Bismuth Concentrations in Patients Treated in Real-Life Practice with a Bismuth Subcitrate-Metronidazole-Tetracycline Preparation: The SAPHARY Study
ConclusionsIn this study measuring blood bismuth concentrations in real-life practice, in    50 μg/L. No serious neurological adverse events were observed.Study registrationEU-PAS register EUPAS3142 atwww.encepp.eu; ENCePP study seal. (Source: Drug Safety)
Source: Drug Safety - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

Inflammation, Monoclonal Antibodies and Depression: Joining the Dots
(Source: Drug Safety)
Source: Drug Safety - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

A Profile of Adverse Drug Reactions of Atazanavir- and Lopinavir-Based Antiretroviral Regimens in Namibia
(Source: Drug Safety)
Source: Drug Safety - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

Advances in Diagnosis and Management of Cutaneous Adverse Drug Reactions: Current and Future Trends
(Source: Drug Safety)
Source: Drug Safety - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity
AbstractPharmacovigilance currently faces several unsolved challenges. Of particular importance are issues concerning how to ascertain, collect, confirm, and communicate the best evidence to assist the clinical choice for individual patients. Here, we propose that these practical challenges partially stem from deeper fundamental issues concerning the epistemology of pharmacovigilance. After reviewing some of the persistent challenges, recent measures, and suggestions in the current pharmacovigilance literature, we support the argument that the detection of potential adverse drug reactions ought to be seen as a serendipitou...
Source: Drug Safety - May 6, 2019 Category: Drugs & Pharmacology Source Type: research

Identifying the DEAD: Development and Validation of a Patient-Level Model to Predict Death Status in Population-Level Claims Data
ConclusionsUS claims data often lack complete death records. The DEAD model can be used to impute death at various sensitivity, specificity, or positive predictive values depending on the use of the model. The DEAD model can be readily applied to any observational healthcare database mapped to the Observational Medical Outcome Partnership common data model and is available fromhttps://github.com/OHDSI/StudyProtocolSandbox/tree/master/DeadModel. (Source: Drug Safety)
Source: Drug Safety - May 3, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists
In the original publication of this article, the following correction should be noted in Table  1. (Source: Drug Safety)
Source: Drug Safety - April 30, 2019 Category: Drugs & Pharmacology Source Type: research

The 10th International Congress on Cutaneous Adverse Drug Reactions, Shimane, Japan, 2018: Focus on New Discoveries
(Source: Drug Safety)
Source: Drug Safety - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Mechanisms of Severe Cutaneous Adverse Reactions: Recent Advances
AbstractCutaneous adverse drug reactions are unpredictable and include various different skin conditions of varying degrees of severity. The most concerning are usually referred to as severe cutaneous adverse reactions (SCARs) and include acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), also known as drug-induced hypersensitivity syndrome (DiHS) or hypersensitivity syndrome (HSS), Stevens –Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). All are delayed type IV hypersensitivity reactions in which a T-cell-mediated drug-specific immune respon...
Source: Drug Safety - April 24, 2019 Category: Drugs & Pharmacology Source Type: research

