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 expectations from SP, iv) human stem cell derived cardiomyocytes for safety assessment, v) role of cellular calcium pathways in drug-induced arrhythmias, vi) collaboration initiatives for finding solutions to cardiac repolarisation and other recognised SP risks, vii) Pharma and FDA perspectives on ICH S7B guideline, viii) joint PhRMA-FDA dialogue on drug abuse potential assessment, ix) frontloading SP strategies for mitigating non-clinical and clinical attrition; and x) approaches to measure non-clinical assay predictability for human outcome. The establishment of consortia to accelerate the solution of critical SP issues and the implementation of Frontloading SP or Exploratory SP strategies for an early selection of safe clinical candidates are promising avenues for consolidating SP as an indispensable drug development discipline and for transforming established regulatory SP investigations into a risk-known exercise.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Cavero I,Safety Pharmacology Society.doi
10.1517/14740330902760360subject
Has Abstractpub_date
2009-03-01 00:00:00pages
237-47issue
2eissn
1474-0338issn
1744-764Xjournal_volume
8pub_type
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:Cardiovascular disease is the leading cause of mortality among adults with Type 2 diabetes. The thiazolidinediones including rosiglitazone are approved for the treatment of Type 2 diabetes on the basis of their ability to lower blood sugar and surrogate markers of cardiovascular disease. OBJECTIVES:To ascer...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.7.5.579
更新日期:2008-09-01 00:00:00
abstract:INTRODUCTION:Hyperphosphatemia is common in the late stages of chronic kidney disease (CKD) and is associated with elevated parathormone levels, abnormal bone mineralization, extraosseous calcification and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.907791
更新日期:2014-05-01 00:00:00
abstract:INTRODUCTION:In 1998, high-dose interleukin-2 (IL-2) was the first immunotherapy approved for the treatment of metastatic melanoma based on durable objective responses documented in a subset of patients but widespread utilization was limited by significant toxicity. Advances in targeted therapy and the emergence of T c...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1382472
更新日期:2017-12-01 00:00:00
abstract::Osteonecrosis of the jaw is a new disease, partly caused by bisphosphonates. It is commonly assumed that the bisphosphonates somehow cause cell death (osteocyte necrosis) within the jawbone, which makes it prone to chronic infection. In this article, an alternative pathogenetic theory is suggested, based on the normal...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.5.6.743
更新日期:2006-11-01 00:00:00
abstract:INTRODUCTION:Conjugated equine estrogens (CEE) are widely used for the treatment of menopausal symptoms, such as vasomotor symptoms and vulvovaginal atrophy, and for the prevention of bone loss, in postmenopausal women. The safety profile of CEE has been extensively published over the past 20 years. AREAS COVERED:Data...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.824965
更新日期:2014-01-01 00:00:00
abstract:INTRODUCTION:The antimalarial drug hydroxychloroquine (HCQ) is widely used to treat various rheumatic diseases. Many autoimmune diseases occur in women of child-bearing age who may become pregnant while on therapy, which raises concerns regarding the teratogenicity of HCQ and its effect on the outcome of the pregnancy....
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.566555
更新日期:2011-09-01 00:00:00
abstract:INTRODUCTION:Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel, which was developed to avoid toxicities associated with Cremophor EL® vehicle used in solvent-based paclitaxel. It is approved as monotherapy for treatment of metastatic breast cancer (MBC) in Europe a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.893293
更新日期:2014-04-01 00:00:00
abstract::Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1651292
更新日期:2019-10-01 00:00:00
abstract::This review aims to give an updated overview of the worldwide situation of off-label and unlicensed drug use in the paediatric field, also taking into account the safety of this kind of treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.5.703
更新日期:2006-09-01 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::Objectives: Bullous pemphigoid, an autoimmune dermatological disease, may be associated with the use of a relatively new anti-cancer drug class, PD-1 inhibitors, which includes pembrolizumab and nivolumab. This paper analyzes the signals between PD-1 inhibitors and bullous pemphigoid based upon the reported real-world...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1619693
更新日期:2019-07-01 00:00:00
abstract:INTRODUCTION:To discuss the significance of the recent observational case series from the Swiss Toxicological Information Centre (STIC). Mycophenolic acid (MPA) and its prodrug mycophenolate mofetil are immunosuppressive agents that are frequently prescribed in renal transplant recipients, and their safety profiles mus...
