This document provides information on establishing pharmacovigilance programs and resources in pharmacovigilance. It discusses the importance of classification systems like ATC, ICD, and INN for monitoring drugs and adverse events. Primary resources include clinical trial data and reports, while secondary resources summarize primary sources. Tertiary sources compile information from multiple sources. Establishing an effective pharmacovigilance program requires a structured organization, trained staff, coordination between stakeholders, and support from regulatory authorities and healthcare priorities. Monitoring drug safety is crucial for public health.
This document discusses information resources in pharmacovigilance. It defines pharmacovigilance as relating to detecting, assessing, understanding, and preventing adverse drug reactions. It outlines the objectives to understand drug information sources and select appropriate ones. It describes primary, secondary, and tertiary resources, providing examples and advantages and disadvantages of each. It also discusses establishing pharmacovigilance programs and centers, including basic steps, operational requirements, and planning considerations.
Biostat 8th semester B.Pharm-Introduction Ravinandan A P.pdfRavinandan A P
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This document discusses biostatistics and its applications. It begins by providing examples of class averages, disease rates, medication adherence rates, and comparing drug efficacies that demonstrate the need for biostatistics. It then defines biostatistics as the application of statistical methods to biological and medical data. The document outlines the history of biostatistics and discusses its uses in areas like public health, clinical trials, and medicine. It also covers descriptive and inferential statistics, limitations of statistics, and emphasizes that biostatistics provides an important tool for evidence-based decision making in fields involving human health and biology.
BP801T. BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory), Unit-II, Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x
= a + by, Multiple regression, standard error of regression Pharmaceutical Examples, Regression: how well a certain independent variable
predict dependent variable?
Regression: a measure of the relation between
the mean value of one variable (e.g. output) and
corresponding values of other variables (e.g.
time and cost).
Anatomical, therapeutic and chemical classification of drugs.pptxReshmaManeDeshmukh
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This document discusses the Anatomical Therapeutic Chemical (ATC) classification system for drugs. It provides details on the different levels of the classification system and examples to illustrate how a drug is classified. The ATC system divides active substances into 14 main anatomical groups according to the organ or system they act on. Drugs are further classified into subgroups at five different levels including the chemical substance. The document also outlines the inclusion and exclusion criteria for classifying drugs in the ATC system, which is established and maintained by the WHO collaborating centre in Oslo.
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
Introduction to Research - Biostatistics and Research methodology 8th Sem Uni...Himanshu Sharma
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This slide contains B.Pharm Biostatistics and Research methodology 8th Sem. Unit-3 L2 topic- "Introduction to Research"
It contains topics:
1. Introduction to Research
2. Need for Research
3. Need for Design Experiments
4. Experimental Design Techniques
5. Plagiarism
What are the applications of Biostatistics in Pharmacy?pharmacampus
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Biostatistics broadly deals with statistical applications in the context of biological problems, including medicine, pharmacy, and public health. Government organizations, research institutes and industry have been extensively using statistics and biostatistics
Daily Define Dose (DDD) is assumed to be the average maintenance dose per day for a drug used for its main indication in adults. It was first established in 1970 and is a statistical measurement of drug consumption that considers cost, number of units, number of prescriptions, and physical quantity of drug. DDD is issued by the World Health Organization for measuring and comparing volumes of drug use globally, though it does not correspond to an individual's prescribed or recommended daily dose, as dosing is affected by factors like age, weight, disease type and severity. DDD provides a rough estimate of drug consumption trends over time and between regions to evaluate the impact of interventions on prescribing practices.
This document discusses drug use in special situations including geriatric, pediatric, and pregnancy/lactation. For geriatric drug therapy, it notes that the elderly use more medications due to more disease symptoms and that aging affects drug pharmacokinetics through changes in absorption, distribution, metabolism and elimination. For pediatric drug therapy, it describes the developmental changes that influence drug response in infants and children. For drugs in pregnancy and lactation, it emphasizes avoiding non-essential drugs during pregnancy due to risks to the fetus, and that some drugs can pass through the placenta as a potential teratogen.
