Causality Assessment of Adverse Drug ReactionClinosolIndia
Causality assessment of adverse drug reactions (ADR) is the process of determining the likelihood or probability that a drug is responsible for causing an observed adverse event. It involves evaluating the relationship between the drug exposure and the occurrence of the adverse event based on available evidence, such as clinical data, patient characteristics, temporal association, and alternative explanations. Causality assessment is an essential component of pharmacovigilance and drug safety monitoring. Here are some commonly used methods and scales for causality assessment:
Naranjo Algorithm:
The Naranjo algorithm is a widely used causality assessment tool. It assigns a numerical score based on specific questions related to the temporal relationship, alternative causes, dechallenge/rechallenge, and previous knowledge of the drug-event association. The total score classifies the causality as definite, probable, possible, or doubtful.
World Health Organization-Uppsala Monitoring Centre (WHO-UMC) Scale:
The WHO-UMC scale is a standardized method for assessing causality in ADRs. It consists of a set of criteria that consider factors such as the time to onset of the event, the response to dechallenge/rechallenge, alternative causes, and the presence of supporting information. Causality is categorized as certain, probable/likely, possible, unlikely, or unclassified.
Bradford Hill Criteria:
The Bradford Hill criteria are a set of nine factors used to assess causality in various fields, including pharmacovigilance. These criteria include strength of association, consistency, specificity, temporality, biological plausibility, coherence, experimental evidence, analogy, and dose-response relationship. These factors are considered collectively to determine the likelihood of a causal relationship.
CIOMS (Council for International Organizations of Medical Sciences) Scale:
The CIOMS scale provides a structured approach to assessing causality by considering factors such as the temporal relationship, the presence of alternative causes, drug dechallenge/rechallenge, and the consistency of the event with the drug's known pharmacology.
Causality Assessment of Adverse Drug ReactionClinosolIndia
Causality assessment of adverse drug reactions (ADR) is the process of determining the likelihood or probability that a drug is responsible for causing an observed adverse event. It involves evaluating the relationship between the drug exposure and the occurrence of the adverse event based on available evidence, such as clinical data, patient characteristics, temporal association, and alternative explanations. Causality assessment is an essential component of pharmacovigilance and drug safety monitoring. Here are some commonly used methods and scales for causality assessment:
Naranjo Algorithm:
The Naranjo algorithm is a widely used causality assessment tool. It assigns a numerical score based on specific questions related to the temporal relationship, alternative causes, dechallenge/rechallenge, and previous knowledge of the drug-event association. The total score classifies the causality as definite, probable, possible, or doubtful.
World Health Organization-Uppsala Monitoring Centre (WHO-UMC) Scale:
The WHO-UMC scale is a standardized method for assessing causality in ADRs. It consists of a set of criteria that consider factors such as the time to onset of the event, the response to dechallenge/rechallenge, alternative causes, and the presence of supporting information. Causality is categorized as certain, probable/likely, possible, unlikely, or unclassified.
Bradford Hill Criteria:
The Bradford Hill criteria are a set of nine factors used to assess causality in various fields, including pharmacovigilance. These criteria include strength of association, consistency, specificity, temporality, biological plausibility, coherence, experimental evidence, analogy, and dose-response relationship. These factors are considered collectively to determine the likelihood of a causal relationship.
CIOMS (Council for International Organizations of Medical Sciences) Scale:
The CIOMS scale provides a structured approach to assessing causality by considering factors such as the temporal relationship, the presence of alternative causes, drug dechallenge/rechallenge, and the consistency of the event with the drug's known pharmacology.
This gives you a basic role pharmacovigilance and how it works before and after drug approval .It totally work for human needs.And what are governing bodies for pharmacovigilance and how to write Adverse Drug Reaction (ADR) Reporting Procedure.
Understanding Contracts in the Clinical Research ProcessMichael Swit
Presentation on key aspects of clinical trial agreements, with an emphasis on clauses impacting indemnification, confidentiality, material transfers, record retention, ownership of data,
This powerpoint presentation will help to know the introduction of Pre Clinical Trials.Hope you understand well.If you need more notes refer some pharma and Biotechnology books.
