An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System
ConclusionUnderstanding the origins and characteristics of ICSRs with an outcome of death supports meaningful evaluations and interpretations of FAERS data. A wide variability in ICSR quality exists, even in those reports with the most serious outcome. (Source: Drug Safety)
Source: Drug Safety - January 23, 2020 Category: Drugs & Pharmacology Source Type: research

Hyperkeratotic Skin Adverse Events Induced by Anticancer Treatments: A Comprehensive Review
AbstractHyperkeratotic skin adverse events are a group of toxic effects, characterized by the disruption of epidermal homeostasis and interaction with keratinocyte proliferation/differentiation or keratinocyte survival, and frequently reported with systemic anticancer treatments. These types of reactions include hand –foot skin reaction or palmoplantar keratoderma, induced psoriasis, keratosis pilaris-like or pityriasis rubra pilaris-like rashes, Grover’s disease, and contact hyperkeratosis. Cutaneous squamoproliferative lesions are also described because of the presence of abnormal keratinocyte proliferatio n....
Source: Drug Safety - January 23, 2020 Category: Drugs & Pharmacology Source Type: research

Contribution of Causality Assessment for an Automated Detection of Safety Signals: An Example Using the French Pharmacovigilance Database
ConclusionThe approach therefore appears useful as an additional tool for safety signal detection, especially for antineoplastic and immunomodulating agents. (Source: Drug Safety)
Source: Drug Safety - January 22, 2020 Category: Drugs & Pharmacology Source Type: research

Developing Predictive Models to Determine Patients in End-of-Life Care in Administrative Datasets
ConclusionThese results show that developing diagnostic predictive models for determining subjects in end-of-life care at the time of a drug treatment is possible and may improve the validity of the risk profile for those treatments. (Source: Drug Safety)
Source: Drug Safety - January 13, 2020 Category: Drugs & Pharmacology Source Type: research

A New President ’s Vision for International Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - January 13, 2020 Category: Drugs & Pharmacology Source Type: research

Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study
AbstractIntroductionAlthough the human epidermal growth factor receptor 2 (HER2) blocker trastuzumab is generally well tolerated, cardiotoxicity can be an important therapeutic limitation.ObjectiveIn this prespecified analysis, we compared the cardiac safety of the trastuzumab biosimilar ABP 980 (KANJINTI ™) and the trastuzumab reference product (RP; Herceptin®) in the phase III LILAC study (ClinicalTrials.gov identifier NCT01901146).MethodsIn the neoadjuvant phase of LILAC, after run-in chemotherapy, 725 patients were randomized 1:1 to ABP  980 (n = 364) or trastuzumab RP (n = 36...
Source: Drug Safety - January 10, 2020 Category: Drugs & Pharmacology Source Type: research

Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania
ConclusionsThe national pharmacovigilance systems in the four East African countries have policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the four national pharmacovigilance systems are at different levels of capacity and performance with respect to conducting pharmacovigilance activities. Targeted interventions are needed to strengthen the pharmacovigilance systems to enable evidence-based decision making for patient safety. (Source: Drug Safety)
Source: Drug Safety - January 8, 2020 Category: Drugs & Pharmacology Source Type: research

Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire
ConclusionAfter validation and testing, the developed questionnaire to study patient-reported adverse events of radiopharmaceuticals is a suitable and valid instrument which can be used in future research. (Source: Drug Safety)
Source: Drug Safety - January 7, 2020 Category: Drugs & Pharmacology Source Type: research

Utility of a Computerized ICD-10 Algorithm to Identify Idiosyncratic Drug-Induced Liver Injury Cases in the Electronic Medical Record
AbstractIntroductionIdiosyncratic drug-induced liver injury (DILI) is an important cause of liver injury that is difficult to diagnose and identify in the electronic medical record (EMR).ObjectiveOur objective was to develop a computerized algorithm that can reliably identify DILI cases from the EMR.MethodsThe EMR was searched for all encounters with anInternational Classification of Diseases, Tenth Revision (ICD-10) T code for drug toxicity and a K-71 code for toxic liver injury between 1 October 2015 and 30 September 2018. Clinically significant liver injury was defined using predetermined laboratory values. An expert op...
Source: Drug Safety - January 7, 2020 Category: Drugs & Pharmacology Source Type: research

