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TEXTBOOK OF COMPUTER APPLICATIONS AND BIOSTATISTICS Dr. S. B. Bhise M. Pharm PhD Principal, Singhad Institute of Pharmaceutical Sciences, Lonavala [email protected] Dr. R. J. Dias M. Pharm PhD MBA Professor, Singhad Institute of Pharmaceutical Sciences, Lonavala [email protected] K. K. Mali M. ...

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TEXTBOOK OF

COMPUTER APPLICATIONS AND BIOSTATISTICS Dr. S. B. Bhise

M. Pharm PhD Principal, Singhad Institute of Pharmaceutical Sciences, Lonavala [email protected]

Dr. R. J. Dias

M. Pharm PhD MBA Professor, Singhad Institute of Pharmaceutical Sciences, Lonavala [email protected]

K. K. Mali

M. Pharm (Biopharm) Associate Professor, Satara College of Pharmacy, Satara [email protected]

P. H. Ghanwat

DIE, MCA Visiting Lecturer, Satara College of Pharmacy, Satara [email protected]

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TRINITY PUBLISHING HOUSE

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Serving Pharmacy Profession

Textbook of Computer Applications and Biostatistics Published by Mrs. Anita R. Dias For Trinity Publishing House, 475/8, F-3, Suryanandan Apartments, Near Hotel Suruban, Sadar Bazaar, Satara - 415 001. India. Mobile: +91 9850953955, +91 8087250235 E-mail: [email protected]

© 2011 Trinity Publishing House All rights reserved. No part and style of this book be reproduced or transmitted, in any form, or by any means- electronic, mechanical, photocopying, recording or otherwise, without prior permission of the publishers and authors.

Disclaimer: As new information becomes available, changes become necessary. The editors/authors/contributors and the publishers have, as far as it is possible, taken care to ensure that the information given in this book is accurate and up-to-date. In view of the possibility of human error or advances in medical science neither the editor nor the publisher nor any other party who has been involved in the preparation or publication of this work warrants that the information contained herein is in every respect accurate or complete. Readers are strongly advised to confirm. This book is for sale in India only and cannot be exported without the permission of the publisher in writing. Any disputes and legal matters to be settled under Mumbai jurisdiction only. ISBN 978-81-920565-1-7 Rs. 350/Printed at Vikram Printers Pvt. Ltd. 31 & 34, Parvati Industrial Estate, Pune-Satara Road, Pune- 411 009. India. Phone: (020)24220890, 24228905. www.vikram-printers.com Designed by Srushti Computers, Satara. G-2, ‘Venna’, Adarshnagar, Khed, Satara. [email protected].

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PREFACE We are very pleased to put forth the first edition of book, ‘Textbook of Computer Applications and Biostatistics’. This book is intended to be an introduction to pharmacy students regarding applications of computers and biostatistics to pharmacy. The basic knowledge of computers and their applications is covered in details as it is essential to students in every walk of their lives. The procedures for operating MS-Office 2003 is discussed here as many colleges still use this version. However our second edition will have the procedures for operating latest versions of Windows. We regret for inconvenience caused to few readers, due to this. The concepts of biostatistics are discussed here with minimum of maths, so as to drive away the maths phobia in pharmacy students. Moreover, most of the statistics can be handled through computers using excel and we have emphasized in every chapter on how to use computers for statistical needs. This will help students to handle the data and infer about their experiments easily. This book is an sincere effort to bring statistical concepts in simple, understandable form so that every student will enjoy to learn them with ease. The learning objectives, summary, multiple choice questions and exercise in all twenty two chapters makes the book more interesting. We acknowledge the help and co-operation extended by various persons in bringing out this book. We are highly indebted to the authors of the various books and articles mentioned in bibliography which became a major source of information for writing this book. We also thank the publishers and designers who graciously worked hard to publish this book in time. Our request to all users of this book is to provide constructive criticism in improving further editions of the book. We sincerely hope that readers will certainly welcome the book.

SB Bhise RJ Dias KK Mali PH Ghanwat

Satara January 15, 2011.

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CONTENTS Chapter No.

1.

2.

3.

4.

5.

6.

7.

8.

9.

