SEMESTERVIII
BP801T.BIOSTATISITCSANDRESEARCHMETHODOLOGY(Theory)
45Hours
Scope: To understand the applications of Biostatics in Pharmacy. This subject deals
withdescriptive statistics,Graphics, Correlation,Regression, logistic regression
Probabilitytheory,Samplingtechnique,Parametrictests,NonParametrictests,ANOVA,Introd
uction to Design of Experiments, Phases of Clinical trials and Observational
andExperimentalstudies,SPSS,RandMINITABstatisticalsoftware’s,analyzingthestatistical
datausingExcel.
Objectives:Upon completionofthecoursethestudentshallbeableto
• KnowtheoperationofM.S.Excel,SPSS,RandMINITAB®,
DoE(DesignofExperiment)
• Knowthevariousstatisticaltechniquestosolvestatisticalproblems
• Appreciatestatisticaltechniquesinsolvingtheproblems.
Coursecontent:
Unit-I 10Hours
Introduction:Statistics,Biostatistics,Frequencydistribution
Measures of central tendency:Mean, Median, Mode- Pharmaceutical
examplesMeasures of dispersion: Dispersion, Range, standard
deviation,Pharmaceuticalproblems
Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation -
Pharmaceuticalsexamples
Unit-II 10Hours
Regression: Curve fittingbythe methodof leastsquares, fittingthelines y=a+bxandx
=a+by,Multipleregression,standarderrorofregression–
PharmaceuticalExamplesProbability:Definition of probability, Binomial distribution,
Normal distribution,Poisson’sdistribution,properties -problems
Sample,Population,largesample,smallsample,
Nullhypothesis,alternativehypothesis,sampling, essence of sampling, types of sampling,
Error-I type,Error-II type, Standarderrorofmean(SEM)-Pharmaceutical examples
Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One
wayandTwoway),Least Significancedifference
Unit-III 10Hours
Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-
Wallistest,FriedmanTest
Introduction to Research: Need for research, Need for design of
Experiments,ExperientialDesign Technique,plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot
graphDesigningthemethodology:SamplesizedeterminationandPowerofastudy,Reportw
ritingandpresentationofdata,Protocol,Cohorts studies, Observational
studies,Experimental studies,Designingclinical trial,various phases.
Unit-IV 8Hours
Blockingandconfoundingsystem forTwo-level factorials
Regression modeling: Hypothesis testing in Simple and Multiple
regressionmodelsIntroductiontoPracticalcomponentsofIndustrialandClinicalTrialsPr
oblems:StatisticalAnalysisUsingExcel,SPSS,MINITAB®,DESIGNOFEXPERIMENTS,R-
OnlineStatisticalSoftware’stoIndustrialandClinical trialapproach
Unit-V 7Hours
Design andAnalysisofexperiments:
Factorial Design: Definition, 22, 23design. Advantage of factorial
designResponseSurfacemethodology:Centralcompositedesign,Historicaldesign,
OptimizationTechniques
RecommendedBooks(Latestedition):
1. Pharmaceuticalstatistics-
Practicalandclinicalapplications,SanfordBolton,publisherMarcel
DekkerInc.NewYork.
2. FundamentalofStatistics –HimalayaPublishingHouse-S.C.Guptha
3. DesignandAnalysisofExperiments–PHI LearningPrivateLimited,
R.Pannerselvam,
4. Design and AnalysisofExperiments–
WileyStudentsEdition,DouglasandC.Montgomery
BP802TSOCIALAND PREVENTIVEPHARMACY (Theory)
Hours:45
Scope:
The purpose of this course is to introduce to students a number of health issues and
theirchallenges. This course also introduced a number of national health programmes.
Therolesofthe pharmacistinthesecontextsarealso discussed.
Objectives:
Afterthesuccessfulcompletionofthiscourse,thestudentshallbeableto:
Acquirehighconsciousness/realizationofcurrentissuesrelatedtohealthandpharmace
uticalproblemswithinthe countryandworldwide.
Have a critical wayofthinkingbasedon current healthcaredevelopment.