Coronary Risks Associated with Diclofenac and Other NSAIDs: An Update
AbstractThe risk of coronary events with non-steroidal anti-inflammatory drugs has been the subject of much debate since the original trial of rofecoxib raised the issue. Since then, over almost 20  years, such risks have been shown in clinical trials of long-term high-dose users, and in observational studies comparing users with non-users. The roles of cyclooxygenase (COX)-2/COX-1 selectivity and COX-2 inhibitory potency have been proposed to explain this increased risk of myocardial infarct ion (MI). Among NSAIDs, diclofenac appeared to be associated with a relatively higher risk of MI, similar to that of rofecoxib,...
Source: Drug Safety - January 7, 2020 Category: Drugs & Pharmacology Source Type: research

Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility
ConclusionsOur model demonstrated the feasibility of developing a tool predictive of ICSR utility. The model ’s modest discriminative ability highlights opportunities for further enhancement and suggests algorithms tailored to safety issues may be beneficial. (Source: Drug Safety)
Source: Drug Safety - January 6, 2020 Category: Drugs & Pharmacology Source Type: research

Spontaneous Fluctuations in Liver Biochemistries in Patients with Compensated NASH Cirrhosis: Implications for Drug Hepatotoxicity Monitoring
We examined the laboratory values of patients with compensated cirrhosis randomized to placebo in two clinical trials for NASH. Patients in one study were followed every 13 weeks up to week 57; patients in the other study were followed every 4 weeks up to week 120.ResultsIn total, 53 and 85 patients were randomized to placebo in the trials. Baseline alanine aminotransferase (ALT) was greater than the laboratory upper limit of normal (ULN) in 53% and 49% of participants, aspartate aminotransferase (AST) was> ULN in 49% and 59%, alkaline phosphatase was> ULN in 36% and 27%, and bilirubin was>ULN in 13% and 19%. Duri...
Source: Drug Safety - January 5, 2020 Category: Drugs & Pharmacology Source Type: research

Brand-Specific Enhanced Safety Surveillance of GSK ’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season
ConclusionIn compliance with EMA guidance, this study design allowed for near real-time assessment of AEs. No safety signals were detected at any point during the study period. The study supports and confirms the acceptable safety profile of GSK ’s IIV4.ClinicalTrials.gov identifierNCT03688620. (Source: Drug Safety)
Source: Drug Safety - December 27, 2019 Category: Drugs & Pharmacology Source Type: research

The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK
ConclusionBrand name and batch number traceability for biologics in UK ADR reports are generally low. Shortcomings in the systematic recording of product details in UK clinical practice may contribute to the limited traceability. (Source: Drug Safety)
Source: Drug Safety - December 22, 2019 Category: Drugs & Pharmacology Source Type: research

Hypoglycemia Associated with Antibiotics Alone and in Combination with Sulfonylureas and Meglitinides: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS)
ConclusionIn many patients, antibiotics, including fluoroquinolones, are associated with hypoglycemia when they are also taking sulfonylureas or meglitinides. Cefditoren, tigecycline, ertapenem, and clarithromycin are associated with hypoglycemia even if not taken with sulfonylureas or meglitinides. The association between ertapenem and hypoglycemia has not been previously reported. (Source: Drug Safety)
Source: Drug Safety - December 19, 2019 Category: Drugs & Pharmacology Source Type: research

A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case –Control Analyses of Select Outcomes
ConclusionRisks for all-cause mortality, self-harm and suicide, and stroke in older patients may be higher among patients treated with quetiapine and antidepressant combination therapy. (Source: Drug Safety)
Source: Drug Safety - December 16, 2019 Category: Drugs & Pharmacology Source Type: research

Medical Devices: Definition, Classification, and Regulatory Implications
AbstractWe propose the following definition of a medical device: “A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional.” Current regulatory classifications of medical devices are complex and designed primarily for regulators. We propose a simpler classification, based on (1) the site of application of the devi ce, (2) the time scale of its use, and (3) whether it has an external power source. The regulation of medical devices is less well developed than the regulation of medicinal products, which it could follow more closely. In particular, devices that incorpor...
Source: Drug Safety - December 15, 2019 Category: Drugs & Pharmacology Source Type: research

The Use of Long-Acting Insulin Analogs and the Risk of Colorectal Cancer Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
ConclusionsThe results of this population-based study indicate that use of long-acting insulin analogs is not associated with an overall increased risk of colorectal cancer. (Source: Drug Safety)
Source: Drug Safety - December 13, 2019 Category: Drugs & Pharmacology Source Type: research

Follow-Up on the Use of Machine Learning in Clinical Quality Assurance: Can We Detect Adverse Event Under-Reporting in Oncology Trials?
(Source: Drug Safety)
Source: Drug Safety - December 12, 2019 Category: Drugs & Pharmacology Source Type: research

