The document discusses the role and responsibilities of an Institutional Review Board/Independent Ethics Committee (IRB/IEC). It states that an IRB/IEC reviews clinical trial protocols to ensure the ethical treatment of study participants and protection of their rights and well-being. The IRB/IEC is composed of at least five members with diverse qualifications and one member from a non-scientific discipline. It is responsible for approving, monitoring and reviewing research involving humans. The IRB/IEC conducts initial and annual reviews of trial procedures and documentation. All records are maintained for at least three years.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
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
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
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
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
IRB/IEC serves as an independent body that reviews, evaluate, approves and decides on the scientific and ethical aspects of the clinical trial protocol as well as the benefits and risks to the study participants.
Main purpose of IRB/IEC is to protect the rights, safety and well being of the subjects who participate in a trial.
National research act passed by congress on July 12, 1974, mandated establishment of IRB/IEC.
Act provide national commission for protection of human subjects of biomedical and behavioral research and lead to publication of The Belmont Report in 1979.
The amended regulation on July 27, 1981.
Submission of NDA’S approval of IRB is necessary.
Institutional review Board (IRB) by Mr. Rushikesh Shinde.pptxRushikeshShinde74
Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
IRB/IEC serves as an independent body that reviews, evaluate, approves and decides on the scientific and ethical aspects of the clinical trial protocol as well as the benefits and risks to the study participants.
Main purpose of IRB/IEC is to protect the rights, safety and well being of the subjects who participate in a trial.
National research act passed by congress on July 12, 1974, mandated establishment of IRB/IEC.
Act provide national commission for protection of human subjects of biomedical and behavioral research and lead to publication of The Belmont Report in 1979.
The amended regulation on July 27, 1981.
Submission of NDA’S approval of IRB is necessary.
Institutional review Board (IRB) by Mr. Rushikesh Shinde.pptxRushikeshShinde74
Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.
Role of IRB and IEC in Safeguarding the Subjects in Clinical TrialsClinosolIndia
In clinical research, the protection of human subjects is of utmost importance to ensure ethical conduct and adherence to regulatory standards. Two key entities responsible for safeguarding the rights, safety, and well-being of subjects in clinical trials are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). They play essential roles in the oversight and ethical review of clinical research protocols. Here's a breakdown of their roles in safeguarding clinical trial subjects:
Institutional Review Boards (IRBs):
Ethical Review: IRBs are responsible for conducting an ethical review of research protocols to ensure that the study is designed and conducted in an ethical and morally sound manner. They assess the study's potential risks, benefits, and the protection of subjects' rights.
Informed Consent: IRBs review and approve the informed consent process to ensure that subjects are provided with comprehensive and understandable information about the study, including its purpose, procedures, risks, and benefits. They assess the adequacy of the informed consent document.
Risk-Benefit Assessment: IRBs assess the risks and potential benefits of the research to determine whether they are balanced and reasonable. They weigh the scientific and societal value of the research against the risks posed to subjects.
Subject Recruitment and Selection: IRBs review the methods and materials used for subject recruitment and selection to ensure that they are non-coercive, fair, and do not discriminate against vulnerable populations.
Continual Oversight: IRBs provide ongoing oversight of approved studies. They monitor the progress of research, ensuring that it adheres to the approved protocol and that any deviations or adverse events are appropriately reported and addressed.
Conflict of Interest: IRBs evaluate potential conflicts of interest among researchers, ensuring that financial or non-financial interests do not compromise the rights or safety of research subjects.
Privacy and Confidentiality: IRBs assess how subjects' privacy and confidentiality will be protected, particularly in studies involving sensitive information or data.
Emergency Use of Investigational Products: In cases of emergency use of investigational products, IRBs may provide authorization, ensuring that the use is in the best interest of the subject.
An overview of Institutional Review Board or Independent Ethics CommitteeClinosolIndia
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is a critical component of the ethical oversight process in clinical research involving human participants. Its primary purpose is to protect the rights, welfare, and well-being of study participants by ensuring that research studies are conducted ethically, following established ethical principles and regulatory guidelines. IRBs/IECs play a crucial role in reviewing, approving, and monitoring research protocols to ensure they meet ethical and regulatory standards.