Transfer from R & D to production.pptxDipeshGamare
油
Transfer from R & D to production :
(Process, packaging and cleaning)
Granularity of TT Process :
(API, excipients, finished products, packaging materials)
Budget preparation and implementation in hospitals is important for effective financial planning and management. A hospital budget is a quantitative forecast of revenue and expenses for a defined period that allows the administration to review services and plans. Key aspects of hospital budgeting include preparing income, expenditure, and equipment accounts. Income considers patient volume and costs while expenditures cover salaries, supplies, drugs, and construction. Implementing the budget ensures resources are allocated according to priorities and needs. Advantages include better financial control, decision-making, and exposing sources of overspending.
This document discusses medication history, which involves identifying and documenting a patient's current and past medications, allergies, and other medication-related information. It is an important part of pharmaceutical care that provides a starting point for medication reconciliation and review. The goals of a medication history include gaining information on prescription/nonprescription medications, perceived benefits/side effects, medication allergies/intolerances, and identifying potential medication problems. The document outlines the components, sources, aspects, and steps involved in conducting a thorough medication history interview.
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SAS and Minitab are statistical software packages used for data analysis. SAS is used to process raw data, perform a variety of analyses, and generate insights to help organizations make better decisions. It has functions to manipulate text and works through data and procedure steps. Minitab is designed for teaching introductory statistics and solving problems in six sigma projects. It allows users to input, manipulate, visualize, and find patterns in data through various statistical tests and quality control charts. Both SAS and Minitab are widely applied in industry, research, and education.
Introduction to Research, Biostatistics, Introduction to Research: Need for research, Need for design of Experiments,
Experiential Design Technique, plagiarism
Social health program; role of world health organization in Indian national p...Dr. Sharad Chand
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The document provides an overview of MedDRA, including:
- MedDRA was developed under ICH to facilitate exchange of safety information. Its maintenance is overseen by an ICH committee.
- It defines MedDRA as a medical terminology used for regulatory processes from pre- to post-marketing.
- MedDRA has a hierarchical structure of System Organ Classes, High Level Groups, High Level and Preferred Terms to classify adverse event information.
The document discusses clinical pharmacy services provided at hospitals. It focuses on ward round participation, drug therapy review, and pharmacist interventions. Key services discussed include participating in ward rounds to optimize patient treatment, monitoring drug therapy through activities like therapeutic drug monitoring and medication order review, endorsing medication charts to prevent errors, and performing clinical reviews to evaluate treatment response and safety. The pharmacist plays an important role as part of the clinical team in these activities to enhance patient outcomes.
The document discusses drug information services and poison information centers. It provides information on:
- The roles and responsibilities of drug information centers (DICs) and poison information centers (PICs), including providing unbiased drug information to healthcare professionals and managing poisoning cases.
- The organization and services provided by DICs and PICs, which include responding to drug-related inquiries, educating patients, and investigating adverse drug reactions.
- Resources that DICs and PICs rely on to provide drug and poison information, such as textbooks, journals, and computerized databases.
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The document discusses establishing pharmacovigilance centers in hospitals to monitor adverse drug reactions. It outlines the steps to set up a center, including obtaining approvals, designing reporting forms, educating staff, and establishing infrastructure for data collection and analysis. Key requirements for an effective center include adequate trained staff, proper facilities, communication systems, and a sustainable source of funding. The center would operate by collecting ADR reports from healthcare professionals and entering the data into a database to help detect safety issues and inform regulation.
The document discusses the importance of medication history interviews. A medication history interview involves collecting detailed information from a patient about all prescribed and non-prescribed medications they have taken. This information includes allergies, adherence to treatments, and use of alternative medicines. Collecting a thorough medication history helps prevent prescription errors, detect potential drug-related issues, and allows healthcare providers to develop better treatment plans by understanding a patient's complete medication use and history. The interview collects demographic data, medical information, and details on both current and past prescription and non-prescription medication use.
Establishment of Pharmacovigilance ProgrammeNipun Gupta
油
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
The document discusses the level of detail that should be provided about active pharmaceutical ingredients (APIs), excipients, finished products, and packaging materials when transferring technology from a source unit (SU) to a recipient unit (RU). For APIs, the SU should provide information such as the manufacturer, synthesis process, impurities, and stability studies. For excipients, the SU should detail the manufacturer, category, properties like solubility, and specifications for different dosage forms. The finished product specifications, storage conditions, and analytical test procedures should also be transferred. Finally, the SU should inform the RU about the suitable packaging, labeling, and ensure the packaging will not degrade the product.