Title of the Chapter

Introduction to Computers Introduction, History of computers, Evolution and generations of computers, Characteristics of computer, Types of computers, Applications of computers. Anatomy and Computer Peripherals Anatomy of computer system, Parts of computer system, Hardware, Software, Input devices, Output devices, Memory, Binary numbers in computers, Unit of size, Computer language. Operating System Introduction, Functions, Types of operating systems, MS-DOS, MS-Windows, Working in Paint, Wallpaper, Screensaver. Microsoft Word Introduction, Features of word processing, Opening Microsoft Word, Components of the screen in MS-Word, Creating, editing and saving the document, Formatting the text, Printing a document, Quitting Microsoft Word. Microsoft Excel Introduction, Features of Microsoft Excel, Opening of Spreadsheet, Components of an Excel workbook, Entering data and saving a new workbook, Mathematical calculations, Moving and copying data, Deleting and adding rows and columns, Aligning data, Changing the size of row and column, Creating a graph, Adding, renaming or deleting a sheet from the workbook, Closing the workbook, Quitting Microsoft Excel. Microsoft PowerPoint Introduction, Features of PowerPoint presentation, Starting PowerPoint presentation, Components of MS-PowerPoint, Exploring PowerPoint views, Creating and saving a PowerPoint presentation, Adding slides, chart, picture, text box to a presentation, Duplicating and deleting slides, Adding animation to a presentation, Making slide show, Closing a PowerPoint presentation, Quitting a PowerPoint presentation. Computer Networking and Internet Applications Introduction, Types of networking, Topology, TCP/IP protocol, Advantages of Networking, Internet, Internet connection, Requirements for connecting to the Internet, Internet services, WWW, DNS, URL’s, E-mail, Intranet, Net surfing, Chatting, Computer virus. Applications of Computers to Pharmacy Use of computers in Manufacturing of drugs, Quality control, Quality assurance, Pharmaceutical analysis, Inventory control, Clinical research, Retail pharmacy, Drug information services, Marketing and sales, Hospital pharmacy, Clinical services, Bioequivalence testing, Basic research, etc. Introduction to Biostatistics Definition, Types of statistics, Applications and uses of Biostatistics, Types of variables, Identification of the type of variable. (v)

Page No.

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CONTENTS Chapter No.

10.

11. 12.

13.

14. 15.

16.

17.

18. 19.

20.

21.

22.

Title of the Chapter

Presentation of Data Tabulation of data, Graphical presentation of categorical and metric data, Charting of data using MS-Excel. Shape of Distribution of Data Shapes of data, Bell shaped distribution, Skewness, Kurtosis. Measures of Central Tendency Measures of location: Mode, Median, Mean, Measures of spread: Percentile, Range, Interquartile range, Standard deviation, Use of Excel in measures of central tendency. Probability and Probability Distribution Classic probability, Probability of simple and composite event, Probability involving two variables and conditional probability, Probability distribution. Sampling Techniques Methods of Sampling, Precision, Accuracy and Bias. Estimation of Confidence Interval Concept of confidence interval, Standard error of the mean, Estimation of confidence interval. Hypothesis Testing Hypothesis testing, Decision rule, Types of errors, One-tailed and two-tailed test, Defining the critical region for statistical test. Choice of Statistical Tests Parametric and Non-parametric tests, Choice of statistical tests, Commonly used hypothesis tests. Hypothesis Testing for One Sample One sample z-test, One sample t-test. Hypothesis Testing for Two Samples Two samples z-test, Two samples t-test, Paired t-test, Use of MS-Excel in hypothesis testing for two samples One Way Analysis of Variance (ANOVA) Definition, Calculations of ANOVA by using definitional and computational formula, One way ANOVA using MS-Excel. Correlation Definition, Types of correlation, Calculation of correlation coefficient by definitional and computational formula, Correlation using MS-Excel. Linear Regression Definition, Meaning of regression, Regression coefficient, Linear regression using MS-Excel. Important Points & Formulaes At A Glance Appendices Bibliography