An overview of Institutional Review Board or Independent Ethics CommitteeClinosolIndia
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) plays a crucial role in ensuring the ethical conduct of research involving human subjects. These boards are typically established by organizations, institutions, or agencies that conduct or sponsor research activities. The primary purpose of an IRB/IEC is to protect the rights, well-being, and confidentiality of human research participants.
Software Used In Formulation Design Process- Minor Project [Bachelor].pdfRAHUL PAL
In the field of formulations, various software tools are commonly used to streamline and optimize the development process. One such software is formulation management software, which helps in creating and managing formulations by allowing scientists to input ingredient quantities, calculate costs, and analyze ingredient interactions. Additionally, simulation software like computational fluid dynamics (CFD) programs are utilized to model and predict how formulations will behave under different conditions, aiding in the design of efficient manufacturing processes. Furthermore, statistical analysis software plays a crucial role in analyzing experimental data and optimizing formulations based on statistical models, ensuring that the final product meets desired specifications. Overall, these software tools enhance productivity, accuracy, and efficiency in the formulation development workflow.
Major Project (B. Pharm) OPIUM POPPY PROJECT.pdfRAHUL PAL
Opium cultivation, an ancient practice rooted in regions like the Golden Triangle and Golden Crescent, involves a meticulous process blending nature and human intervention. Picture a serene landscape with gently rolling hills blanketed in lush greenery. Amidst this verdant tapestry stand tall, slender opium poppy plants, their delicate petals shimmering in hues of pink and white. These plants exude an air of mystique, their bulbous seed pods containing the coveted opium latex. Skilled farmers nurture these plants with utmost care, tending to their needs for water, nutrients, and protection from pests. The cultivation cycle begins with sowing the poppy seeds during specific seasons conducive to their growth. As the plants mature, they blossom into exquisite flowers, each harboring the potential for opium production. The farmers deftly slit the seed pods at just the right moment, allowing the milky sap to seep out and gradually solidify into opium. This labor-intensive process demands precision and patience, as any misstep can impact the potency and quality of the opium yield. Despite its allure, opium cultivation is not without controversy and challenges. Legal restrictions, environmental concerns, and the socioeconomic impacts on communities underscore the complex nature of this age-old practice. However, for those entrenched in the art of opium cultivation, it remains a delicate dance between tradition, livelihood, and the ever-evolving dynamics of global demand and supply.
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Niosome An Non-Ionic Surfactant Vesicles.pptxRAHUL PAL
Niosomes are novel drug delivery systems that have garnered significant interest in the pharmaceutical field. They are essentially vesicles composed of non-ionic surfactants and cholesterol, forming a bilayer structure similar to liposomes. However, unlike liposomes, which are composed of phospholipids, niosomes are formed by self-assembly of non-ionic surfactants in aqueous media. This unique composition offers several advantages such as improved drug solubility, stability, and biocompatibility.
The introduction of niosomes as drug carriers has revolutionized the field of drug delivery due to their ability to encapsulate both hydrophilic and hydrophobic drugs. This versatility allows for targeted and controlled release of therapeutics, enhancing their efficacy while minimizing side effects.
Moreover, the surface of niosomes can be modified to achieve specific targeting of drugs to desired sites within the body, thus enhancing therapeutic outcomes and reducing systemic toxicity.
Overall, niosomes hold great promise in the pharmaceutical industry and continue to be a subject of intense research for their potential applications in various fields including cancer therapy, gene delivery, and vaccine development.
