BIOSTATISTICS AND RESEARCH METHODOLOGY PHARMCY SUBJECTS,THEIR TOPICS AND TEXT BOOKS AND REFERANCE BOOKS
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BIOSTATISTICS AND RESEARCH METHODOLOGY
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
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.
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
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
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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What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices – PMN or 510(k)
Antibiotic Definition and classification
Antibiotic resitance and Antibiotic resistance mechanism
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
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
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
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
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
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Article on Pharmaceutical Industry pharmaceutical industry
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3.Quality by designe concept in pharmaceutical industryan explanation