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271 282

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351 354 358

Chapter 8

APPLICATIONS OF COMPUTERS TO PHARMACY Learning objectives When we have finished this chapter, we should be able to: 1. Understand applications of computers to pharmacy. 2. Know various computer programmes used in different areas of pharmacy field. Introduction The utility of computer in collection, evaluation, organisation and dissemination of information has made their presence virtually in every walk of life. Their potential in every field of pharmacy has led to its extensive use encompassing research of drug, its manufacturing and till its proper usage. The following properties of computers have made them to bring biggest revolution of the twenty first century known as information technology. The properties are: 1. Large storage capacity 2. Speed and accuracy 3. Flexibility 4. Ease of dissemination and transmission 5. Multiple user capacity 6. Can do repetitive tasks. Let us see the applications of computers to various fields of pharmacy as given below: 1. Use of computers for manufacturing of drugs The manufacturing of drugs in various dosage forms requires sophisticated instruments and machinery which are now-a-day controlled by computers. The touch screen panels provided to these machines can be utilised for controlling various manufacturing variables thereby producing quality medicines. Automation brought in manufacturing area has increased the efficiency, quality and safety manifold. Computer- aided manufacturing (CAM) is the use of computers to plan and control manufacturing process. A well designed CAM system allows manufacturers to become much more productive. Not only a greater number of products are produced, but also speed and quality is increased. Softwares available: Marg pharmaceutical software for manufacturers, DMC Medical Manufacturing, Taylor Pharmaceutical Manufacturing, TGI Process manufacturing, MISys Manufacturing software, etc.

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2. Use of computers in quality control The quality of medicine is utmost important for any manufacturing plant and every batch has to pass stringent quality control norms. Computers play very important role in quality control department by analyzing and interpreting whether raw materials and finished products match the expected quality norms, as per the specifications given in official book. Softwares available: Darwin LIMS software for QA/QC, DMC quality control software, Monark software for Pharma QC system, MasterControl QC software etc. 3. Use of computers in quality assurance The computers are used in documentation of every process for assuring quality medicine. The preparation of standard operating procedures, validating their use, and ensuring their adherence according to guidelines are few areas where computers are necessary. Softwares available: Qtor Pharmaceutical QA software, EtQ software, Marg QA, DMC QA software, etc 4. Use of computers in pharmaceutical analysis Various analytical methods like high performance liquid chromatography (HPLC), Gas chromatography (GC), Gas chromatography with mass spectrometry (GC-MS), Infrared spectroscopy (IR), UV visible spectroscopy (UV) etc are used for analysing various drugs. Computers are useful in all these techniques for identifying and interpreting the compounds. For example, Gas liquid chromatography separates the individual components and MS identifies it. This operation generates hundreds of spectra in few minutes containing number of peaks. Computer when used for interpretation of this data, stores these spectra for some time and then represents it in the graphical form. For identification of mass spectrometry computer compares the spectrum of the given sample with the spectrum of pure compound. Softwares available: DeWinter, Drug Testing Software Management Suit, DrugPak IPA CoreAnalysis,Assistant Pro 4.1, etc. 5. Use of computers in inventory control The inventory control includes purchasing of raw materials as per the demand, supply of finished goods, distribution of raw materials to various departments, and maintaining the stocks effectively. Softwares can be utilized to provide reports on stock status, opening and closing balance and to prepare purchase orders. Softwares available: mSupply, IMS Leon, Meditab IMS, CASI, DMC, etc. 6. Use of computers in clinical research Computer is utilized for coding of data and statistical analysis of results of clinical trials. Computer process ensures uniformity, completeness and accuracy of data collected from various centres and helps in evaluating efficacy of design protocols on investigational drugs. Computers has been extensively used in multicentric clinical trials on investigational drugs. Softwares available: OpenClinica, TEMPO, Cytel, InferMed, Clinplus, TrackWise, Metadata ClinAxys II, etc.