𝐎𝐫𝐚𝐥 𝐏𝐚𝐩𝐞𝐫 𝐏𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 (𝐈𝐑𝐓𝐄𝐂 𝟐.𝟎-𝟐𝟎𝟐𝟒); The Curre...RAHUL PAL
Targeted drug delivery systems are employed to administer pharmaceutical medication,
facilitating the precise delivery of drugs to specific diseased areas. Several drug delivery
systems utilise carriers such as antibodies, transdermal patches, biodegradable polymers,
nanoparticles (NPs), liposomes, niosomes, and microspheres. Niosomes, on the other hand,
represent a promising and innovative category of vesicular systems. Niosomes are vesicles
formed by hydrating a combination of nonionic surfactants and cholesterol. These non-ionic
surfactant vesicles serve as carriers for both amphiphilic and lipophilic drugs. In the drug
delivery system using niosomes, the medication is enclosed within a vesicle. Niosomes in
tuberculosis (TB) possess biodegradable and biocompatible properties, are non-immunogenic,
and demonstrate versatility in their structural composition. It’s a serious and potentially deadly
infectious disease caused by a bacteria called Mycobacterium tuberculosis. In the recent
update, WHO still estimates 9.9 million new TB cases in 2022 at the latest. Involvement of
niosomes improves the treatment of TB with much more advanced technology and an advanced
drug nanocarrier with better treatment. The main highlights of this review paper are to
summarise the structure, compositions, preparation methods, and ICH stability guidelines for
the formulation of niosomes and their applications in TB with their several stages of treatment
by niosomal formulations.
Introduction: This study explores the use of Response Surface Methodology (RSM), a statistical optimization technique, to optimize the SR properties of prochlorperazine maleate (PCM) matrix tablets. PCM is a phenothiazine derivative used for treating schizophrenia, nausea, and vomiting. Sustained-release formulations offer extended drug delivery, potentially improving patient compliance and reducing side effects. RSM helps identify optimal combinations of critical formulation factors influencing drug release, such as polymer type and concentration, filler type, and drug/polymer ratio. The study likely involves designing experiments based on chosen RSM designs (e.g., Box-Behnken) with varying factor levels. Formulate SR tablets with different factor combinations. Evaluating the drug release profiles of each tablet formulation. Analyzing data using RSM software to build mathematical models relating factors to drug release and identifying optimal factor combinations that maximize desired release characteristics.
Objective: The ongoing research purpose to improve the advancement of a sustained release tablet containing Phenothiazine derivative PCM loaded matrix. This is achieved by utilizing DoE as a computational method to statistically validate the formulation.
THE CURRENT STATUS IN MUCOSAL DRUG DELIVERY SYSTEM (MDDS) AND FUTURE PROSPECT...RAHUL PAL
This systematic review aims to provide a comprehensive overview of the current status of
mucosal drug delivery systems (MDDS) and explore their future prospects in drug delivery.
MDDS have gained significant attention in recent years due to their potential to enhance drug
absorption, improve therapeutic efficacy, and minimize systemic side effects. This review
critically evaluates the existing literature on MDDS, including various mucosal routes such as
oral, nasal, ocular, pulmonary, and vaginal delivery. Additionally, it discusses the challenges
associated with MDDS, such as formulation development, stability, and regulatory
considerations. Furthermore, this review highlights emerging technologies and innovative
strategies that hold promise for the future of MDDS. Overall, this systematic review provides
valuable insights into the current landscape of MDDS and offers recommendations for future
research and development in this field.
Design of Experiments (DoE) manipulation in the formulation and optimization ...RAHUL PAL
Introduction: In India, the regulatory body for catechu is the Food Safety and Standards Authority of
India (FSSAI). The FSSAI is responsible for regulating the manufacture, sale, and distribution of food in
India, including catechu. The FSSAI has set standards for the purity and quality of catechu, and it also
monitors the market for adulterated catechu. The FDA (The Food and Drug Administration) is
responsible for regulating the safety and efficacy of drugs and dietary supplements in the United States
(US). The FDA has not approved catechu as a drug or dietary supplement, but it does regulate catechu as
a food additive. The FDA has set limits on the amount of catechu that can be added to food
Objective: The primary objective of this research was to involvement of design of experiments (DoE)
manipulation in the formulation and optimization of a traditional Ayurvedic medicine derived from dried
extract of Senegalia catechu enhanced through statistical analysis.
Methodology: The dried extract of Senegalia catechu was collected and identified at the botanical
herbarium garden. Subsequently, it underwent a drying process and was ground into a powder.