Evaluate alternative ways of solving problems related tohealth
andpharmaceuticalissues
Coursecontent:
UnitI: 10Hours
Concept of health and disease: Definition, concepts and evaluation of public
health.Understanding the concept of prevention and control of disease, social causes of
diseasesandsocial problems of thesick.
Social and health education: Food in relation to nutrition and health, Balanced
diet,Nutritionaldeficiencies,Vitamindeficiencies,Malnutrition anditsprevention.
Sociology and health: Socio cultural factors related to health and disease, Impact
ofurbanization onhealth anddisease, Povertyand health
Hygieneandhealth:personalhygieneandhealthcare; avoidablehabits
UnitII: 10Hours
Preventive medicine: General principles of prevention and control of diseases such
ascholera,SARS,Ebolavirus,influenza,acuterespiratory infections,malaria,chickenguinea,
dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus,
cancer,drugaddiction-drugsubstanceabuse
UnitIII: 10Hours
National health programs, its objectives, functioning and outcome of the
following:HIVANDAIDScontrolprogramme,TB,Integrateddiseasesurveillanceprogram(I
DSP),Nationalleprosycontrolprogramme,Nationalmentalhealthprogram,National
programme for prevention and control of deafness, Universal immunization
programme,Nationalprogrammeforcontrolofblindness,Pulsepolioprogramme.
UnitIV: 08Hours
National health intervention programme for mother and child, National family
welfareprogramme, National tobacco control programme, National Malaria Prevention
Program,National programme for the health care for the elderly, Social health
programme; role ofWHOinIndian nationalprogram
UnitV: 07Hours
Community services in rural, urban and school health: Functions of PHC,Improvementin
rural sanitation, national urban health mission, Health promotion and education inschool.
RecommendedBooks(Latestedition):
1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd
Edition,2010,ISBN: 9789380704104, JAYPEEPublications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by
RoyRabindra Nath, Saha Indranil, 4thEdition, 2013, ISBN: 9789350901878,
JAYPEEPublications
3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek,
6thEdition,2014,ISBN: 9789351522331, JAYPEEPublications
4. EssentialsofCommunity Medicine—
nd
APracticalApproach,HiremathLalitaD,HiremathDhananjayaA,2 Edition,2012,ISBN
:9789350250440,JAYPEEPublications
5. ParkTextbook ofPreventiveandSocialMedicine,KPark,21stEdition,2011,ISBN-
14:9788190128285,BANARSIDASBHANOTPUBLISHERS.
6. CommunityPharmacyPractice,RameshAdepu,BSPpublishers, Hyderabad
Recommended Journals:
1.ResearchinSocialandAdministrativePharmacy,Elsevier,Ireland
BP803ET. Pharmaceutical Marketing Management (Theory)
45Hours
Scope:
The pharmaceutical industry not only needs highly qualified researchers, chemists
and,technicalpeople, butalsorequires skilled managers who cantake the industry forwardby
managing and taking the complex decisions which are imperative for the growth of
theindustry. The KnowledgeandKnow-how ofmarketing managementgroomthe
peoplefortakingachallenging rolein Sales and Productmanagement.
Course Objective: The course aims to provide an understanding of marketing
conceptsandtechniques andtheirapplicationsinthepharmaceuticalindustry.
UnitI 10Hours
Marketing:
Definition, general concepts and scope of marketing; Distinction between marketing
&selling; Marketing environment; Industry and competitive analysis; Analyzing
consumerbuyingbehavior; industrial buyingbehavior.
Pharmaceuticalmarket:
Quantitative and qualitative aspects; size and composition of the market;
demographicdescriptionsandsocio-
psychologicalcharacteristicsoftheconsumer;marketsegmentation&targeting.Consumerprofi
le;Motivationandprescribinghabitsofthephysician;patients' choice of physicianand
retailpharmacist.Analyzing the Market;Roleofmarket research.
UnitII 10Hours
Productdecision:
Classification, product line and product mix decisions, product
lifecycle,productportfolioanalysis;productpositioning;New
productdecisions;Productbranding,packagingandlabelingdecisions,Productmanagementinp
harmaceuticalindustry.
