Sunday, August 8, 2010
BIOSTATISTICS AND RESEARCH METHODOLOGY PHARMCY SUBJECTS,THEIR TOPICS AND TEXT BOOKS AND REFERANCE BOOKS
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BIOSTATISTICS AND RESEARCH METHODOLOGY
Topics
1 Research Methodology
a) Types of clinical study designs:
Case studies, observational studies, interventional studies,
b) Designing the methodology
c) Sample size determination and Power of a study
Determination of sample size for simple comparative experiments, determination of sample size to obtain a confidence interval of specified width, power of a study
d) Report writing and presentation of data
Biostatistics
a) Introduction
b) Types of data distribution
c) Measures describing the central tendency distributions- average, median, mode
d) Measurement of the spread of data-range, variation of mean, standard deviation, variance, coefficient of variation, standard error of mean.
Data graphics
Construction and labeling of graphs, histogram, piecharts, scatter plots, semilogarthimic plots
2.3 Basics of testing hypothesis
a) Null hypothesis, level of significance, power of test, P value, statistical estimation of
confidence intervals.
b) Level of significance (Parametric data)- students t test (paired and unpaired), chi Square test, Analysis of Variance (one-way and two-way)
c) Level of significance (Non-parametric data)- Sign test, Wilcoxan’s signed rank test,
Wilcoxan rank sum test, Mann Whitney U test, Kruskal-Wall is test (one way ANOVA)
d) Linear regression and correlation- Introduction, Pearsonn’s and Spearmann’s correlation and correlation co-efficient.
e) Introduction to statistical software: SPSS, Epi Info, SAS.
Statistical methods in epidemiology
Incidence and prevalence, relative risk, attributable risk
3. Computer applications in pharmacy
Computer System in Hospital Pharmacy: Patterns of Computer use in Hospital Pharmacy –
Patient record database management, Medication order entry – Drug labels and list – Intravenous
solution and admixture, patient medication profiles, Inventory control, Management report & Statistics.
Computer In Community Pharmacy
Computerizing the Prescription Dispensing process
Use of Computers for Pharmaceutical Care in community pharmacy
Accounting and General ledger system
Drug Information Retrieval & Storage :
Introduction – Advantages of Computerized Literature Retrieval
Use of Computerized Retrieval
Reference books:
a. Pharmaceutical statistics- practical and clinical applications, Sanford Bolton 3rd edition, publisher Marcel Dekker Inc. NewYork.
b. Drug Information- A Guide for Pharmacists, Patrick M Malone, Karen L Kier, John E Stanovich , 3rd edition, McGraw Hill Publications 2006
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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.
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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
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Pharmaceutical Manufacturing Guidelines
Reverse Osmosis Membrane Technology RO Water Purification system
SOP for Mechanical Qualification of Dissolution Apparatus
Standard Operating Procedure How to write a SOP
Sterile dosage form manufacturing facility inspection
Sterility testing in sterile dosage form
Sterility testing of Pharmaceuticals dosage forms
Transdermal Drug Delivery System
Ultraviolet light as antimicrobial disinfectant in water for pharmaceutical use
Monoclonal antibodies, Polyclonal Antibodies, What are Antibodies
What is a Biosimilar or Interchangeable Biopharmaceutical
What is clinical trial protocol
Common Technical Document(CTD)
What is drug receptors?How drug resistance occur
First pass metabolism of a drug
Lyophilization Freeze Drying advantages and disadvantages of lyophilization
What is a prion, What is Mad Cow Disease
What is protein binding of drug, Why a drug is bound to protein
What is protein binding of drug, Why a drug is bound to protein
Requirements Transdermal drug delivery system
Ophthalmic Preparation |Ophthalmic solution and suspensions
Monoclonal antibodies, Polyclonal Antibodies, What are Antibodies
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