Safety Pharmacology Society: 8th annual meeting.

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 Saf

authors

Cavero I,Safety Pharmacology Society.

doi

10.1517/14740330902760360

subject

Has Abstract

pub_date

2009-03-01 00:00:00

pages

237-47

issue

2

eissn

1474-0338

issn

1744-764X

journal_volume

8

pub_type

  • Safety of secukinumab for the treatment of active ankylosing spondylitis.

    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

    authors: Loricera J,Galíndez-Aguirregoikoa E,Blanco R

    更新日期:2021-01-20 00:00:00

  • The safety of rosiglitazone in the treatment of type 2 diabetes.

    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

    authors: Singh S,Loke YK

    更新日期:2008-09-01 00:00:00

  • Phosphate binders for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis: a comparison of safety profiles.

    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

    authors: Locatelli F,Del Vecchio L,Violo L,Pontoriero G

    更新日期:2014-05-01 00:00:00

  • High-dose interleukin-2 (IL-2) for the treatment of melanoma: safety considerations and future directions.

    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

    authors: Marabondo S,Kaufman HL

    更新日期:2017-12-01 00:00:00

  • Osteonecrosis of the jaw: what do bisphosphonates do?

    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

    authors: Aspenberg P

    更新日期:2006-11-01 00:00:00

  • Conjugated estrogens for the treatment of menopausal symptoms: a review of safety data.

    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

    authors: Mirkin S,Komm BS,Pickar JH

    更新日期:2014-01-01 00:00:00

  • Hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis and its safety in pregnancy.

    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

    authors: Abarientos C,Sperber K,Shapiro DL,Aronow WS,Chao CP,Ash JY

    更新日期:2011-09-01 00:00:00

  • Safety and efficacy evaluation of albumin-bound paclitaxel.

    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

    authors: Cecco S,Aliberti M,Baldo P,Giacomin E,Leone R

    更新日期:2014-04-01 00:00:00

  • Fixed-dose combinations banned in India: is it the right decision? An eye-opening review.

    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

    authors: Miranda MRH,Dubey A,G S R,Charyulu RN

    更新日期:2019-10-01 00:00:00

  • Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety.

    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

    authors: Cuzzolin L,Atzei A,Fanos V

    更新日期:2006-09-01 00:00:00

  • Unresolved gustatory, olfactory and auditory adverse drug reactions to antibiotic drugs: a survey of spontaneous reporting to Eudravigilance.

    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

    authors: Ferraro S,Convertino I,Leonardi L,Blandizzi C,Tuccori M

    更新日期:2019-12-01 00:00:00

  • Disproportionality analysis of bullous pemphigoid adverse events with PD-1 inhibitors in the FDA adverse event reporting system.

    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

    authors: Aggarwal P

    更新日期:2019-07-01 00:00:00

  • Do we need to worry about mycophenolate overdose?

    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

    authors: Filler G,Ferrand A

    更新日期:2014-05-01 00:00:00

  • Risk of adverse events in lymphoma patients treated with brentuximab vedotin: a systematic review and meta-analysis.

    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

    authors: Gao S,Zhang M,Wu K,Zhu J,He Z,Li J,Chen C,Qiu K,Yu X,Wu J

    更新日期:2020-05-01 00:00:00

  • Safety and efficacy of paracetamol and NSAIDs in osteoarthritis: which drug to recommend?

    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

    authors: Richette P,Latourte A,Frazier A

    更新日期:2015-08-01 00:00:00

  • Pegylated-interferon-α(2a) in clinical practice: how to manage patients suffering from side effects.

    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

    authors: Calvaruso V,Mazza M,Almasio PL

    更新日期:2011-05-01 00:00:00

  • Drug safety evaluation of maraviroc for the treatment of HIV infection.

    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

    authors: Wasmuth JC,Rockstroh JK,Hardy WD

    更新日期:2012-01-01 00:00:00

  • Are drugs really toxic for older people?

    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

    authors: Beard K

    更新日期:2003-05-01 00:00:00

  • Safety analysis of sofosbuvir and ledipasvir for treating hepatitis C.

    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

    authors: Fazel Y,Lam B,Golabi P,Younossi Z

    更新日期:2015-08-01 00:00:00

  • Acute mycophenolate overdose: case series and systematic literature analysis.

    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

    authors: Ceschi A,Gregoriano C,Rauber-Lüthy C,Kupferschmidt H,Banner NR,Krähenbühl S,Taegtmeyer AB

    更新日期:2014-05-01 00:00:00

  • How safe is rucaparib in ovarian cancer?

    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

    authors: Cosgrove CM,O'Malley DM

    更新日期:2018-12-01 00:00:00

  • Prospects for MEK inhibitors for treating cancer.

    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

    authors: Martin-Liberal J,Lagares-Tena L,Larkin J

    更新日期:2014-04-01 00:00:00

  • Reassessing the safety of intravenous and compounded injectable colchicine in acute gout treatment.

    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

    authors: Schlesinger N

    更新日期:2007-11-01 00:00:00

  • The safety and tolerability of the second-line injectable antituberculosis drugs in children.

    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

    authors: Garcia-Prats AJ,Schaaf HS,Hesseling AC

    更新日期:2016-11-01 00:00:00

  • CGRP inhibitors for migraine prophylaxis: a safety review.

    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

    authors: Rivera-Mancilla E,Villalón CM,MaassenVanDenBrink A

    更新日期:2020-10-01 00:00:00

  • Irinotecan in the treatment of small cell lung cancer: a review of patient safety considerations.

    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

    authors: Kawahara M

    更新日期:2006-03-01 00:00:00

  • Policies to mitigate nonmedical use of prescription medications: how should emerging evidence of gabapentin misuse be addressed?

    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

    authors: Peckham AM,Fairman KA,Sclar DA

    更新日期:2018-05-01 00:00:00

  • Safety and tolerability of injectable lipid-lowering drugs: an update of clinical data.

    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

    authors: Strilchuk L,Fogacci F,Cicero AF

    更新日期:2019-07-01 00:00:00

  • Bleeding complications of unfractionated heparin.

    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

    authors: Krishnaswamy A,Lincoff AM,Cannon CP

    更新日期:2011-01-01 00:00:00

  • Adverse events associated with somatostatin analogs in acromegaly.

    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

    authors: Grasso LF,Auriemma RS,Pivonello R,Colao A

    更新日期:2015-08-01 00:00:00