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7. Use of computers in managing drug store (Retail pharmacy) In retail pharmacy store, inventory control is done using computers. Computers also helps in sales analysis and purchasing of the medicines. Computers can be used for storage of patient records and the drug history profiles. The software are also available which shows drug interactions in prescribed medication and patient instructions to be given. This allows pharmacists to do better patient counseling job. Software available: Dava plus, PharmaSoft, ApotheSoft Rx, PEPID, Essel, Abascus Pharmacy, MediVision, etc. 8. Use of computers in drug information services The vast data is available on drugs and disease state and computerization of this data is needed to retrieve the information needed. The user oriented drug information systems are available whereby drug information guide for patients and full text database of drug is given as ready reckoner. Drug information centres using computers can answer drug related queries like how, why, what and when of medication immediately. Softwares available: MicroMedeX Websites: RxFacts .org, medind.nic.in, www.uiowa.edu, www.health.umt.edu, Lexicomp online, Drugs.com, Davi’s Drug Guide online, etc. 9. Use of computers in marketing and sales The use of computers in every arena of marketing and sales department have made the field more promising and lucrative. In this field computers are used in market research, consumer survey, advertizing, sales promotion campaigns, product management, developing dealer distribution network, sales analysis etc. E marketing is newer concept in which medicines are purchased or sold online eg. Dava Bazaar. Softwares available: Medisno Pharma CRM, Metastorm, Marg online MR software, Marg ethical marketing software, etc. 10. Use of computers in hospital pharmacy Use of computer in managing bigger hospitals have saved a lot of money and man hours. A complete hospital information system is a multiterminal database management system that provides facilities for integrated handling of information regarding registration of patients; investigation, treatment, follow up etc. Some of the other areas covered under this system are inventory control and purchase of medicine, drug information database, adverse effects and drug interaction management, drug distribution within hospital, prescription monitoring and preparation of hospital formulary. Softwares available: Meditab IMS, WinPharm, WorkPath, MediNovs, HMS-Leon, etc. 11. Use of computers in clinical services Computer programmes have been designed to assist in the monitoring of patients with chronic diseases like diabetes, hypertension and asthma. Therapeutic drug monitoring based upon plasma concentration of a drug is possible using computer programmes. Softwares available: NAMAH, Pharmacy Plus, VirtualCare, MEDIPHOR, etc.

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12. Use of computers in bioequivalence testing centres Bioequivalence of generic drugs with reference innovator’s drug is very important regulatory need for marketing off patented drugs. Various bioequivalence centres use computer programes to accumulate, sort and use the data for bioequivalence testing. Softwares available: WinNonlin, DDSolver, EquivTest, MONOLIX, Study Size 2.0, etc. 13. Use of computers in basic research The softwares available today are playing important role in drug design. Computer aided drug design (CADD), Qualitative Structure Activity Relationship (QSAR), Molecular modeling are promising areas that help the researchers in doing their research with ease. Available softwares: AMBER, CHARMM and GROMACS are widely used to carry out molecular modeling. FTDock and DARWIN has tremendous application in the rational drug design process. Other softwares available: Prochemist, Tripos, Oxford Molecular QSAR, HYPERCHEM, MATLAB, DRAGON, RECKON, Spartan, etc. 14. Use of computers in Medicine Many of the modern-day medical equipment have small, programmed computers. Many of the medical appliances of today work on pre-programmed instructions. The circuitry and logic in most of the medical equipment is basically a computer. Computer software is used for diagnosis of diseases. It can be used for the examination of internal organs of the body.Advanced computer-based systems are used to examine delicate organs of the body. Some of the complex surgeries can be performed with the aid of computers. The different types of monitoring equipment in hospitals are often based on computer programming. Medical imaging is a vast field that deals with the techniques to create images of the human body for medical purposes. Many of the modern methods of scanning and imaging are largely based on the computer technology. It has been possible to implement many of the advanced medical imaging techniques, due to the developments in computer science. Magnetic resonance imaging employs computer software. Computed tomography makes use of digital geometry processing techniques to obtain 3-D images. Sophisticated computers and infrared cameras are used for obtaining high-resolution images. Computers are widely used for the generation of 3-D images in medicine. Softwares available: CliniScript, Clinichem, LIFEDATA EMR, LDRA, EasyDiagnosis, Diagnosis Pro, COMPUTER CLINIC, DICOM, 3D-DOCTOR, MIM, etc. 15. Use of computers in Biostatistics Every data generated during the research is to be handled or manipulated carefully for drawing inference from it. Both the types, descriptive and inferential statistics can be applied by researcher using MS Excel or relevant softwares. Softwares available: SigmaStat, GraphPad Prism, Minitab, SPSS, SAS, DesignExpert, SigmaXL, etc.

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