PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS,PHARMCY SUBJECTS,THEIR TOPICS AND TEXT BOOKS AND REFERANCE BOOKS
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PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS
1. Pharmacoepidemiology :
Definition and scope:
Origin and evaluation of pharmacoepidemiology need for pharmacoepidemiology, aims andapplications.
Measurement of outcomes in pharmacoepidemiology
Outcome measure and drug use measures
Prevalence, incidence and incidence rate. Monetary units, number of prescriptions, units of drugs dispensed, defined daily doses and prescribed daily doses, medication adherence measurement
Concept of risk in pharmacoepidemiology
Measurement of risk, attributable risk and relative risk, time-risk relationship and odds ratio
Pharmacoepidemiological methods
Includes theoretical aspects of various methods and practical study of various methods with the help of case studies for individual methods
Drug utilization review, case reports, case series, surveys of drug use, cross – sectional studies, cohort studies, case control studies, case –cohort studies, meta – analysis studies, spontaneous
reporting, prescription event monitoring and record linkage system.
Sources of data for pharmacoepidemiological studies
Ad Hoc data sources and automated data systems.
Selected special applications of pharmacoepidemiology
Studies of vaccine safety, hospital pharmacoepidemiology, pharmacoepidemiology and risk management, drug induced birth defects.
2. Phrmacoeconomics:
Definition, history, needs of pharmacoeconomic evaluations
Role in formulary management decisions
Pharmacoeconomic evaluation
Outcome assessment and types of evaluation
Includes theoretical aspects of various methods and practical study of various methods with the help of case studies for individual methods:
Cost – minimization, cost- benefit, cost – effectiveness, cost utility
3. Applications of Pharmacoeconomics
Software and case studies
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What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic resitance and Antibiotic resistance mechanism
Antioxidants food suppliments
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Cleen Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry
Article on Pharmaceutical Industry pharmaceutical industry
Here are some interesting articles on Quality assurance systems for pharmaceutical company
1.Quality assurance in pharma industry
2.Quality by designe concept for pharmaceutical industry
3.Quality by designe concept in pharmaceutical industryan explanation
This website is written by experts in Pharmaceutical Industry Manufacturing Research and Development and Regulatory Affairs Since 2008 and in 2011 Awarded as one of top 10 websites across world in Pharmaceutical Manufacturing Regulatory
USFDA WHO GMP Guidelines Pharmaceutical Regulations Information about Pharma Quality Managment System Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test
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This website consist of detail Information about Pharma Guidelines Pharma Regulatory Affairs USFDA Guidelines WHO Guidelines Pharmaceutical Quality Management System Pharma Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test
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