Standardising the Classification of Harm Associated with Medication Errors: The Harm Associated with Medication Error Classification (HAMEC)
AbstractClassifying harm associated with a medication error can be time consuming and labour intensive and limited studies undertake this step. There is no standardised process, and few studies that report harm assessment provide adequate methods to allow for study replication. Studies typically mention that a clinical review panel classified patient harm and provide a reference to a classification tool. Moreover, in many studies it is unclear whether potential or actual harm was classified as studies refer only to ‘error severity’. The tools used to categorise the severity of patient harm vary widely across st...
Source: Drug Safety - April 23, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn ’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
In the original publication of this article, the following correction should be noted in Table  5. (Source: Drug Safety)
Source: Drug Safety - April 22, 2019 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis
AbstractIntroductionDespite the numerous studies investigating drug-induced anaphylaxis (DIA), understanding and quantitative data analysis in developing countries remain limited. The aim of our study is to describe and quantify DIA using the National Pharmacovigilance Database of Vietnam (NPDV).MethodsSpontaneous reporting of adverse drug reactions (ADRs) recorded between 2010 and 2016 were retrospectively analysed to identify DIA reports. The trend and characteristics of DIA cases were described. Multivariate disproportionality analysis was used for signal generation.ResultsOverall, 4873 DIA cases (13.2% of total ADRs) w...
Source: Drug Safety - April 21, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries
AbstractPharmacovigilance has received much attention in Arab countries recently due to the development of new regulations. However, there are differences in the progression of pharmacovigilance systems by regulatory agencies in these countries because only some are able to meet the requirements for conducting pharmacovigilance activities. Only 45% of Arab countries are official members of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. Countries such as Morocco, Tunisia, Saudi Arabia, Egypt, and Jordan are considered to be advanced pharmacovigilance countries, whereas other coun...
Source: Drug Safety - April 20, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: A Machine-Learning Algorithm to Optimise Automated Adverse Drug Reaction Detection from Clinical Coding
CK: Principal Investigator. CM and CK were responsible for the study design and conception; all authors were responsible for acquisition and validation of the data; CM was responsible for analysis and interpretation of the data; and all authors contributed to reviewing drafts of the manuscript and approved the final version for publication. (Source: Drug Safety)
Source: Drug Safety - April 15, 2019 Category: Drugs & Pharmacology Source Type: research

Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists
This article reviews the major anti-obesity drugs and the benefit-risk profiles of the long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RAs) liraglutide and semaglutide (a modified version of liraglutide with longer half-life and tripled receptor affinity). Generally, GLP-1 RAs are well tolerated and induce significant weight loss and lowering of comorbidities. Studies with liraglutide 3.0 mg/day have shown an average placebo-subtracted weight loss of 5.5 kg (range 4.6–5.9) in 1- to 3-year duration trials. One trial using semaglutide 0.4 mg once daily report ed an average weight loss o...
Source: Drug Safety - April 10, 2019 Category: Drugs & Pharmacology Source Type: research

Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis
ConclusionsFecal microbiota transplantation should be a safe and promising therapy for ulcerative colitis. The improved fecal microbiota preparation and colonic transendoscopic enteral tubing might reduce the rate of adverse events in ulcerative colitis.Trial registrationClinicalTrials.gov NCT01790061, NCT02560727. (Source: Drug Safety)
Source: Drug Safety - April 10, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Antipsychotic Prescribing to Patients Diagnosed with Dementia Without a Diagnosis of Psychosis in the Context of National Guidance and Drug Safety Warnings: Longitudinal Study in UK General Practice
This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License. (Source: Drug Safety)
Source: Drug Safety - April 8, 2019 Category: Drugs & Pharmacology Source Type: research

Advances in Epidemiological Methods and Utilisation of Large Databases: A Methodological Review of Observational Studies on Central Nervous System Drug Use in Pregnancy and Central Nervous System Outcomes in Children
ConclusionMultiple factors, including different study designs and data sources, have led to inconsistent findings in associations between CNS drug use in pregnancy and CNS outcomes in children. Researchers should allow for study designs with clearly defined exposure periods, at the very least in trimesters, and use advanced confounding adjustment methodology to increase the accuracy of the findings. (Source: Drug Safety)
Source: Drug Safety - April 1, 2019 Category: Drugs & Pharmacology Source Type: research

Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review
ConclusionTwo existing algorithms based on medical claims diagnoses with or without death certificates can accurately identify SCD to support pharmacoepidemiologic studies. Developing valid algorithms identifying MI- and stroke-related death should be a research priority. PROSPERO 2017 CRD42017078745. (Source: Drug Safety)
Source: Drug Safety - April 1, 2019 Category: Drugs & Pharmacology Source Type: research

Comment on ‘Evaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron(III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase™ Between 2014 and 2017’
(Source: Drug Safety)
Source: Drug Safety - April 1, 2019 Category: Drugs & Pharmacology Source Type: research

Authors ’ reply to Schaffalitzky de Muckadell and colleague’s Comment on “Evaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron (III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase™ between 2014 and 2017”
(Source: Drug Safety)
Source: Drug Safety - April 1, 2019 Category: Drugs & Pharmacology Source Type: research

