Abstract:
INTRODUCTION:The Annual Meeting of the Safety Pharmacology (SP) Society is a yearly event designed to keep attendees abreast of how to best identify and mitigate organ function liabilities of candidate drugs selected for clinical assessment. AREAS COVERED:Heart rate (HR) and blood pressure (BP) effects of candidate drugs in dogs/monkeys have satisfactory human translation. Mechanism-designed assays offer opportunities for innovative approaches to identify chemotherapeutic-induced peripheral neuropathy (PN). SP has a large array of methodologies to determine safety on eye functions. Video-tracking analysis of zebrafish swimming behavior accurately profiles drugs for high-level brain function liabilities. Available in vitro and in vivo assays can identify, and determine physiological and pharmacological mechanisms of, candidate drug-induced emesis. Ad hoc Working Groups have already finalized protocols for testing the comprehensive in vitro arrhythmia assay (CiPA), an innovative paradigm for assessing mechanisms conferring candidate drug proarrhythmic liabilities. EXPERT OPINION:The good concordance of non-clinical and clinical Phase I BP and HR effects of candidate drugs support the use of dog/monkey models for clinical outcome. Drug liabilities (e.g., PN, nausea, vomiting, etc.) affecting non-vital organs/systems require the same degree of SP attention given to vital functions as they can dramatically reduce patient quality of life.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Cavero Idoi
10.1517/14740338.2015.1034104subject
Has Abstractpub_date
2015-06-01 00:00:00pages
999-1008issue
6eissn
1474-0338issn
1744-764Xjournal_volume
14pub_type
abstract:INTRODUCTION:Pharmacologic vitreolysis is a strategy used to treat anomalous posterior vitreous detachment, by weakening vitreoretinal adhesion with an intravitreal drug. Pharmacologic vitreolysis facilitates surgery, and abnormalities of the vitreoretinal interface including vitreomacular traction (VMT) and early stag...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1208169
更新日期:2016-09-01 00:00:00
abstract:OBJECTIVE:Attention deficit hyperactivity disorder (ADHD) is the most common psychiatric childhood disorder. The most commonly used drugs in the treatment of ADHD are methylphenidate (MPH) and atomoxetine (ATX); the former of the two is prescribed in USA more than it is in Western Europe. Some of the most important saf...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2014.941804
更新日期:2014-09-01 00:00:00
abstract::Objectives: To examine the signals of bullous pemphigoid (BP) with dipeptidyl peptidase-4 inhibitors (DPP-4i) in VigiBase® and the potential role of their pharmacodynamic/pharmacokinetic parameters in the occurrence of BP. Methods: Case/non-case analyses were performed in VigiBase® to examine the signal of BP [reporti...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1668373
更新日期:2019-11-01 00:00:00
abstract::Black cohosh (Actaea racemosa/Cimicifuga racemosa) is a North American perennial plant that has been used for traditional medicinal purposes by the native Indian population. Its modern day application is the treatment of menopausal symptoms. Unlike conventional non-herbal medications, herbal preparations have not been...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.3.6.615
更新日期:2004-11-01 00:00:00
abstract:INTRODUCTION:The polycystic ovary syndrome (PCOS) is a very prevalent disorder in premenopausal women. Cardiovascular risk factors cluster in these patients, raising concern about the safety of the drugs commonly used to ameliorate symptoms of androgen excess in in this population at risk of cardiovascular morbidity. ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1839409
更新日期:2020-12-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to investigate whether the use of statins was associated with breast cancer risk. BACKGROUND:Experimental studies have shown that statins have potential protective effects against cancer. METHODS:We conducted a population-based case-control study in Taiwan. Cases consisted of all p...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2014.885949
更新日期:2014-03-01 00:00:00
abstract::Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly accessible database to describe the volume and expectedness of...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1676724
更新日期:2019-12-01 00:00:00
abstract:INTRODUCTION:Gestational diabetes mellitus (GDM), the most frequent medical complication of pregnancy, is associated with several adverse outcomes over the short- and long-term for both mother and offspring. Standard treatment for GDM consists of insulin injections. Oral hypoglycemic agents (OHAs), on the other hand, a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.521740