journal_title:Expert opinion on drug safety
pub_type: 评论,社论
doi:10.1517/14740338.2014.905540
更新日期:2014-05-01 00:00:00
abstract::Objectives: To assess the risk of adverse events (AEs) associated with brentuximab vedotin in lymphoma patients.Methods: Articles were retrieved from PubMed, Cochrane, and Clinicaltrials Databases to identify randomized controlled trials (RCTs) comparing brentuximab vedotin with non-brentuximab vedotin in lymphoma pat...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析
doi:10.1080/14740338.2020.1718103
更新日期:2020-05-01 00:00:00
abstract:INTRODUCTION:Osteoarthritis (OA) is the most common form of arthritis and is a major cause of disability, especially in people ≥ 45 years old. Several international societies recommend the use of both acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) to alleviate OA pain. However, patients with OA often ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.1056776
更新日期:2015-08-01 00:00:00
abstract:INTRODUCTION:The goal of antiviral therapy in patients with chronic hepatitis C is to slow or halt the progression of fibrosis and prevent the development of cirrhosis. Accordingly, antiviral treatment is proposed for a large population of patients with chronic hepatitis. AREAS COVERED:The standard-of-care for chronic...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.559161
更新日期:2011-05-01 00:00:00
abstract:INTRODUCTION:Maraviroc is the only C-chemokine receptor 5 (CCR5) antagonist approved for the treatment of infection with HIV. This article reviews the safety and efficacy of maraviroc in the treatment of HIV infection. AREAS COVERED:The PubMed database was searched using the keywords 'maraviroc' and 'HIV'. In addition...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.640670
更新日期:2012-01-01 00:00:00
abstract::Many diseases are now treatable with modern drugs. Elderly people, because they suffer from age-related illnesses, stand to gain the most, but they are also at risk from adverse drug reactions (ADRs). There are complex reasons for the increased frequency of ADRs, including poor prescribing, polypharmacy, altered drug ...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.2.3.211
更新日期:2003-05-01 00:00:00
abstract:INTRODUCTION:The approval of sofosbuvir (SOF), a nucleotide analogue NS5B polymerase inhibitor, and ledipasvir (LDV), a NS5A inhibitor, marked a new chapter in IFN and ribavirin-free treatment of hepatitis C virus (HCV). This drug reduces adverse events associated with IFN therapy. AREAS COVERED:The purpose of this pa...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.1053868
更新日期:2015-08-01 00:00:00
abstract:BACKGROUND:Literature regarding acute human toxicity of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) is limited. OBJECTIVES:Our objectives were to describe all cases of overdose with MMF or EC-MPS reported to the Swiss Toxicological Information Centre (STIC) or in the literature between...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析,评审
doi:10.1517/14740338.2014.903032
更新日期:2014-05-01 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:INTRODUCTION:The MAPK pathway is a signaling network that plays a key role in many normal cellular processes and in a large number of human malignancies. One of its effectors, MEK, is essential for the carcinogenesis of different tumors. In recent years, several drugs able to inhibit MEK have been assessed in clinical ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.892578
更新日期:2014-04-01 00:00:00
abstract::Colchicine has been used for over 2000 years. Intravenous (i.v.) colchicine has been used for the treatment of acute gout since the 1950s. I.v. and oral colchicine were 'grandfathered' before the 1969 FDA Phase III trials for drug toxicity became law. Data on toxic reactions are, therefore, based only on passive surve...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.6.625
更新日期:2007-11-01 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
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::A water soluble derivative of camptothecin, irinotecan (CPT-11) is effective against small-cell lung cancer (SCLC), as well as non-SCLC and gastrointestinal cancers. This extended review of recently concluded and ongoing studies focuses on irinotecan in the treatment of limited (LD) and extensive (ED) SCLC specificall...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.2.303
更新日期:2006-03-01 00:00:00
abstract:INTRODUCTION:Over the past decade, increased prescription supply has facilitated an epidemic of nonmedical use of controlled substances, including predominantly opioids, as well as benzodiazepines, z-hypnotics, and stimulants. Areas covered: More recently, misuse of noncontrolled prescriptions, such as gabapentin, has ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2017.1390081
更新日期:2018-05-01 00:00:00
abstract:INTRODUCTION:Cardiovascular (CV) diseases are the leading cause of death and disability in the developed countries. Lipid-lowering therapy is a cornerstone of the CV risk modification strategy. The first line treatment for hyperlipidemia is statins, which decrease low-density lipoprotein cholesterol (LDL-C) by 30-50% a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1620730
更新日期:2019-07-01 00:00:00
abstract:INTRODUCTION:Unfractionated heparin is an anticoagulant used in the treatment of myocardial infarction, pulmonary embolism and other thrombotic disorders. However, with anticoagulation comes the risk of bleeding and adverse events. These risks increase with supratherapeutic dosing. AREAS COVERED:In this review, we dis...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.521150
更新日期:2011-01-01 00:00:00
abstract:INTRODUCTION:In patients with acromegaly, somatostatin analogs (SSA) represent the first choice medical treatment. The long-acting SSA have been found to be effective in controlling growth hormone and IGF-I levels in a high percentage of patients, resulting in an improvement in the quality of life; moreover, these pept...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.1059817
更新日期:2015-08-01 00:00:00