Insight into the Severity of Adverse Drug Reactions as Experienced by Patients
(Source: Drug Safety)
Source: Drug Safety - December 12, 2019 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Hypophosphatemia: Current Insights
AbstractPhosphate is actively involved in many important biochemical pathways, such as energy and nucleic acid metabolism, cellular signaling, and bone formation. Hypophosphatemia, defined as serum phosphate levels below 2.5  mg/dL (0.81 mmol/L), is frequently observed in the course of treatment with commonly used drugs, such as diuretics, bisphosphonates, antibiotics, insulin, and antacids. Furthermore, this undesired effect may complicate the use of several novel medications, including teriparatide, denosumab, paren teral iron, and antiviral and antineoplastic agents. This review addresses drug-associated hypop...
Source: Drug Safety - November 26, 2019 Category: Drugs & Pharmacology Source Type: research

Fatal Toxicity Indices for Medicine-Related Deaths in New Zealand, 2008 –2013
ConclusionNew Zealand prescribers should be aware of the high relative risk of death associated with methadone and clozapine; that clomipramine, dosulepin and doxepin were identified as the most dangerous antidepressants; and that zopiclone carries a similar fatal risk to benzodiazepines. Varying results were found between the FTIs calculated, making comparisons, particularly between populations, difficult. (Source: Drug Safety)
Source: Drug Safety - November 19, 2019 Category: Drugs & Pharmacology Source Type: research

The Role of Unit-Dose Child-Resistant Packaging in Unintentional Childhood Exposures to Buprenorphine –Naloxone Tablets
(Source: Drug Safety)
Source: Drug Safety - November 19, 2019 Category: Drugs & Pharmacology Source Type: research

Prenatal Exposure to Macrolides and Risk of Congenital Malformations: A Meta-Analysis
ConclusionsOur study suggests a weak association between prenatal use of macrolides and congenital malformations, limited to exposure in early pregnancy, and musculoskeletal and digestive systems. In addition to studies with a larger control of confounding, risk –benefit research is needed to determine the usefulness of macrolides during pregnancy. (Source: Drug Safety)
Source: Drug Safety - November 11, 2019 Category: Drugs & Pharmacology Source Type: research

Rheumatology Common Toxicity Criteria (RCTC): An Update Reflecting Real-World Use
ConclusionThe RCTC 2.0 performed as intended, although some inaccuracies and omissions were found. We provide a corrected version, RCTC 2.1, and also recommend further revision of the RCTC within OMERACT guidances to include AEs that have been reported in rheumatology clinical trials since RCTC 2.0 was published. Ideally, a revised RCTC 3.0 would not only facilitate standardized assessment and reporting of AEs, but would also expand and encourage accurate comparison of the safety profiles of treatments for rheumatic/autoimmune diseases. (Source: Drug Safety)
Source: Drug Safety - November 5, 2019 Category: Drugs & Pharmacology Source Type: research

Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance
ConclusionsThe aRMMs as measured by the prescriber KAU were effective for most key safety messages; however, not all key messages of the aRMMs were stringently followed in routine practice. (Source: Drug Safety)
Source: Drug Safety - November 4, 2019 Category: Drugs & Pharmacology Source Type: research

Medical Devices: Classification and Analysis of Faults Leading to Harms
ConclusionWe defined a medical device fault as an unintended failure in the design, manufacture, or use of a medical device that leads to, or has the potential to lead to, harm to the patient, and an adverse effect of a medical device as an unintended and appreciably harmful effect, caused by a medical device, which demonstrates a hazard of the device and may warrant preventive measures, or a change in the mode of use, or withdrawal of the device. Most faults that generate warnings arise from problems at the design stage, some arise at the manufacturing stage, and a few in usage. Careful assessment of the design of safety-...
Source: Drug Safety - November 4, 2019 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drug Safety)
Source: Drug Safety - November 3, 2019 Category: Drugs & Pharmacology Source Type: research

Development and First Use of the Patient ’s Qualitative Assessment of Treatment (PQAT) Questionnaire in Type 2 Diabetes Mellitus to Explore Individualised Benefit–Harm of Drugs Received During Clinical Studies
ConclusionsThe PQAT is a unique patient-reported outcome tool designed to aid understanding patients ’ real experience of benefits and disadvantages of a treatment. It combines the richness of qualitative data with quantitative data—information valuable for various stakeholders to make well-informed treatment decisions.Trial RegistrationClinicalTrials.gov identifier: NCT02973321. (Source: Drug Safety)
Source: Drug Safety - November 1, 2019 Category: Drugs & Pharmacology Source Type: research