This document provides an overview of biostatistics. It defines biostatistics as the branch of statistics dealing with biological and medical data, especially relating to humans. Some key points covered include:
- Descriptive statistics are used to describe data through methods like graphs and quantitative measures. Inferential statistics are used to characterize populations based on sample results.
- Biostatistics applies statistical techniques to collect, analyze, and interpret data from biological studies and health/medical research. It is used for tasks like evaluating vaccine effectiveness and informing public health priorities.
- Common analyses in biostatistics include measures of central tendency like the mean, median, and mode to summarize data, and measures of dispersion to quantify variation. Frequency distributions are
What are the applications of Biostatistics in Pharmacy?pharmacampus
油
Biostatistics broadly deals with statistical applications in the context of biological problems, including medicine, pharmacy, and public health. Government organizations, research institutes and industry have been extensively using statistics and biostatistics
Daily Define Dose (DDD) is assumed to be the average maintenance dose per day for a drug used for its main indication in adults. It was first established in 1970 and is a statistical measurement of drug consumption that considers cost, number of units, number of prescriptions, and physical quantity of drug. DDD is issued by the World Health Organization for measuring and comparing volumes of drug use globally, though it does not correspond to an individual's prescribed or recommended daily dose, as dosing is affected by factors like age, weight, disease type and severity. DDD provides a rough estimate of drug consumption trends over time and between regions to evaluate the impact of interventions on prescribing practices.
This document discusses drug use in special situations including geriatric, pediatric, and pregnancy/lactation. For geriatric drug therapy, it notes that the elderly use more medications due to more disease symptoms and that aging affects drug pharmacokinetics through changes in absorption, distribution, metabolism and elimination. For pediatric drug therapy, it describes the developmental changes that influence drug response in infants and children. For drugs in pregnancy and lactation, it emphasizes avoiding non-essential drugs during pregnancy due to risks to the fetus, and that some drugs can pass through the placenta as a potential teratogen.
Transfer from R & D to production.pptxDipeshGamare
油
Transfer from R & D to production :
(Process, packaging and cleaning)
Granularity of TT Process :
(API, excipients, finished products, packaging materials)
Budget preparation and implementation in hospitals is important for effective financial planning and management. A hospital budget is a quantitative forecast of revenue and expenses for a defined period that allows the administration to review services and plans. Key aspects of hospital budgeting include preparing income, expenditure, and equipment accounts. Income considers patient volume and costs while expenditures cover salaries, supplies, drugs, and construction. Implementing the budget ensures resources are allocated according to priorities and needs. Advantages include better financial control, decision-making, and exposing sources of overspending.
This document discusses medication history, which involves identifying and documenting a patient's current and past medications, allergies, and other medication-related information. It is an important part of pharmaceutical care that provides a starting point for medication reconciliation and review. The goals of a medication history include gaining information on prescription/nonprescription medications, perceived benefits/side effects, medication allergies/intolerances, and identifying potential medication problems. The document outlines the components, sources, aspects, and steps involved in conducting a thorough medication history interview.
Applications of sas and minitab in data analysisVeenaV29
油
SAS and Minitab are statistical software packages used for data analysis. SAS is used to process raw data, perform a variety of analyses, and generate insights to help organizations make better decisions. It has functions to manipulate text and works through data and procedure steps. Minitab is designed for teaching introductory statistics and solving problems in six sigma projects. It allows users to input, manipulate, visualize, and find patterns in data through various statistical tests and quality control charts. Both SAS and Minitab are widely applied in industry, research, and education.
Introduction to Research, Biostatistics, Introduction to Research: Need for research, Need for design of Experiments,
Experiential Design Technique, plagiarism
Social health program; role of world health organization in Indian national p...Dr. Sharad Chand
油
This topic explains the Social health program; the role of the world health organization in the Indian national program. This is useful for understanding the importance of social health and the role of WHO.
