The document discusses various methods used for causality assessment of adverse drug reactions (ADRs), including algorithms. It outlines several algorithms such as the Karch & Lasagna, Begaud, Jones, Kramer, Naranjo, WHO-UMC, Thai, CIOMS/RUCAM, and ALDEN algorithms. Each algorithm has advantages and limitations. While the Naranjo algorithm is simple and brief, its dependability and validity are not confirmed for all populations. The WHO-UMC criteria are intended as a convenient tool for individual case reports but have limitations. Specific algorithms like CIOMS/RUCAM and ALDEN are used for certain ADRs. The best algorithm depends on the type of
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
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Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Causality Assessment in PharmacovigilanceClinosolIndia
Causality assessment is the process of determining whether a particular drug or medical intervention is the cause of an adverse event or reaction that has occurred in a patient. The following are some key principles and factors that are considered in causality assessment:
Temporal relationship: The timing of the adverse event in relation to the drug or intervention is a key factor in causality assessment. If the adverse event occurs shortly after the drug is administered or the intervention is performed, this may suggest a causal relationship.
Biological plausibility: The biological mechanisms by which the drug or intervention could cause the adverse event should be considered. If there is a plausible biological mechanism for the adverse event, this may support a causal relationship.
Alternative explanations: Other factors that could have caused the adverse event, such as pre-existing medical conditions, should be considered and ruled out before attributing the event to the drug or intervention.
Dose-response relationship: If there is a clear dose-response relationship between the drug or intervention and the adverse event, this may suggest a causal relationship.
Rechallenge: If the adverse event reoccurs when the drug or intervention is readministered, this may provide further evidence for a causal relationship.
There are several methods for conducting causality assessment, including the Naranjo algorithm, the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and the Liverpool Causality Assessment Tool (LCAT). These methods use different criteria and scoring systems to evaluate the likelihood of a causal relationship between the drug or intervention and the adverse event.
Benefit-risk assessment is an integral part of FDA's regulatory review of marketing applications for new drugs and biologics. These assessments capture the Agency's evidence, uncertainties, and reasoning used to arrive at its final determination for specific regulatory decisions.
MedicReS Winter School 2017 Vienna - Importance of Selection of Outcomes - Ma...MedicReS
Importance of Selection of Outcomes and Covariates in Comparative Effectiveness of Cancer ...
International Conference Good Biostatistical and Publication Practice in Cancer Research with “Real Work Data”
February 13-14th, Vienna
Mariana Chavez Mac GregorMD, MSc.
Assistant Professor, Health Services Research Department
Breast Medical Oncology Department
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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5. A
Assessment
• Causality assessment
probability
an observed adverse event
• Adverse events with high causal association (probable
and certain) with the drug are likely to recur
• An important component of the evaluation of the
benefit/harm profiles of drugs
• Thus, providing information on this causal link may be
useful in preventing future recurrences.
The use of the WHO-UMC system for standardised case causality assessment.
[Last accessed on 2015 Feb 8]. Available from:
graphics/4409.pdf
6. Methods used for
Causality Assessment
- Taofikat B. Agbabiaka, J. Savovi´c and Edzard, E. Methods for causality assessment of
adverse drug reactions: A systematic review. Drug Safety 2008; 31 (1): 21-37
- Hutchinson TA, Dawid AP, Spiegelhalter DJ, et al. Computer- ized aids for probabilistic
assessment of drug safety: I. A spreadsheet program. Drug Inf J 1991; 25: 29-39
- Arimone Y, Miremont-Salamé G, Haramburu F, Molimard M, Moore N, Fourrier-
Réglat A, Bégaud B. Inter-expert agreement of seven criteria in causality assessment of
adverse drug reactions. Br J Clin Pharmacol. 2007c; 64(4):482–8.
7. Method Global Introspection Algorithms
Probabilistic or Bayesian
approaches
Details
Clinical judgment; an expert
panel considering all available
data relevant to a suspected
ADR
Sets of specific
questions with
associated scores for
calculating the
likelihood of a cause-
effect relationship
Probability for causality
calculated from prior
knowledge &
need the specific
findings in a case
Pros
• Most common approach:
major role in the
identification and rating of
potential ADRs
• More sensitivity
• More reliable and
reproducible
measurement (Least
inter- and intra-rater
contradiction)
• Simplicity
• Overcome the
numerous limitations
associated with expert
judgements &
algorithms The Bayesian
Adverse Reactions Diagnostic
Instrument (BARDI)
• Valid and internally
consistent assessment
Cons
• inter- and intra-rater
contradiction
• Subjectivity& Imprecision
• Poor reproducibility
because it is mainly based
on expert clinical
judgements
• No one universal
algorithm
• Scoring can be
arbitrary
• Responses to
questions can be
subjective
• Poor specificity
• Complex calculations
• Requires more time
and more expertise
9. Algorithms for causality evaluation tools
• Early 17s: Principle of disease to drugs in
individual patients
• 1981: International meeting in Morges, Switzerland
concluded 9 important points in causality
assessment
Meyboom RH
IR.Causal or casual? The role of causality assessment in
pharmacovigilance.