更新日期:2011-03-01 00:00:00
abstract:INTRODUCTION:Acne is a common skin condition of the pilosebaceous units that affects the young and old, ranges from moderate to severe and can be treated with an array of options. Topical retinoids are the initial treatment for acne due to their ability to treat comedones, the starting point of acne. AREAS COVERED:Taz...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2016.1117605
更新日期:2016-01-01 00:00:00
abstract:INTRODUCTION:Approximately 40-50% of patients with cutaneous melanoma harbor point mutations in BRAF. BRAF and MEK inhibitors in combination are now a standard therapy for advanced BRAFV600-mutated melanoma. Nevertheless, survival rates with the combination are limited, highlighting the need for further therapeutic imp...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1817376
更新日期:2020-10-01 00:00:00
abstract:INTRODUCTION:Emergency contraception (EC) is a way to significantly reduce the chance of becoming pregnant after an episode of unprotected intercourse. Considerable data support the safety of all available and emerging options for EC. Areas covered: This review presents a comprehensive summary of the literature regardi...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1354985
更新日期:2017-10-01 00:00:00
abstract::Introduction: Rucaparib is increasingly being utilized for women with recurrent ovarian cancer both as treatment and maintenance therapy. Poly-ADP ribose polymerase (PARP) inhibitors like rucaparib are daily oral medication that exploit the DNA repair pathway. The most significant clinical benefit is in those tumors e...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1550067
更新日期:2018-12-01 00:00:00
abstract::Of the numerous topics discussed during the eighth annual meeting of the Safety Pharmacology (SP) Society the author identified the following key topics: i) the impact of hERG (human ether-à-go-go related gene) channel data on drug development, ii) safety evaluation of biological products, iii) opportunities and expec...
journal_title:Expert opinion on drug safety
pub_type:
doi:10.1517/14740330902760360
更新日期:2009-03-01 00:00:00
abstract::Given the fact that as many as 9% of all adverse drug reactions involve toxic effects on the liver and with upwards of 50% of all cases of fulminant hepatic failure being ascribed to acetaminophen and other agents, the safe use of medications takes on an even greater importance whenever the prescription of potentially...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.1.2.159
更新日期:2002-07-01 00:00:00
abstract:INTRODUCTION:Clozapine was first introduced as an antipsychotic in the 1970's but a cluster of deaths, later linked to the drug's risk of agranulocytosis, led to its withdrawal in most countries. However, work in the 1980's established its unique efficacy in treatment resistant schizophrenia (TRS), which constitutes as...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1191468
更新日期:2016-09-01 00:00:00
abstract:OBJECTIVES:Our aim was to investigate the ADR reports of drugs with a monitoring registry (MR drugs), in particular those related to abuse/misuse, medication error, overdose, which might indicate an unsafe use. We compared these reports with those of similar drugs without a registry (non-MR drugs), thus verifying wheth...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2016.1248942
更新日期:2016-12-01 00:00:00
abstract:INTRODUCTION:The emergence of multidrug-resistant (MDR) infections has been extensively observed worldwide and has become a priority issue over past decade. Tigecycline , a broad spectrum antibiotic covering against many MDR organisms, has been widely used. However, recent meta-analysis studies have raised a concern fo...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.997206
更新日期:2015-02-01 00:00:00
abstract:BACKGROUND:Clinical data on the long-term safety and efficacy of infliximab on psoriatic patients who are older than 65 years are limited. OBJECTIVES:The aim is to report the long-term efficacy, safety and tolerance of infliximab in geriatric patients. METHODS:This was a retrospective study conducted at the Departmen...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2016.1226279
更新日期:2016-11-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Atorvastatin is the most widely used statin administered in a variety of settings, including primary and secondary prevention of cardiovascular events, in the elderly, in patients with chronic kidney disease and in diabetic patients. Therefore, the safety and tolerability of atorvastatin is of p...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2010.495385