Exposure to Infliximab During Pregnancy: Post-Marketing Experience
ConclusionsThe observed prevalence of adverse pregnancy and infant outcomes including congenital anomalies following exposure to IFX did not exceed estimates reported for the general population and no unexpected patterns were observed. (Source: Drug Safety)
Source: Drug Safety - October 31, 2019 Category: Drugs & Pharmacology Source Type: research

New Discoveries and Updates on Cutaneous Adverse Drug Reactions Presented at the 24th World Congress of Dermatology, Milan, Italy, 2019
(Source: Drug Safety)
Source: Drug Safety - October 30, 2019 Category: Drugs & Pharmacology Source Type: research

Benefit-Risk Assessment of Alogliptin for the Treatment of Type 2 Diabetes Mellitus
AbstractThe dipeptidyl peptidase-4 inhibitor (DPP-4i) alogliptin is an oral, antidiabetic treatment that is approved in many countries to treat patients with type 2 diabetes mellitus (T2DM), including the USA, Europe, and Japan. Alogliptin is efficacious both as monotherapy and as add-on/combination therapy with other commonly prescribed T2DM treatments, such as metformin and pioglitazone. Overall, alogliptin is well-tolerated in patients with T2DM, including older patients, those with renal and/or hepatic impairment, and those at high risk of cardiovascular events. There is a low risk of hypoglycemia, weight gain, acute p...
Source: Drug Safety - October 24, 2019 Category: Drugs & Pharmacology Source Type: research

Complementing Observational Signals with Literature-Derived Distributed Representations for Post-Marketing Drug Surveillance
ConclusionsResults from this study support the hypothesis that knowledge extracted from the literature can enhance the performance of SRS-based methods (and vice versa). Across reference sets, using literature and SRS information together performed better than using either source alone, providing strong support for the complementary nature of these approaches to post-marketing drug surveillance. (Source: Drug Safety)
Source: Drug Safety - October 22, 2019 Category: Drugs & Pharmacology Source Type: research

Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy
(Source: Drug Safety)
Source: Drug Safety - October 21, 2019 Category: Drugs & Pharmacology Source Type: research

Occurrences and Outcomes of Immune Checkpoint Inhibitors-Induced Vitiligo in Cancer Patients: A Retrospective Cohort Study
ConclusionsThis study provided an overall picture of ICI-induced vitiligo in daily medical practice on a large number of pharmacovigilance observations of case patients. Among the observations of ICI-induced vitiligo, the diagnosed cancer was melanoma for almost all patients. Most patients in the study experienced other associated adverse drug reactions (ADRs), such as colitis, pruritus, hypothyroidism, hyperthyroidism, thyroiditis, pancreatitis, and gastritis. Furthermore, our data suggest that the resolution of pembrolizumab- or nivolumab-induced vitiligo could be a marker of disease progression. Future studies evaluatin...
Source: Drug Safety - October 18, 2019 Category: Drugs & Pharmacology Source Type: research

Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)
ConclusionThis study found 14 classes of antibiotics having significant reporting associations with AKI. Among the antibiotics evaluated in this study, colistin had the highest AKI ROR and moxifloxacin had the lowest. (Source: Drug Safety)
Source: Drug Safety - October 17, 2019 Category: Drugs & Pharmacology Source Type: research

Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union
ConclusionsMedication error safety concerns were listed for almost a quarter of centrally authorised products approved during the study period. Further research is needed to evaluate the effectiveness and continued need for additional risk minimisation measures for medication errors. (Source: Drug Safety)
Source: Drug Safety - October 15, 2019 Category: Drugs & Pharmacology Source Type: research

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports
ConclusionsThe majority of signals regarding asthma therapy in children were already known, but we also identified new signals. We showed that signals can be masked if age stratification is not conducted. Further exploration is needed to investigate the risk and causality of the newly found signals. (Source: Drug Safety)
Source: Drug Safety - October 14, 2019 Category: Drugs & Pharmacology Source Type: research

Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination
ConclusionsThe results of this study indicate that a neural network approach can provide an accurate and scalable solution for potentially augmenting pharmacovigilance practitioner determination of adverse event seriousness in spontaneous, solicited, and medical literature reports. (Source: Drug Safety)
Source: Drug Safety - October 10, 2019 Category: Drugs & Pharmacology Source Type: research