11. Algorithms
More than thirty algorithms of causality evaluation
tools were developed
• General algorithms :
UMC
• Specific algorithms :
for International Organizations of Medical
Sciences/Roussel Uclaf Causality Assessment
Method (CIOMS/RUCAM)
12. General algorithms
• Karch and Lasagna algorithm (1977) : Three tables
• Begaud algorithm (1977) -> French criteria : Three-stage
process
• Jones algorithm (1979) : Yes-No series
• Kramer (1979) : 56 questions
• Naranjo’s algorithm (1981) : 10 questions
• WHO-UMC : Grades of certainty (Certain, Probable/Likely,
Possible, Unlikely)
• Thai algorithm
13.
14.
15.
16. Begaud algorithm (1977) -> French
• Three-stage process
• Assessment of three chronological criteria
(challenge, dechallenge, and rechallenge)
• Assessment of clinical and biological findings
• Combination of chronological and
symptomatological assessments to obtain a 3-degree
global score (1: doubtful, 2: possible, 3: probable)
17. Jones algorithms
Jones JK. Adverse drug reactions in the community health
setting: approaches to recognizing, counseling, and reporting.
Clin Comm Health. 1982;5(2):58-
No score calculation
18. Naranjo’s algorithm
• Total score: Definite > 8; probable 5-8; possible 1-4; doubtful <0
• Modified Naranjo’s algorithm
Naranjo C.A., Busto U., Sellers E.M., Sandor P., I. Ruiz,
E.A., Roberts, et al.A method for estimating
the probability of adverse drug reactions.
Pharmacol. Ther., 30 (1981), pp. 239–245
24. Algorithm characteristics
Algorithms Advantage Limitation
Karch &
Lasagna
No specific advantage in comparison to
others
• Reliability & validity not well
established
Begaud More specific than Jones algorithm
• Consume more time than others
Jones
Shorter and quicker to complete &
detect the least ADR ?
• Cannot identified actual cause
Kramer More specific than others
• Clinicians can disagree on the weighted
values, make subjective judgments for
some questions
• Unexpected ADR may not score well
Naranjo
Simple & brief
Type A ADR
• Dependability and validity not
confirmed in children
• Drug interaction
WHO-UMC
Mainly planned as convenient tool
for the assessment of individual case
reports
• Non probabilistic method and creates
extensive unpredictability in evaluation
• Hard to remember
Thai Type B ADR • Less acceptance (Vs modified Naranjo’s)
25. • 120 patients from 4 groups were chosen at random:
• Proven hypersensitivity to b-lactams(n=30)
• Without proven hypersensitivity to b-lactams(n=30)
• Proven hypersensitivity to NSAIDs
• Without proven hypersensitivity to NSAIDs
29. Conclusion
• Jones algorithm compared favourably with the
Naranjo algorithm in scoring drug hypersensitivity
reactions, it is a simpler algorithm to use
• The Begaud algorithm
the Jones algorithm, may be more specific with
better predictive values.
30.
31. Khan, L.M., Al-Harthi, S.E., Osman, A.M.,
AbdulSattar, M.A., Ali, A.S., Dilemmas of the
causality assessment tools in the diagnosis of adverse
drug reactions, Saudi Pharmaceutical Journal (2015)
32. Evaluation terms
Definite
Highly
probable
Definite Definite Certain Certain
Probable Probable Probable Probable Probable Probable Probable
Possible Possible Possible Possible Possible Possible Possible
Conditional Doubful Remote Unlikely Doubful Unlikely Unlikely
Karch &
Lasagna
Begaud Jones Kramer Naranjo
WHO-
UMC
Thai
36. Evaluation of
• Points are summed and the total compared to this chart:
• 0 or lower: relationship with the drug excluded
• 1-2: unlikely
• 3-5: possible
• 6-8: probable
• >8: highly probable
37. Limitation of
• Complexity. Ambiguous instructions
• Mixed cases included into the cholestatic group
• Atypical time or
to onset
• Arbitrary risk factors: age ≥ 55y, alcohol, pregnant
• Unclear criteria for competing drug(s) Subjective
interpretation of the drug hepatotoxic
38.
39. • Among 187 enrollees,
complete agreement was reached for 50 (27%) with the expert
opinion process and for 34 (19%) with a five-category RUCAM
scale (P = 0.08), and the two methods demonstrated a modest
correlation with each other (Spearman's r = 0.42, P = 0.0001)
40. Conclusion
• The structured
produced higher agreement rates and likelihood
scores than RUCAM
there was still considerable interobserver variability
in both.
• Accordingly, a more objective, reliable, and
reproducible means of assessing DILI causality is
still needed.
41.
42.
43. • CIOMS/RUCAM scale had better interobserver
reliability (reproducibility) than the NARANJO
scale.
• In the assessment routines for signal detection at
pharmacovigilance centres, the CIOMS/RUCAM
scale is the preferred tool for caus- ality assessment
in hepatotoxicity
44. AL
• ALDEN scores were strongly correlated with those
of the EuroSCAR case-control analysis for drugs
associated with EN (r = 0.90, P < 0.0001)
Clin Pharmacol Ther. 2010 Jul;88(1):60-8. doi: 10.1038/clpt.2009.252. Epub 2010 Apr 7.
ALDEN, an algorithm for assessment of drug causality in Stevens-Johnson Syndrome and toxic epidermal
necrolysis: comparison with case-control analysis.
Sassolas B
Louet H.