The document provides an overview of MedDRA, including:
- MedDRA was developed under ICH to facilitate exchange of safety information. Its maintenance is overseen by an ICH committee.
- It defines MedDRA as a medical terminology used for regulatory processes from pre- to post-marketing.
- MedDRA has a hierarchical structure of System Organ Classes, High Level Groups, High Level and Preferred Terms to classify adverse event information.
The document discusses clinical pharmacy services provided at hospitals. It focuses on ward round participation, drug therapy review, and pharmacist interventions. Key services discussed include participating in ward rounds to optimize patient treatment, monitoring drug therapy through activities like therapeutic drug monitoring and medication order review, endorsing medication charts to prevent errors, and performing clinical reviews to evaluate treatment response and safety. The pharmacist plays an important role as part of the clinical team in these activities to enhance patient outcomes.
The document discusses drug information services and poison information centers. It provides information on:
- The roles and responsibilities of drug information centers (DICs) and poison information centers (PICs), including providing unbiased drug information to healthcare professionals and managing poisoning cases.
- The organization and services provided by DICs and PICs, which include responding to drug-related inquiries, educating patients, and investigating adverse drug reactions.
- Resources that DICs and PICs rely on to provide drug and poison information, such as textbooks, journals, and computerized databases.
Establishing Pharmacovigilance Centres In Hospital.pptxRushikeshTidake
油
The document discusses establishing pharmacovigilance centers in hospitals to monitor adverse drug reactions. It outlines the steps to set up a center, including obtaining approvals, designing reporting forms, educating staff, and establishing infrastructure for data collection and analysis. Key requirements for an effective center include adequate trained staff, proper facilities, communication systems, and a sustainable source of funding. The center would operate by collecting ADR reports from healthcare professionals and entering the data into a database to help detect safety issues and inform regulation.
The document discusses the importance of medication history interviews. A medication history interview involves collecting detailed information from a patient about all prescribed and non-prescribed medications they have taken. This information includes allergies, adherence to treatments, and use of alternative medicines. Collecting a thorough medication history helps prevent prescription errors, detect potential drug-related issues, and allows healthcare providers to develop better treatment plans by understanding a patient's complete medication use and history. The interview collects demographic data, medical information, and details on both current and past prescription and non-prescription medication use.
Establishment of Pharmacovigilance ProgrammeNipun Gupta
油
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
The document discusses the level of detail that should be provided about active pharmaceutical ingredients (APIs), excipients, finished products, and packaging materials when transferring technology from a source unit (SU) to a recipient unit (RU). For APIs, the SU should provide information such as the manufacturer, synthesis process, impurities, and stability studies. For excipients, the SU should detail the manufacturer, category, properties like solubility, and specifications for different dosage forms. The finished product specifications, storage conditions, and analytical test procedures should also be transferred. Finally, the SU should inform the RU about the suitable packaging, labeling, and ensure the packaging will not degrade the product.
This document provides an overview of biostatistics. It defines biostatistics as the branch of statistics dealing with biological and medical data, especially relating to humans. Some key points covered include:
- Descriptive statistics are used to describe data through methods like graphs and quantitative measures. Inferential statistics are used to characterize populations based on sample results.
- Biostatistics applies statistical techniques to collect, analyze, and interpret data from biological studies and health/medical research. It is used for tasks like evaluating vaccine effectiveness and informing public health priorities.
- Common analyses in biostatistics include measures of central tendency like the mean, median, and mode to summarize data, and measures of dispersion to quantify variation. Frequency distributions are
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2. It provides examples of different types of data like qualitative vs quantitative and discrete vs continuous data. It also discusses different scales of measurement.
3. Biostatistics is defined as the application of statistical methods to biological and health-related studies and it is widely used in areas like epidemiology, public health, and clinical research.
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Classify data into Qualitative and Quantitative data.
Scales of Measurement in Statistics.
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Prepare table or continuous frequency distribution.
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This presentation was delivered in Colombo, Sri Lanka, at the Institute of Sports Medicine to an audience of sports physiotherapists, exercise scientists, athletic trainers, and healthcare professionals. Led by Kusal Goonewardena (PhD Candidate - Muscle Fatigue, APA Titled Sports & Exercise Physiotherapist) and Gayath Jayasinghe (Sports Scientist), the session provided comprehensive training on soft tissue assessment, treatment techniques, and essential sports taping methods.