Clinical research is a systematic investigation that involves the study of human participants to evaluate the safety, efficacy, and effectiveness of medical treatments, drugs, devices, and interventions. The primary goal of clinical research is to generate robust and reliable evidence to inform healthcare decisions, improve patient care, and advance medical knowledge. It encompasses a wide range of activities and studies, including clinical trials, observational studies, and other research methodologies
Essential Documents For the Conduct of Clinical TrialClinosolIndia
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Signal Detection in Pharmacovigilance: Methods and AlgorithmsClinosolIndia
Signal detection in pharmacovigilance involves the identification of potential safety signals or unexpected patterns of adverse events that may indicate a previously unrecognized safety concern associated with a medication. Various methods and algorithms are employed to analyze large volumes of pharmacovigilance data and highlight signals that warrant further investigation. Here are some common methods and algorithms used for signal detection in pharmacovigilance
Toxicological Approach to Drug DiscoverySuhas Reddy C
For better understanding of students. This will give you a detailed explanation of Toxicological approach. Contact me through comment section if you need any assistance in understating
This gives you a basic role pharmacovigilance and how it works before and after drug approval .It totally work for human needs.And what are governing bodies for pharmacovigilance and how to write Adverse Drug Reaction (ADR) Reporting Procedure.
Understanding Contracts in the Clinical Research ProcessMichael Swit
Presentation on key aspects of clinical trial agreements, with an emphasis on clauses impacting indemnification, confidentiality, material transfers, record retention, ownership of data,
This powerpoint presentation will help to know the introduction of Pre Clinical Trials.Hope you understand well.If you need more notes refer some pharma and Biotechnology books.
Clinical research is a systematic investigation that involves the study of human participants to evaluate the safety, efficacy, and effectiveness of medical treatments, drugs, devices, and interventions. The primary goal of clinical research is to generate robust and reliable evidence to inform healthcare decisions, improve patient care, and advance medical knowledge. It encompasses a wide range of activities and studies, including clinical trials, observational studies, and other research methodologies
Essential Documents For the Conduct of Clinical TrialClinosolIndia
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Signal Detection in Pharmacovigilance: Methods and AlgorithmsClinosolIndia
Signal detection in pharmacovigilance involves the identification of potential safety signals or unexpected patterns of adverse events that may indicate a previously unrecognized safety concern associated with a medication. Various methods and algorithms are employed to analyze large volumes of pharmacovigilance data and highlight signals that warrant further investigation. Here are some common methods and algorithms used for signal detection in pharmacovigilance
Toxicological Approach to Drug DiscoverySuhas Reddy C
For better understanding of students. This will give you a detailed explanation of Toxicological approach. Contact me through comment section if you need any assistance in understating
Between the time that the police make an arrestand a case is event.docxjasoninnes20
Between the time that the police make an arrestand a case is eventually resolved at sentencing, traditional prosecutions involve several steps withpsychological implications. One feature of traditionalprosecutions with obvious psychological overtones isa trial. The grand finale in our adversary system ofjustice—the trial—is a public battle waged by twocombatants (prosecution versus defense in a criminaltrial, plaintiff versus defendant in a civil trial), eachfighting for a favorable outcome. Trials can befiercely contested; prosecutors desire convictions,criminal defendants seek their freedom throughacquittals, civil plaintiffs want compensation forwrongs they have suffered, and civil defendants hopeto be absolved of wrongdoing and not required to paydamages. Psychological issues abound.Although the trial may be the most visible anddramatic ritual in our system, many other factors playlarger—often decisive—roles in determining caseoutcomes. For example, in the weeks and months following arrest, many criminal cases are simplydismissed for lack of evidence or other difficulties thatprosecutors perceive in the case. Of some 49,000defendants charged with a felony from 1990 to 2002in the 75 most populous counties in the United States,24% had their cases dismissed prior to trial (Cohen &Reaves, 2006).For the vast majority of people charged withcrimes and not fortunate enough to have the chargesdropped,plea bargains, not trials, resolve their cases.Plea bargaining, described in more detail later in thechapter, is a process in which a defendant agrees toplead guilty in exchange for some concession fromthe prosecutor. Such concessions typically involve areduction in the type of charge, the number ofcharges, or the recommended sentence. By pleadingguilty, defendants give up their right to a trial,allowing attorneys and judges to move on to othercases. The vast majority of civil cases are also resolvedwithout a formal trial in a process termedsettlementnegotiation, described in more detail in this chapter.If most cases are settled without a trial, why is oursociety (including psychologists who work in the legalarena) so fascinated by trials and trial procedures?Without a doubt, there are theatrical aspects to manytrials, especially those featured in news media, films,and novels. Trials grab our attention because theyvividly portray the raw emotions of sad, distraught,and angry people. Interest in trials is also related totheir very public nature; most trials are conducted inopen court for all to see. Some are televised or evenavailable for online viewing.In contrast, negotiations about plea bargains andsettlements are largely hidden from public view.Prosecutors offer concessions to defense attorneysover the phone or in courthouse hallways. Defenseattorneys convey these offers to their clients in officesor jail cells. Settlement negotiations in civil cases arealso conducted in private. In fact, the eventualsettlements in civil ca ...