UnitIII 10Hours
Promotion:
Methods,determinantsofpromotionalmix,promotionalbudget;Anoverviewofpersonalselling
,advertising,directmail,journals,sampling,retailing,
medicalexhibition,publicrelations,onlinepromotionaltechniques forOTCProducts.
160
UnitIV 10Hours
Pharmaceuticalmarketingchannels:
Designingchannel,channelmembers,selectingtheappropriatechannel,conflictinchannels,phy
sicaldistributionmanagement:Strategicimportance,tasksinphysicaldistributionmanagement.
Professionalsalesrepresentative(PSR):
DutiesofPSR,purposeofdetailing,selectionandtraining,supervising,normsforcustomercalls,
motivating,evaluating,compensationandfutureprospectsofthePSR.
UnitV 10Hours
Pricing:
Meaning, importance, objectives, determinants of price; pricing methods and
strategies,issuesinpricemanagementinpharmaceuticalindustry.AnoverviewofDPCO(DrugP
riceControlOrder)andNPPA(NationalPharmaceuticalPricingAuthority).
Emergingconceptsinmarketing:
Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial
Marketing;GlobalMarketing.
Recommended Books:(LatestEditions)
1. PhilipKotlerandKevinLaneKeller:MarketingManagement,PrenticeHallofIndia,NewDel
hi
2. Walker,BoydandLarreche:MarketingStrategy-PlanningandImplementation,TataMC
GrawHill,NewDelhi.
3. DhruvGrewalandMichaelLevy:Marketing,TataMCGrawHill
4. ArunKumarandNMenakshi:MarketingManagement,VikasPublishing,India
5. RajanSaxena:MarketingManagement; TataMC Graw-Hill(IndiaEdition)
6. Ramaswamy,U.S&Nanakamari,S:MarketingManagemnt:GlobalPerspective,IndianCon
text,MacmilanIndia,NewDelhi.
7. Shanker,Ravi:ServiceMarketing,ExcellBooks,NewDelhi
8. SubbaRaoChanganti,PharmaceuticalMarketinginIndia(GIFT–
Excelseries)ExcelPublications.
161
SemesterVIII–Elective course on
PharmaceuticalProductDevelopmentNoofHours:3 Tutorial:1
Creditpoints:4
Unit-I 10Hours
Introduction to pharmaceutical product development, objectives, regulations related
topreformulation,formulationdevelopment,stabilityassessment,manufacturingandqual
itycontroltestingofdifferent types ofdosageforms
Unit-II 10Hours
Anadvancedstudy
ofPharmaceuticalExcipientsinpharmaceuticalproductdevelopmentwithaspecialreferenceto
thefollowingcategories
i. Solventsandsolubilizers
ii. Cyclodextrinsandtheirapplications
iii. Non-ionicsurfactantsandtheirapplications
iv. Polyethyleneglycolsandsorbitols
v. Suspendingandemulsifyingagents
vi. Semisolidexcipients
Unit-III 10Hours
AnadvancedstudyofPharmaceuticalExcipientsinpharmaceuticalproductdevelopmentw
ithaspecial referencetothefollowingcategories
i. Tabletandcapsuleexcipients
ii. Directlycompressiblevehicles
iii. Coatmaterials
iv. Excipientsinparenteralandaerosolsproducts
v. ExcipientsforformulationofNDDS
Selectionandapplicationofexcipientsinpharmaceuticalformulationswithspecificindustr
ialapplications
Unit-IV 08Hours
Optimizationtechniquesinpharmaceuticalproductdevelopment.Astudy
ofvariousoptimizationtechniquesforpharmaceuticalproductdevelopmentwithspecifice
xamples.Optimization by factorial designs and their applications.A study of QbD
and itsapplicationinpharmaceutical productdevelopment.
Unit-V 07Hours
Selectionandqualitycontroltestingofpackagingmaterialsforpharmaceuticalproductdev
elopment-regulatoryconsiderations.
