Anatomy and physiology of the kidney.
AORN J. 68: 799-820Kidney Function.
Clinical Biochemistry of Domestic Animals. Fifth Edition. Academic Press,Acute kidney injury: definition, pathophysiology and clinical phenotypes.
Clin Biochem Rev. 37: 85-98Thomas ME Blaine C Dawnay A Devonald MA Ftouh S Laing C et al.The definition of acute kidney injury and its use in practice.
Kidney Int. 87: 62-73Duru M Meydan O Kaya M Gulmez SE.Need for causality assessment tool for drug-induced acute kidney injury.
Clin Ther. 41: 1894-1897Safety of Medicines. A guide to detecting and reporting adverse drug reactions.
World Health Organization, ()Post marketing surveillance of adverse drug reactions in general practice. I: search for new methods.
Br Med J. 282: 1131-1132Writings on Pharmacovigilance. Selected articles (1963-2003) by David J Finney.
The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring,Understanding adverse drug reactions: an overview.
Nurse Prescribing. : 12Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. L 348/74 (2010). [Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32010L0084&from=EN
The CIBA-GEIGY approach to causality.
Drug Inf J. 18: 315-318Lewis JH Larrey D Olsson R Lee WM Frison L Keisu M.Utility of the Roussel Uclaf Causality Assessment Method (RUCAM) to analyze the hepatic findings in a clinical trial program: evaluation of the direct thrombin inhibitor ximelagatran.
Int J Clin Pharmacol Ther. 46: 327-339Criteria of drug-induced liver disorders. Report of an international consensus meeting.
J Hepatol. 11: 272-276Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries.
J Clin Epidemiol. 46: 1323-1330Benichou C Danan G Flahault A.Causality assessment of adverse reactions to drugs—II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge.
J Clin Epidemiol. 46: 1331-1336Agbabiaka TB Savovic J Ernst E.Methods for causality assessment of adverse drug reactions: a systematic review.
Drug Safety. 31: 21-37Theophile H Arimone Y Miremont-Salame G Moore N Fourrier-Reglat A Haramburu F et al.Comparison of three methods (consensual expert judgement, algorithmic and probabilistic approaches) of causality assessment of adverse drug reactions: an assessment using reports made to a French pharmacovigilance centre.
Drug Safety. 33: 1045-1054The Swedish drug-event assessment methods. Special workshop—regulatory.
Drug Inf J. 18: 267-269Arimone Y Begaud B Miremont-Salame G Fourrier-Reglat A Molimard M Moore N et al.A new method for assessing drug causation provided agreement with experts' judgment.
J Clin Epidemiol. 59: 308-314Arimone Y Bidault I Dutertre JP Gerardin M Guy C Haramburu F et al.Updating the French method for the causality assessment of adverse drug reactions.
Therapie. 68: 69-76Miremont-Salame G Theophile H Haramburu F Begaud B.Causality assessment in pharmacovigilance: the French method and its successive updates.
Therapie. 71: 179-186Theophile H Dutertre JP Gerardin M Valnet-Rabier MB Bidault I Guy C et al.Validation and reproducibility of the updated French Causality Assessment Method: an evaluation by pharmacovigilance centres & pharmaceutical companies.
Therapie. 70: 465-476WHO, The Uppsala Monitoring Center. The use of the WHO-UMC system for standardised case causality assessment [Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf?ua=1.
The challenges of adverse drug reaction evaluation.
J Pharmacovigilance. 6Teaching monograph. Tissue reactions to drugs.
Am J Pathol. 82: 613-647Toward the operational identification of adverse drug reactions.
Clin Pharmacol Ther. 21: 247-254Dangoumau J Evreux JC Jouglard J.Method for determination of undesirable effects of drugs.
Therapie. 33: 373-381Begaud B Evreux JC Jouglard J Lagier GImputation of the unexpected or toxic effects of drugs. Actualization of the method used in France.
Therapie. 40: 111-118Hutchinson TA Leventhal JM Kramer MS Karch FE Lipman AG Feinstein AR.An algorithm for the operational assessment of adverse drug reactions. II. Demonstration of reproducibility and validity.
JAMA. 242: 633-638Kramer MS Leventhal JM Hutchinson TA Feinstein AR.An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use.
JAMA. 242: 623-632Leventhal JM Hutchinson TA Kramer MSFeinstein AR. An algorithm for the operational assessment of adverse drug reactions. III. Results of tests among clinicians.
JAMA. 242: 1991-1994Blanc S Leuenberger P Berger JP Brooke EM Schelling JL.Judgments of trained observers on adverse drug reactions.
Clin Pharmacol Ther. 25: 493-498An algorithm for the classification of untoward events in large scale clinical trials.
Agents Actions Suppl. 7: 318-322Naranjo CA Busto U Sellers EM Sandor P Ruiz I Roberts EA et al.A method for estimating the probability of adverse drug reactions.