Between the time that the police make an arrestand a case is event.docxrichardnorman90310
Between the time that the police make an arrestand a case is eventually resolved at sentencing, traditional prosecutions involve several steps withpsychological implications. One feature of traditionalprosecutions with obvious psychological overtones isa trial. The grand finale in our adversary system ofjustice—the trial—is a public battle waged by twocombatants (prosecution versus defense in a criminaltrial, plaintiff versus defendant in a civil trial), eachfighting for a favorable outcome. Trials can befiercely contested; prosecutors desire convictions,criminal defendants seek their freedom throughacquittals, civil plaintiffs want compensation forwrongs they have suffered, and civil defendants hopeto be absolved of wrongdoing and not required to paydamages. Psychological issues abound.Although the trial may be the most visible anddramatic ritual in our system, many other factors playlarger—often decisive—roles in determining caseoutcomes. For example, in the weeks and months following arrest, many criminal cases are simplydismissed for lack of evidence or other difficulties thatprosecutors perceive in the case. Of some 49,000defendants charged with a felony from 1990 to 2002in the 75 most populous counties in the United States,24% had their cases dismissed prior to trial (Cohen &Reaves, 2006).For the vast majority of people charged withcrimes and not fortunate enough to have the chargesdropped,plea bargains, not trials, resolve their cases.Plea bargaining, described in more detail later in thechapter, is a process in which a defendant agrees toplead guilty in exchange for some concession fromthe prosecutor. Such concessions typically involve areduction in the type of charge, the number ofcharges, or the recommended sentence. By pleadingguilty, defendants give up their right to a trial,allowing attorneys and judges to move on to othercases. The vast majority of civil cases are also resolvedwithout a formal trial in a process termedsettlementnegotiation, described in more detail in this chapter.If most cases are settled without a trial, why is oursociety (including psychologists who work in the legalarena) so fascinated by trials and trial procedures?Without a doubt, there are theatrical aspects to manytrials, especially those featured in news media, films,and novels. Trials grab our attention because theyvividly portray the raw emotions of sad, distraught,and angry people. Interest in trials is also related totheir very public nature; most trials are conducted inopen court for all to see. Some are televised or evenavailable for online viewing.In contrast, negotiations about plea bargains andsettlements are largely hidden from public view.Prosecutors offer concessions to defense attorneysover the phone or in courthouse hallways. Defenseattorneys convey these offers to their clients in officesor jail cells. Settlement negotiations in civil cases arealso conducted in private. In fact, the eventualsettlements in civil ca.
A complete review of Forensic Science and its various branches.Hamza Mohammad
This is a complete review of Forensic Science and its various branches and the various methodology and techniques used for forensic analysis of various evidences and examination of crime scene.
It is the beginning point for obtaining evidence which will be used by the crime scene investigator and the forensic expert
A thorough investigation of the crime scene must be completed
Crime scene is basically a scene of occurrence of crime. It is a place where a particular crime has been committed.
It is starting point for the investigator.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
7. Federal Crime Labs FBI: Federal Bureau of Investigation DEA: Drug Enforcement Agency ATF: Alcohol, Tobacco, and Firearms USPS: United States Postal Service U.S. Fish and Wildlife Service Department of Homeland Security Department of the Treasury
8.
9.
10.
11. Types of Law Constitutional law Statutory law Common law or case law Civil law Criminal law Equity law Administrative law
12. The Bill of Rights You are guaranteed: To be presumed innocent until proven guilty Not to be searched unreasonably Not to be arrested without probable cause Against unreasonable seizure of personal property Against self-incrimination To fair questioning by police To protection from physical harm throughout the justice process To an attorney To trial by jury To know any charges against oneself
13. More Bill of Rights To cross-examine prosecution witnesses To speak and present witnesses Not to be tried again for the same crime Against cruel and unusual punishment To due process To a speedy trial Against excessive bail Against excessive fines To be treated the same as others, regardless of race, gender, religious preference, country of origin, or other personal attributes
14.
15.
16.
17. Miranda Rights The following is a minimal Miranda warning: You have the right to remain silent. Anything you say can and will be used against you in a court of law. You have the right to speak to an attorney, and to have an attorney present during any questioning. If you cannot afford a lawyer, one will be provided for you at the government’s expense.
18.
19.
20. Federal Rules of Evidence In order for scientific evidence to be admitted in a court of law, it must be considered relevant evidence which includes: Probative: actually proves something Material: addresses an issue that is relevant to the particular crime
21. Admissibility of Evidence The Frye Standard From the 1923 case Frye v. United States Scientific evidence is allowed into the courtroom if it is generally accepted by the relevant scientific community. The Frye standard does not offer any guidance on reliability. The evidence is presented in the trial and the jury decides if it can be used.