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe
AbstractThe Innovative Medicines Initiative (IMI) WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues. Two of the objectives were to develop principles for continuous monitoring of the safety of medicines without overburdening established pharmacovigilance systems and to propose a regulatory framework on the use of social media in pharmacovigilance. As a starting point, a review of existin...
Source: Drug Safety - March 30, 2019 Category: Drugs & Pharmacology Source Type: research

Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR
AbstractOver a period of 3 years, the European Union ’s Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions;https://web-radr.eu/) project explored the value of two digital tools for pharmacovigilance (PV): mobile applications (apps) for reporting the adverse effects of drugs and social media data for its contribution to safety signalling. The ultimate intent of WEB-RADR was to provide policy, technical and ethical recommendations on how to develop and implement such digital tools to enhance patient safety. Recommendations relating to the use of mobile apps for PV are summarised in this paper....
Source: Drug Safety - March 25, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues
The article “vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues”. (Source: Drug Safety)
Source: Drug Safety - March 25, 2019 Category: Drugs & Pharmacology Source Type: research

Summary of Torsades de Pointes (TdP) Reports Associated with Intravenous Drug Formulations Containing the Preservative Chlorobutanol
ConclusionThe pharmacologic profile of chlorobutanol (synergistic IKR block) and its association with reports of TdP and QT prolongation suggest the need for a full evaluation of its cardiac safety when used as a preservative in IV drug and vitamin formulations. (Source: Drug Safety)
Source: Drug Safety - March 19, 2019 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Photosensitivity —An Update: Culprit Drugs, Prevention and Management
AbstractPhotosensitive drug eruptions are cutaneous adverse events due to exposure to a medication and either ultraviolet or visible radiation. In this review, the diagnosis, prevention and management of drug-induced photosensitivity is discussed. Diagnosis is based largely on the history of drug intake and the appearance of the eruption primarily affecting sun-exposed areas of the skin. This diagnosis can also be aided by tools such as phototesting, photopatch testing and rechallenge testing. The mainstay of management is prevention, including informing patients of the possibility of increased photosensitivity as well as ...
Source: Drug Safety - March 19, 2019 Category: Drugs & Pharmacology Source Type: research

Sirolimus and mTOR Inhibitors: A Review of Side Effects and Specific Management in Solid Organ Transplantation
This article reviews the adverse effects of mTOR inhibitors in solid organ transplantation, with special attention given to mechanisms hypothesized to cause adverse events and their management strategies. (Source: Drug Safety)
Source: Drug Safety - March 13, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues
The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Nor én. Marie Lindquist, was originally published Online First without open access (Source: Drug Safety)
Source: Drug Safety - March 12, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Implications of Individual QT/RR Profiles —Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections
The Open Access license, which previously read: (Source: Drug Safety)
Source: Drug Safety - March 9, 2019 Category: Drugs & Pharmacology Source Type: research

Benefit –Risk Assessment of Vedolizumab in the Treatment of Crohn’s Disease and Ulcerative Colitis
AbstractVedolizumab, a humanized monoclonal antibody to the α4β7 integrin, reduces lymphocyte trafficking to the intestine. This gut-selective mechanism of action offers a safer alternative to other biologics used to treat ulcerative colitis (UC) and Crohn’s disease (CD). We reviewed efficacy and safety data from randomized controlled trials (RCTs), open -label extension (OLE) and observational studies, and pooled analyses of vedolizumab therapy. In UC, RCTs demonstrate that vedolizumab is effective for induction and maintenance of remission, regardless of prior tumor necrosis factor (TNF) antagonist expos...
Source: Drug Safety - March 4, 2019 Category: Drugs & Pharmacology Source Type: research