Clin Pharmacol Ther. 30: 239-245Assessment of causality in industrial setting.
Drug Inf J. 18: 307-313Assessment of causality in industrial settings.
Drug Inf J. 18: 297-302Aspects of standardization as applied to the assessment of drug-event associations.
Drug Inf J. 18: 199-210Incomplete information as a limiting factor in causality assessment of adverse drug reactions and its practical consequences.
Drug Inf J. 20: 423-431Venulet J Ciucci A Berneker GC.Standardized assessment of drug-adverse reaction associations—rationale and experience.
Int J Clin Pharmacol Ther Toxicol. 18: 381-388Venulet J Ciucci AG Berneker GC.Updating of a method for causality assessment of adverse drug reactions.
Int J Clin Pharmacol Ther Toxicol. 24: 559-568Moore N Biour M Paux G Loupi E Begaud B Boismare F et al.Adverse drug reaction monitoring: doing it the French way.
Lancet. 2: 1056-1058Diagnosis and causality assessment of drug-induced hepatic injury.
()in: Dukes MNG Drug-induced hepatic injury. Elsevier, Amsterdam: 1-13Danan G Benichou C Begaud B Biour M Couzigou P Evreux JC et al.Criteria of imputation of acute hepatitis to a drug. Results of consensus meetings.
Gastroenterologie clinique et biologique. 11: 581-585Causality assessment of adverse drug reactions using decision support and informatics tools.
Pharmacoepidemiol Drug Saf. 1: 235-249Causality assessment of adverse events in clinical trials: I. How good is the investigator drug causality assessment?.
Drug Inf J. 27: 387-394Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis.
Hepatology. 26: 664-669A quantitative approach of using genetic algorithm in designing a probability scoring system of an adverse drug reaction assessment system.
Int J Med Inform. 77: 421-430Horn JR Hansten PD Chan LN.Proposal for a new tool to evaluate drug interaction cases.
Ann Pharmacother. 41: 674-680The Australian method of drug-event assessment. Special workshop—regulatory.
Drug Inf J. 18: 271-273Bayesian adverse reaction diagnostic instrument (BARDI). Dictionary of Pharmaceutical Medicine.
Springer, Vienna: 13-14Lane DA Kramer MS Hutchinson TA Jones JK Naranjo C.The causality of adverse drug reactions using a Bayesian approach.
Pharmaceut Med. 2: 265-283Lanctot KL Kwok MCO Naranjo CA.Computerized Bayesian evaluation of adverse events.
Drug Inf J. 29: 319-325Adverse drug reactions in the community health setting: approaches to recognizing, counseling, and reporting.
Fam Community Health. 5: 58-67The Food and Drug Administration algorithm. Special workshop—regulatory.
Drug Inf J. 18: 259-266Validity study of a new diagnostic scale for drug-induced liver injury in Japan—comparison with two previous scales.
Hepatol Res. 30: 148-154Gallagher RM Kirkham JJ Mason JR Bird KA Williamson PR Nunn AJ et al.Development and inter-rater reliability of the Liverpool adverse drug reaction causality assessment tool.
PloS One. 6: e28096Oosterhuis I Zweers P Rumke H Muller-Hansma A van Puijenbroek EP.A tailor-made approach for causality assessment for ADR reports on drugs and vaccines.
Pharmacoepidemiol Drug Saf. 28: 544-550Mascoloa A Scavonea C Sessaa M di Mauroa G Cimmarutaa D Orlandoc V et al.Can causality assessment fulfill the new European definition of adverse drug reaction? A review of methods used in spontaneous reporting.
Pharmacologic Res. 123: 122-129Stephens’ Detection and Evaluation of Adverse Drug Reactions Principles and Practice.
Sixth Edition. Wiley-Blackwell,The lymphocyte transformation test in the diagnosis of drug hypersensitivity.
Allergy. 59: 809-820Joh K Aizawa S Yamaguchi Y Inomata I Shibasaki T Sakai O et al.Drug-induced hypersensitivity nephritis: lymphocyte stimulation testing and renal biopsy in 10 cases.
Am J Nephrol. 10: 222-230Adverse drug reactions in special populations—the elderly.
Br J Clin Pharmacol. 80: 796-807Corsonello A Pedone C Corica F Mussi C Carbonin P Antonelli Incalzi R et al.Concealed renal insufficiency and adverse drug reactions in elderly hospitalized patients.
Arch Intern Med. 165: 790-795The 6R's of drug induced nephrotoxicity.
BMC Nephrol. 18: 124Chemical individuality: concept and outlook.
J Inherit Metab Dis. 31: 630-640Pharmacogenovigilance: a pharmacogenomics pharmacovigilance program.
Pharmacogenomics. 15: 845-856Pharmacogenovigilance—an idea whose time has come.
Curr Pharmacogenomics Pers Med. 8: 1-3Dictionary of Pharmacoepidemiology.