更新日期:2010-07-01 00:00:00
abstract:INTRODUCTION:Unintended harm from prescribing errors remains a prevalent concern in healthcare leading to significant morbidity and mortality around the world. Prescribers face new challenges to their practice in modern times such as increasingly complex health-care systems, an aging population with increasing multimor...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1571038
更新日期:2019-02-01 00:00:00
abstract:INTRODUCTION:Since calcitonin gene-related peptide (CGRP) plays an important role in the pathophysiology of migraine via the activation of the trigeminovascular system, the newest prophylactic treatments directly block CGRP or its receptor. However, the safety of these novel antimigraine drugs is not yet sufficiently e...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1811229
更新日期:2020-10-01 00:00:00
abstract::Recombinant activated Factor VII (rFVIIa) has been successfully used in the treatment of haemophilia A and B with associated inhibitors for some years. Activated Factor VII binds to activated platelets independently of tissue factor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.3.557
更新日期:2005-05-01 00:00:00
abstract:INTRODUCTION:In settings where HIV is prevalent in heterosexual populations, pregnancy and postpartum breastfeeding periods can be associated with substantial HIV acquisition risk. Pre-exposure prophylaxis (PrEP) with daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine is an attractive HIV prevention option fo...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1338271
更新日期:2017-07-01 00:00:00
abstract:INTRODUCTION:Carbonic anhydrase (CA) inhibitors have an impressive safety record despite the multiple functions that CA isozymes serve because they are not fully inhibited with most dosing. While reducing the targeted CA-dependent process sufficiently for disease control, residual activity and uncatalyzed rates in comb...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.897328
更新日期:2014-04-01 00:00:00
abstract:OBJECTIVE:Further understand the safety profile of celecoxib and provide safety information for important adverse events (AEs). METHODS:Analysis of randomized controlled trials from the Pfizer clinical trial repository (final study reports completed by 31 July 2011) in which celecoxib was compared with placebo or non-...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析
doi:10.1517/14740338.2013.780595
更新日期:2013-07-01 00:00:00
abstract::Introduction: Secukinumab is a fully human monoclonal antibody which targets and neutralizes interleukin (IL)-17A, a cytokine that plays an important role in the pathophysiology of ankylosing spondylitis (AS). Secukinumab is the first IL-17A inhibitor approved for the treatment of AS. Areas covered: This paper aimed t...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2021.1851363
更新日期:2021-01-20 00:00:00
abstract::Background: This study aimed to measure the association of various H1-antihistamines (H1A) with Torsade de Pointes (TdP), and present a comprehensive overview of H1A-induced TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: All H1A-induced TdP cases (n = 406) were ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2021.1846717
更新日期:2021-01-01 00:00:00
abstract::Aerosolized delivery of a number of antimicrobial agents has been studied. Despite a theoretical soundness behind this strategy, full consideration of the potential toxicities associated with this mode of administration is imperative. Aerosolized amphotericin B, as both deoxycholate and lipid formulations, has been st...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.5.523
更新日期:2007-09-01 00:00:00
abstract::The objective of this review is to describe psychiatric adverse events occurring after ingestion of dietary supplements containing herbal ephedra and to assess the possible relationship between supplement use and the events. The authors reviewed all adverse event reports related to dietary supplements containing herba...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.5.879
更新日期:2005-09-01 00:00:00
abstract:INTRODUCTION:A growing number of children globally are being treated for multidrug-resistant tuberculosis (MDR-TB). The second-line injectable antituberculosis medications amikacin, kanamycin and capreomycin, traditionally a mainstay of MDR-TB treatment, cause important adverse effects including permanent sensorineural...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1223623
更新日期:2016-11-01 00:00:00