Established and Emerging Immunological Complications of Biological Therapeutics in Multiple Sclerosis
AbstractBiologic immunotherapies have transformed the treatment landscape of multiple sclerosis. Such therapies include recombinant proteins (interferon beta), as well as monoclonal antibodies (natalizumab, alemtuzumab, daclizumab, rituximab and ocrelizumab). Monoclonal antibodies show particular efficacy in the treatment of the inflammatory phase of multiple sclerosis. However, the immunological perturbations caused by biologic therapies are associated with significant immunological adverse reactions. These include development of neutralising immunogenicity, secondary immunodeficiency and secondary autoimmunity. These com...
Source: Drug Safety - March 4, 2019 Category: Drugs & Pharmacology Source Type: research

The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?
AbstractEnormous progress has been made globally in the use of evidence derived from patients ’ clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study p opulations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, clai...
Source: Drug Safety - March 1, 2019 Category: Drugs & Pharmacology Source Type: research

Potential Direct Costs of Adverse Drug Events and Possible Cost Savings Achievable by their Prevention in Tuscany, Italy: A Model-Based Analysis
ConclusionsThe present simulation showed that ADEs could have a relevant economic impact on the Tuscan healthcare system. In this setting, the prevention of ADEs would result in important cost savings. These results could be likely extended to other healthcare systems. (Source: Drug Safety)
Source: Drug Safety - March 1, 2019 Category: Drugs & Pharmacology Source Type: research

Implications of Individual QT/RR Profiles —Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections
ConclusionSubject-specific heart rate corrections based on limited baseline drug-free data may lead to inconsistent results and, in the presence of underlying heart rate changes, may potentially underestimate or overestimate QTc interval changes. The population-specific corrections lead to results that are much more influenced by the combination of individual QT/RR patterns than by the actual QTc interval changes. Subject-specific heart rate corrections based on full profiles derived from drug-free baseline recordings with wide QT/RR distribution should be used when studying drugs expected to cause heart rate changes. (Source: Drug Safety)
Source: Drug Safety - March 1, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacovigilance in India: Present Scenario and Future Challenges
AbstractPharmacovigilance in India was initiated way back in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India. India joined the World Health Organization (WHO) Programme for International Drug Monitoring in 1998, but was not successful. Later, the National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. In consideration of having a robust pharmacovigilance system in India, steps were taken. The National Coordination Centre was shifted from New Delhi to the Indian Pharmacopoeia ...
Source: Drug Safety - March 1, 2019 Category: Drugs & Pharmacology Source Type: research

Implications of Individual QT/RR Profiles —Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes
ConclusionsThe lack of correlation of QTc versus RR durations including on-treatment data does not prove any validity of HR corrections. Correlations of QTc versus RR in study data pooling on- and off-drug measurements should not be used to prove the appropriateness of HR corrections. (Source: Drug Safety)
Source: Drug Safety - March 1, 2019 Category: Drugs & Pharmacology Source Type: research

Correcting QT for Heart Rate When Both are Affected by a Drug
(Source: Drug Safety)
Source: Drug Safety - March 1, 2019 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Steatosis and Steatohepatitis: The Search for Novel Serum Biomarkers Among Potential Biomarkers for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis
This article reviews the existing medical literature and other publically available information pertaining to novel serum biomarkers for NAFLD and NASH, and explores the concurrent identification of these biomarkers for DIS and DISH. (Source: Drug Safety)
Source: Drug Safety - February 14, 2019 Category: Drugs & Pharmacology Source Type: research

A Comparison Study of Algorithms to Detect Drug –Adverse Event Associations: Frequentist, Bayesian, and Machine-Learning Approaches
ConclusionOur results will be useful to help choose a method for a given desired level of specificity. Methods popular in the genome-wide association study literature did not perform well because of the sparsity of data and will need modification before their properties can be used in the drug –adverse event association problem. (Source: Drug Safety)
Source: Drug Safety - February 14, 2019 Category: Drugs & Pharmacology Source Type: research

Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn ’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
ConclusionsUstekinumab demonstrated a favorable and consistent safety profile across registrational trials in approved indications.Trial RegistrationsClinicalTrials.gov identifier: NCT00320216, NCT00267969, NCT00307437, NCT00454584, NCT00267956, NCT01009086, NCT01077362, NCT00265122, NCT00771667, NCT01369329, NCT01369342, and NCT01369355. (Source: Drug Safety)
Source: Drug Safety - February 9, 2019 Category: Drugs & Pharmacology Source Type: research