John Wiley & Sons, Ltd, Dieterle F Perentes E Cordier A Roth DR Verdes P Grenet O et al.Urinary clusterin, cystatin C, beta2-microglobulin and total protein as markers to detect drug-induced kidney injury.
Nature Biotechnol. 28: 463-469Da Y Akalya K Murali T Vathsala A Tan CS Low S et al.Serial quantification of urinary protein biomarkers to predict drug-induced acute kidney injury.
Curr Drug Metab. 20: 656-664Guo J Guan Q Liu X Wang H Gleave ME Nguan CY et al.Relationship of clusterin with renal inflammation and fibrosis after the recovery phase of ischemia-reperfusion injury.
BMC Nephrol. 17: 133Ann Clin Biochemistry. 39: 89-104Yamamoto T Noiri E Ono Y Doi K Negishi K Kamijo A et al.Renal L-type fatty acid–binding protein in acute ischemic injury.
J Am Soc Nephrol. 18: 2894-2902Noiri E Doi K Negishi K Tanaka T Hamasaki Y Fujita T et al.Urinary fatty acid-binding protein 1: an early predictive biomarker of kidney injury.
Am J Physiol Renal Physiol. 296: F669-F679Mehta RL Awdishu L Davenport A Murray PT Macedo E Cerda J et al.Phenotype standardization for drug-induced kidney disease.
Kidney Int. 88: 226-234Moledina DG Perazella MA.Treatment of drug-induced acute tubulointerstitial nephritis: the search for better evidence.
Clin J Am Soc Nephrol. 13: 1785-1787Kashani K Al-Khafaji A Ardiles T Artigas A Bagshaw SM Bell M et al.Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury.
Crit Care. 17: R25Guzzi LM Bergler T Binnall B Engelman DT Forni L Germain MJ et al.Clinical use of [TIMP-2]*[IGFBP7] biomarker testing to assess risk of acute kidney injury in critical care: guidance from an expert panel.
Crit Care. 23: 225Han WK Bailly V Abichandani R Thadhani R Bonventre JV.Kidney injury molecule-1 (KIM-1): a novel biomarker for human renal proximal tubule injury.
Kidney Int. 62: 237-244Vaidya VS Ferguson MA Bonventre JV.Biomarkers of acute kidney injury.
Annu Rev Pharmacol Toxicol. 48: 463-493Haase M Bellomo R Devarajan P Schlattmann P Haase-Fielitz A NGAL Meta-analysis Investigator GroupAccuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis.
Am J Kidney Dis. 54: 1012-1024Lumlertgul N Amprai M Tachaboon S Dinhuzen J Peerapornratana S Kerr SJ et al.Urine neutrophil gelatinase-associated lipocalin (NGAL) for prediction of persistent AKI and major adverse kidney events.
Sci Rep. 10: 8718Lin X Yuan J Zhao Y Zha Y.Urine interleukin-18 in prediction of acute kidney injury: a systemic review and meta-analysis.
J Nephrol. 28: 7-16Delanaye P Cavalier E Pottel H.Serum creatinine: not so simple!.
Nephron. 136: 302-308Guideline on good pharmacovigilance practices (GVP). Module VI—collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2), (2017). [Available from https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf.
Argyropoulos A Townley S Upton PM Dickinson S Pollard AS.Identifying on admission patients likely to develop acute kidney injury in hospital.
BMC Nephrol. 20: 56Roberts G Phillips D McCarthy R Bolusani H Mizen P Hassan M et al.Acute kidney injury risk assessment at the hospital front door: what is the best measure of risk?.
Clin Kidney J. 8: 673-680McMahon GM Zeng X Waikar SS.A risk prediction score for kidney failure or mortality in rhabdomyolysis.
JAMA Intern Med. 173: 1821-1828Tziakas D Chalikias G Stakos D Apostolakis S Adina T Kikas P et al.Development of an easily applicable risk score model for contrast-induced nephropathy prediction after percutaneous coronary intervention: a novel approach tailored to current practice.
Int J Cardiol. 163: 46-55Predicting contrast induced nephropathy in patients undergoing percutaneous coronary intervention.
J Thorac Dis. 11: 2672-2674Jeon N Staley B Henriksen C Lipori GP Winterstein AG.Development and validation of an automated algorithm for identifying patients at higher risk for drug-induced acute kidney injury.
Am J Health Syst Pharm. 76: 654-666Big data and pharmacovigilance: data mining for adverse drug events and interactions.
P T. 43: 340-351Oosterhuis I Taavola H Tregunno PM Mas P Gama S Newbould V et al.Characteristics, quality and contribution to signal detection of spontaneous reports of adverse drug reactions via the WEB-RADR mobile application: a descriptive cross-sectional study.
Drug Safety. 41: 969-978Schmider J Kumar K LaForest C Swankoski B Naim K Caubel PM.Innovation in pharmacovigilance: use of artificial intelligence in adverse event case processing.
Clin Pharmacol Ther. 105: 954-961
Comments (0)