Key topics covered:
Soft Tissue Therapy The science behind muscle, fascia, and joint assessment for optimal treatment outcomes.
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Sports Trainer Level 1 Course by Sports Medicine Australia A gateway to professional development, career opportunities, and working in Australia.
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Azure Data Engineer Interview Questions By ScholarHatScholarhat
油
Biostatistics Lecture 1 8th Sem B.Pharm AKTU
1. Branch PHARMACY
Biostatistics And Research Methodology (BP801T)
DR. APJ ABDUL KALAM TECHNICAL UNIVERSITY
By
Dr. MANOJ KUMAR SHARMA
Associate Professor
I.T.S College of Pharmacy, MURADNAGAR
Lecture 1
Introduction
3. Introduction
The word statistics conveys a variety of
meaning to people in different walks of life.
The word statistics comes from the Italian
words Statista
( Statement).
4. CONTINTRODUCTION
The German word Statistik
Political state
The word Statistics today refers to either
quantitative information or a method of
delaling with quantitative or qualitative
information.
5. DEFINITION
Statistics is defined as collection,
Presentation, analysis and interpretation of
numerical data.Acc. Croxton & cowden
Statistics is the sciences and art of dealing with
figure and facts.
6. WHAT IS STATISTICS?
Statistics is a field of mathematical
sciences that deals with data.
The word statistics is used both to
refer to a set of data and to a field of
study.
It is concerned with making
decisions under uncertainties that
occur when the data are subjected to
variation.
8. Biostatistics cont
Biostatistics is the branch of statistics
applied to biological or medical
sciences.
Biostatistics is the methods used in dealing
with statistics in the field of health
sciences such as biology, medicine,
nursing, public health etc
9. Biostatistics
It is the science which deals with
development and application of the most
appropriate methods for the:
Collection of data.
Presentation of the collected data.
Analysis and interpretation of the results.
Making decisions on the basis of such
analysis
10. Frequency Distribution
It is a statistical method for summarizing
the data.
A statistical data consist of a list of numbers
related to a research, among those numbers ,
few may be repeated twice and more than
twice.
The repeating numbers in a data set is
termed as frequency; that frequencies are
listed in a table is known as frequency
distribution/table.
11. Objectives of Frequency Distribution
1-To estimate the frequencies of
the population .
2-To facilitate the analysis of
data.
3-To facilitate computation of
various statistical measures.
12. Components of Frequency Distribution
1-Class
Groups according to size of data.
2-Class limit
The smallest and largest possible
measurements in each classes.
*lower limit
*upper limit
13. Cont..
3. Class mark- It is also known as middle
value.
Class mark = 遜(Lower limit+ Upper
limit)
4. Class interval = (Upper limit- Lower
limit)
5. Class Frequency -The number
observations falling in each class.
6. Tally mark-Strokes against each frequency
observed.
14. x Frequency Tally
Marks
10-20 2 11
20-30 5 1111
30-40 5 1111
40-50 4 1111
Classes Class limit
Lower limit 40
Upper limit 50
Class mark
遜(lower +upper)
遜(40+50)
0.5*90=45
15. Frequency distribution types
1.Ungrouped
Frequency distribution These
datas not arranged in group,
these are individual series and
arranging in ascending order.
Example:
From the following ,make a ungrouped
frequency distribution.
11,12,5,3,11,13,17,13,5,5,11,5
17. Frequency Distribution types cont
2. Grouped frequency
distribution- It is based on
classes, forming frequency
distribution table.
Example:
From the following data
construct agrouped
frequency distribution.
3,8,5,2,15,16,13,12,10,19,18,11
19. Uses of frequency distribution
Managing and operating on
frequency tabulated data is much
simpler than operation on raw data.
There are simple algorithms to
calculate median, mean, standard
deviation etc. from these tables.
Statistical hypothesis testing is
founded on the assessment of
differences and similarities between
frequency distributions.
20. Cont.
Some of the graphs that can be
used with frequency distributions
are histograms, line charts, bar
charts and pie charts.
Frequency distributions are used
for both qualitative and
quantitative data.