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Sunday, August 8, 2010




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

Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice and latest news and new drugs developments.
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

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

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


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

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