Use of FDA ’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure
ConclusionOur study suggests risk among younger ranolazine patients is rare. Given the imprecision of the risk estimates, we interpret the elevated seizure risk following ranolazine exposure with caution. Further analysis in a larger elderly population is warranted. (Source: Drug Safety)
Source: Drug Safety - February 8, 2019 Category: Drugs & Pharmacology Source Type: research

Use of a Patient-Friendly Terms List in the Adverse Drug Reaction Report Form: A Database Study
ConclusionsMost people chose to describe adverse drug reactions in their own words rather than selecting adverse drug reactions from a patient-friendly terms list. Although the patient-friendly terms list may be a useful feature for some patients or for some adverse drug reactions, it should not replace the option for patients to describe adverse drug reactions in their own words. (Source: Drug Safety)
Source: Drug Safety - February 6, 2019 Category: Drugs & Pharmacology Source Type: research

A Machine-Learning Algorithm to Optimise Automated Adverse Drug Reaction Detection from Clinical Coding
ConclusionsAutomated ADR detection using ICD-10 coding significantly improved ADR detection in the study period, with improved discrimination between true and false reports by applying a machine-learning model. (Source: Drug Safety)
Source: Drug Safety - February 6, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Implications of Individual QT/RR Profiles —Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes
This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License which permits unrestricted use. (Source: Drug Safety)
Source: Drug Safety - February 6, 2019 Category: Drugs & Pharmacology Source Type: research

From Data Silos to Standardized, Linked, and FAIR Data for Pharmacovigilance: Current Advances and Challenges with Observational Healthcare Data
(Source: Drug Safety)
Source: Drug Safety - January 22, 2019 Category: Drugs & Pharmacology Source Type: research

Frailty and Drug Safety at Older Ages
(Source: Drug Safety)
Source: Drug Safety - January 19, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors in Oncology
AbstractTyrosine kinase inhibitors (TKIs) that target epidermal growth factor receptor (EGFR) have dramatically improved progression-free survival in non-small-cell lung cancer (NSCLC) patients who carry sensitizing EGFR-activating mutations and in patients with breast and pancreatic cancers. However, EGFR-TKIs are associated with significant and disabling undesirable effects that adversely impact on quality of life and compliance. These effects include dermatological reactions, diarrhoea, hepatotoxicity, stomatitis, interstitial lung disease and ocular toxicity. Each individual EGFR-TKI is also associated with additional ...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Histone Deacetylase (HDAC) Inhibitors in Oncology
AbstractHistone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently approved under various jurisdictions, namely belinostat, chidamide, panobinostat, romidepsin and vorinostat. These agents are associated with a range of class-related and agent-specific serious and/or severe adverse effects, notably myelosuppression, diarrhoea and various cardiac effects. Among the cardiac...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Phosphatidylinositol-3-Kinase (PI3K) Inhibitors in Oncology
AbstractActivation of phosphatidylinositol-3-kinase (PI3K) and downstream signalling by AKT/mammalian target of rapamycin (mTOR) modulates cellular processes such as increased cell growth, cell proliferation and increased cell migration as well as deregulated apoptosis and oncogenesis. The PI3K/AKT/mTOR pathway (particularly Class  I PI3K isoforms) is frequently activated in a variety of solid tumours and haematological malignancies, making PI3K an attractive therapeutic target in oncology. Inhibitors of PI3K also have the potential to restore sensitivity to other modalities of treatments when administered as part of ...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Antibody-Drug Conjugates in Cancer
AbstractAntibody-drug conjugates are monoclonal antibodies attached to biologically active drugs through chemical linkers that deliver and release cytotoxic agents at the tumor site, reducing the likelihood of systemic exposure and therefore toxicity. Currently, there are about 110 ongoing studies implementing antibody-drug conjugates in the treatment of multiple human malignancies. Antibody-drug conjugates carry a feature of the specificity of a monoclonal antibody and the anti-neoplastic potential of a cytotoxin. The first antibody-drug conjugate was approved in 2001, and the field of antibody-drug conjugates has expande...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research