The Utilization of 32 Full Factorial Design (FFD) for Optimization of Linco...RAHUL PAL
Objectives: The ongoing research aims to enhance the development of LNH-loaded nanogel by
utilizing DoE as the computational method to statistically validate their formulation.
Methodology: In this research Chitosan used as a natural polymer and Poly (Ethylene glycol)
[PEG] as a penetration or permeation enhancer. The different nanogel of LNH were synthesized
using the Nanoprecipitation and Dispersion method, with variations in the drug-polymer ratio
(1/0.03, 1/0.08, 1/0.12). The process parameters were carefully optimizing for enhance the
efficiency of the synthesis. To achieve this, optimization studies were conducted using 3² FFD,
employing the Design Expert Software Trial version 10.0.7. The total of 13 runs were generated to
ensure comprehensive analysis and evaluation of the procedure. The selected independent
variables included the concentration of Chitosan (R1) and Carbopol 934 (R2). The dependent
variables, on the other hand, were particle size (P1), Polydispersity Index (P2), and % Drug release
(P3), chosen in that order. By employing this optimization technique, one can acquire valuable
information in a manner that is both efficient and cost-effective. This approach facilitates a deeper
comprehension of the relationship between controllable independent variables and the performance
and quality of the Nanogels being produced.
Determination of Partition coefficient of Known and Unknown drug.pdfRAHUL PAL
Partition coefficient, often denoted as P or P_oct, is a measure of how a solute distributes between two immiscible (unmixable) solvents. It is commonly used in chemistry, biochemistry, and pharmacology to understand the distribution of a compound between different phases, such as between a hydrophobic organic solvent and water. In experimental settings, the partition coefficient is determined by measuring the concentrations of the solute in each phase. The values obtained provide insights into the solute's behavior and can guide decisions in various scientific and industrial processes.
A pharmaceutical suspension is a heterogeneous system in which finely divided solid particles are dispersed in a liquid medium. Unlike solutions, where solutes are completely dissolved, suspensions involve particles that are only partially soluble or insoluble in the liquid. These suspensions are commonly used in the pharmaceutical industry to deliver medications that may be poorly soluble or unstable in their pure form. The solid particles, often in the form of powders or crystals, are dispersed throughout the liquid phase, creating a stable mixture through the use of suspending agents or stabilizers. These agents prevent the settling of particles, ensuring uniform distribution and ease of redispersion upon shaking before administration. Pharmaceutical suspensions offer advantages in terms of flexibility in dosing and formulation, enabling the delivery of therapeutic agents in various forms such as oral liquids, injectables, or topical preparations, enhancing patient compliance and therapeutic efficacy. The formulation and stability of pharmaceutical suspensions require careful consideration of factors such as particle size, density, and the choice of stabilizers to maintain a consistent and reliable product.
PHARMACEUTICAL SUPPOSITORIES & PESSARIES.pptRAHUL PAL
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
Partition Coefficient Determination (Pharmaceutics Practical).pptxRAHUL PAL
Partition coefficients are a fascinating and important concept in many fields, from chemistry and environmental science to medicine and pharmacology. They tell us about how a substance will distribute itself between two immiscible phases, like how a drug might move between your blood and tissues, or how a pollutant might spread through soil and water.
A partition coefficient, denoted as P or log P, describes the ratio of the concentration of a compound in one phase (usually organic) to its concentration in another phase (often water) at equilibrium.
Higher values of P indicate a greater preference for the organic phase, meaning the compound is more lipophilic (fat-loving).
Lower values of P suggest a higher affinity for the aqueous phase, implying the compound is more hydrophilic (water-loving).
Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)RAHUL PAL
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
The Utilization of Response Surface Methodology (RSM) In the Optimization of ...RAHUL PAL
The objective of the current studies to enhance the formulation of DS-loaded liposomes through the utilization of Response surface methodology (RSM) and involving the computation approach for their validation.
Investigational outcome represents the perceived responses were in related with the desired values and this represents the relationship of the RSM for optimization of % DR and % EE in DS loaded liposomal preparations.
Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Lab...RAHUL PAL
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal
hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
Research Article Published: "Optimization and formulation of dox loaded lipos...RAHUL PAL
Doxorubicin (DOX) is a potent anticancer drug, but it is also associated with significant side effects, such as cardiotoxicity. Liposomal encapsulation of DOX can help to reduce these side effects and improve the drug's efficacy.
There are a number of different factors that can affect the optimization and formulation of DOX-loaded liposomes, including:
Lipid composition: The type and ratio of lipids used to form the liposomes can affect their size, stability, and drug encapsulation efficiency. Some commonly used lipids for DOX liposomes include hydrogenated soy phosphatidylcholine (HSPC), cholesterol, and distearoylphosphatidylglycerol (DSPG).
Drug loading method: There are a number of different methods for loading DOX into liposomes. Some common methods include the ammonium sulfate gradient method, the remote loading method, and the ethanol injection method. The choice of loading method can affect the drug encapsulation efficiency and stability of the liposomes.
Liposome size: The size of the liposomes can affect their circulation time in the body and their ability to target specific tissues. Smaller liposomes tend to have a longer circulation time and are better able to penetrate tumors.
Surface modification: Liposomes can be surface-modified with various ligands to improve their targeting and delivery properties. For example, liposomes can be conjugated with antibodies to target specific cancer cells.
The optimization of DOX-loaded liposomes is typically carried out using a quality by design (QbD) approach. QbD is a systematic approach to drug development that focuses on identifying and controlling the critical quality attributes (CQAs) of the drug product. The CQAs of DOX-loaded liposomes may include particle size, drug encapsulation efficiency, stability, and in vitro and in vivo performance.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
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.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
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!
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
3. INTRODUCTION
3
IRB/IEC serves as an independent body that reviews,
evaluate, approves and decides on the scientific and
ethical aspects of the clinical trial protocol as well as
the benefits and risks to the study participants.
Main purpose of IRB/IEC is to protect the rights,
safety and well being of the subjects who participate
in a trial.
4. BACKGROUND
• National research act passed by congress on July 12, 1974, mandated
establishment of IRB/IEC.
• Act provide national commission for protection of human subjects of
biomedical and behavioral research and lead to publication of The Belmont
Report in 1979.
• The amended regulation on July 27, 1981.
• Submission of NDA’S approval of IRB is necessary.
4
5. COMPOSITION
IRB Consists of members, who
• Collectively have the qualifications
and experience to review and evaluate the science, medical aspects and
ethics of the proposed trials.
• Include at least five members, of which at least one members whose primary
area of interest is nonscientific discipline and at least one member who is
independent of the institutional/trial site.
5
IRB/IEC
6. IRB/IEC MEMBERSHIP
Members of ICE:
• Chair person.
• 1-2 basic medical scientists.
• 1-2 clinicians from various institutes.
• One legal exert or retired judge.
• One social scientist, One philosopher/ethicist.
• One lay person.
• Member secretary.
6
IRB/IEC
7. RESPONSIBILITIES OF IRB/IEC
The Committee has been designated to-
• Approve
• Monitor
• Review biomedical and behavioral research, involving humans with the aim to
protect the rights, safety and welfare of the research subjects.
• Safeguard the rights, safety and well-being of all trial subjects.
• Reviews a proposed clinical trial within a reasonable time and documents its view
s in writing.
• Conducts continuing review of each ongoing trails at least once per year.
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8. PROCEDURE OF IRB/IEC
• Determines its composition and authority under which it is established.
• Schedules, notifies its members of, and conducts its meetings.
• Conducts initial and continuing review of trials.
• Specifies that no subjects should be admitted to atrial before the IRB/IEC
issues its written approval/favorable opinion of the trail.
• Specifies the information that the investigator should promptly report to
the IRB/IEC (like deviations from the protocol, adverse drug reactions etc)
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10. MAINTENANCE OF RECORD OF
IRB/IEC
• IRB/IEC retains all relevant records (e.g. written procedures, lists of
occupations/affiliations of members, submitted document, minutes of meeting
etc.) for period of at least 3 years after completion of the trial and makes them
available upon request from the regulatory authorities.
• IRB/IEC may be asked by investigators, sponsors or regulatory authorities to
provide copies of its written procedures and membership lists.
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