：Pharmacological research
pub_type： 临床试验,杂志文章
doi：10.1016/s1043-6618(02)00086-5
更新日期：2002-08-01 00:00:00
abstract：:Beneficial therapeutic effects of dihydropyridine derivatives in cardiovascular and neurological disorders are often associated with selective L-type Ca(2+)channel blockade. Here the new dihydropyridine derivatives Bay E5759 (1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid ethyl-1-methylethyl ...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1006/phrs.2001.0836
更新日期：2001-08-01 00:00:00
abstract：:The Notch pathway represents a highly conserved signaling network with essential roles in regulation of key cellular processes and functions, many of which are critical for development. Accumulating evidence indicates that it is also essential for fibrosis and thus the pathogenesis of chronic fibroproliferative diseas...
journal_title：Pharmacological research
pub_type： 杂志文章,评审
doi：10.1016/j.phrs.2016.04.010
更新日期：2016-06-01 00:00:00
abstract：:We have studied the effect of acute trazodone (3--20 mg kg(-1)) and quipazine (1--3 mg kg(-1)) treatment on the apomorphine-induced (1 mg kg(-1), once daily over 2 weeks) aggressive behaviour in male Wistar rats. All doses of trazodone and quipazine tested attenuated the aggressiveness as evidenced by the abolished in...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1006/phrs.2000.0790
更新日期：2001-04-01 00:00:00
abstract：CONTEXT:Ticagrelor was related to bradycardia in DISPERSE-II trial. This risk has been integrated into the European risk-management plan, and its use is warned in at-risk patients. Nevertheless, this risk was not systematically assessed nor measured. OBJECTIVES:To estimate the risk of bradyarrhythmia associated with t...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2020.105089
更新日期：2020-10-01 00:00:00
abstract：:The effects of trans-resveratrol (RSV) combined with ethanol (EtOH) were evaluated by (31)P NMR on total ATP and sn-glycerol-3-phosphate (sn-G3P) contents measured in real time in isolated and perfused whole liver of the rat. Mitochondrial ATP turnover was assessed by using specific inhibitors of glycolytic and mitoch...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2011.12.003
更新日期：2012-03-01 00:00:00
abstract：:It has been reported that patients with Hodgkin's disease (HD) show altered porphyrin metabolism, and suggested that the cause is the neoplastic process itself. If this is true, disease progression should be associated with higher levels of porphyrin excretion. The aim of this study was to evaluate urinary coproporphy...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2004.09.005
更新日期：2005-03-01 00:00:00
abstract：:Green tea (Camellia sinensis, Theaceace) is the second most popular beverage in the world and has been extensively studied for its putative disease preventive effects. Green tea is characterized by the presence of a high concentrations of polyphenolic compounds known as catechins, with (-)-epigallocatechin-3-gallate (...
journal_title：Pharmacological research
pub_type： 杂志文章,评审
doi：10.1016/j.phrs.2010.12.013
更新日期：2011-08-01 00:00:00
abstract：:Inflammation plays a key role in tumor promotion and development. Indeed, cyclooxygenase-2 (COX-2) expression is strongly associated with different types of cancer. An emerging class of compounds with significant anti-inflammatory properties is the hydrogen sulfide-releasing non-steroidal anti-inflammatory drugs (H2S-...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2016.10.019
更新日期：2016-12-01 00:00:00
abstract：:Anti-hypertensive agents may differently stimulate compensatory neuro-hormonal mechanisms and induce different effects on the cardiovascular remodeling and function. The combination of low doses of the two synergistic drugs may lead to a lesser activation of counter regulatory mechanisms and could provide optimal ther...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2004.10.010
更新日期：2005-04-01 00:00:00
abstract：:Vanillin is one of the most widely used flavor compounds in food and personal products. It has been reported that vanillin is able to inhibit mutagenesis induced by chemical and physical mutagens, and to suppress the invasion and migration of cancer cells. Herein we used the oligonucleotide microarray approach to stud...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2007.09.009
更新日期：2007-12-01 00:00:00
abstract：:The blood-brain barrier (BBB) keeps the central nervous system (CNS) safe from various brain diseases, while the BBB makes it difficult for effective drugs to enter the CNS. Mfsd2a is specifically expressed on the cell membrane of brain-microvascular endothelial cell (BMEC) and is implicated in the delivery of some su...
journal_title：Pharmacological research
pub_type： 杂志文章
doi：10.1016/j.phrs.2015.12.024
更新日期：2016-02-01 00:00:00