Psoriasis After Exposure to Angiotensin-Converting Enzyme Inhibitors: French Pharmacovigilance Data and Review of the Literature
AbstractIntroductionAngiotensin-converting enzyme inhibitors (ACEIs) can induce or aggravate psoriasis. This risk is not specified in the Summary of Product Characteristics (SmPC) of some drugs of this class, such as captopril or enalapril. We aimed to investigate the association between psoriasis and ACEI exposure.MethodsWe analyzed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD) from 1985 to 31 December 2018. The association between psoriasis and ACEI exposure was assessed using the case/non-case method. We also reviewed literature reports.ResultsOne hundred reports of psoriasis afte...
Source: Drug Safety - October 8, 2019 Category: Drugs & Pharmacology Source Type: research

Adverse Events Associated with Cumulative Corticosteroid Use in Patients with Castration-Resistant Prostate Cancer: An Administrative Claims Analysis
This study evaluated the impact of cumulative corticosteroid exposure on the risk of developing specific adverse events in men with CRPC.MethodsData were obtained from administrative claims databases. Adult chemotherapy-na ïve men who initiated CRPC treatment following surgical or medical castration were selected. Patients were grouped into four cohorts based on cumulative corticosteroid dose: no exposure, low exposure (  2.0 g). Time to each adverse event was assessed using Kaplan–Meier analyses and time-dependent Cox proportional hazard models, adjusting for baseline characteristics.ResultsOverall,...
Source: Drug Safety - October 4, 2019 Category: Drugs & Pharmacology Source Type: research

Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures
ConclusionsFuture research is needed to investigate whether the wide variability in reporting rates for severe HSRs associated with these intravenous iron products are due to potential differences in the safety profiles of these substances. (Source: Drug Safety)
Source: Drug Safety - October 2, 2019 Category: Drugs & Pharmacology Source Type: research

Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports
ConclusionAnalysis of Japanese adverse event reporting patterns in a global context has revealed key features that may reflect possible  pharmaco-ethnic vulnerabilities in the Japanese, as well as differences in adverse event reporting and clinical practice. This knowledge is essential in the global collaboration of signal detection afforded by the WHO Programme for International Drug Monitoring. (Source: Drug Safety)
Source: Drug Safety - September 25, 2019 Category: Drugs & Pharmacology Source Type: research

Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy
ConclusionAntipsychotic safety warnings were followed by a reduction in stroke incidence among older antipsychotic users in the UK, but not Italy. (Source: Drug Safety)
Source: Drug Safety - September 24, 2019 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Ravi Jandhyala’s Comment on “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
(Source: Drug Safety)
Source: Drug Safety - September 23, 2019 Category: Drugs & Pharmacology Source Type: research

Comment on: “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
(Source: Drug Safety)
Source: Drug Safety - September 23, 2019 Category: Drugs & Pharmacology Source Type: research

Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews
AbstractDirect oral anticoagulants are now recommended by major guidelines as first-choice agents for both stroke prevention in non-valvular atrial fibrillation and treatment/prevention of venous thromboembolism in non-cancer patients. Although there are no published head-to-head trials comparing different direct oral anticoagulants, a growing body of evidence from indirect comparisons and observational studies is suggesting that each direct oral anticoagulant may have a specific risk profile. This review aims to (1) synthesize and critically assess the latest evidence in comparative effectiveness and safety research in th...
Source: Drug Safety - September 23, 2019 Category: Drugs & Pharmacology Source Type: research

19th ISoP Annual Meeting “New Opportunities for New Generations” Bogotá, Colombia, 26–29 October, 2019
(Source: Drug Safety)
Source: Drug Safety - September 11, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Patient Registries: An Underused Resource for Medicines Evaluation
The fourth sentence under the heading “1.1 Use of Patient Registries for Supporting Regulatory Assessments” in “1 Introduction” section should read as below. (Source: Drug Safety)
Source: Drug Safety - September 4, 2019 Category: Drugs & Pharmacology Source Type: research

Transparent Reporting on Research Using Unstructured Electronic Health Record Data to Generate ‘Real World’ Evidence of Comparative Effectiveness and Safety
AbstractResearch that makes secondary use of administrative and clinical healthcare databases is increasingly influential for regulatory, reimbursement, and other healthcare decision-making. Consequently, there are numerous guidance documents on reporting for studies that use ‘real-world’ data captured in administrative claims and electronic health record (EHR) databases. These guidance documents are intended to improve transparency, reproducibility, and the ability to evaluate validity and relevance of design and analysis decisions. However, existing guidance does n ot differentiate between structured and unst...
Source: Drug Safety - August 25, 2019 Category: Drugs & Pharmacology Source Type: research