pet syllabus for bioanalytical sciences...page pharmacognosy subtopics: 1....

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PET SYLLABUS

FOR BIOANALYTICAL SCIENCES

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Proprietaryformulation

7. IntroduceAyurvedicandSiddhaFormularyofIndiaandAyurvedicand

SiddhapharmacopoeiaofIndia

8. IntroductiontotheconceptsofSiddha

Modern

MedicineSubtopi

cs:

1. Principlesandpractice

2. APIandconceptofits formulationintoadosageform

3. Different typesDrugFormulations

4. Excipientsinvariousdosageforms

5. DiseaseManagement(ComparisonofASUandModernDrugs)withresp

ecttotheirmodeofaction

a. Diabetes b. Tuberculosis

c. Hypertension

d. Hepatitis

e. Malaria

f. Dengue

g. Influenza

h. Cancer(Chemotherapy andImmunotherapy)

Indiansystems ofMedicine(ASU)–

Ayurveda,Siddha&UnaniSubtopics:

1. Principlesandpracticew.r.t.ASU

2. TypesofDrugFormulationw.r.t. ASU

3. MethodsofManufacture–RawMaterial toFinishedProductw.r.t.ASU 4. Types of Drug w.r.t.ASU 5. Excipientsinvariousdosageform 6. Introduce concept of Classical Ayurvedic formulation and

Page

Pharmacognosy

Subtopics:

1. BasicConcept,History,Scope&CurrenttrendsinPharmacognosy

2. Crude Drugs: basic concept, classification- depending on their

origin& importance (to include Plants and their medicinal uses with

any 10examplesincludingfew ethnobotanicallyimportantplants)

3. Collection,storage,deterioration&adulterationofcrudedrugs

4. Evaluationofcrudedrugs(withreferencetomonographs)

5. Herbariaintroduction

6. Ethnobotany:basic concept,definition,historyandimportance

7. Cultivationofmedicinalplants:advantagesofcultivatedplants,GoodAgr

iculturalPractices,GoodHarvestingPracticesanddocumentation

PrincipleofextractionandIsolationofanalytes

Subtopics: 1. ImportanceofExtraction

2. Physico-chemicalpropertiesofSolutesand solvents

3. Conceptofpartition&PartitionCoefficient

4. Solventproperties

5. Selectionofsolvent

6. Introduction toclassical

methodsofextractionandmodernmethods ofextraction-

advantages &disadvantages

7. Includese.g.

LLE,LME,SPE,MAE,UAE,SFE,SPME,Soxhwave

8. Applicationsofextraction

9. Ionizationanditseffectontheextractionofdrugs

10. The‘Firstlaw ofdrugmetabolism’

11. Matrixcomponents&analyteisolation

12. Concentrationofextracts

13. Isolations offractions

14. Purificationofisolate

Calibrationrecords

7. SignificanceofvalidationincGLP

8. Transferofmethods

9. Documentation

10. cGLPCertification

11. GeneralPrecautions,labelsandsignage’s

12. Personalsafety&Clothing

13. Levelsofsafety

14. Firesafetyandfirefighting

15. OSHAguidelines

PharmacopoeialstandardsandTestingProcedure

Subtopics:

1. Introduction toWHOguidelinesandICHguidelines

2. IntroductiontoISOandCE

3. Introduction to Pharmacopoeias IP, BP, USP (JP, EP where everapplicable)

4. Specified test in Monographs w.r.t liquid formulation(injectable)and solid dosageform(USP,

EP, BP,IP)

DrugAct&Regulations

Subtopics:

1. IndianDrugs

andCosmeticsActw.r.tScheduleY,M,H.IncludeScheduleA,S(introduction)withamendments.

2. Introductiontoforeignguidelinesw.r.tUS,EU,Australia&Japanwith amendments.

3. IntroductiontoCFR21part11withamendments.

GoodLaboratoryPractice(GLP)

Subtopics:

1. Whatis cGLP?

2. PracticingcGLP

3. GuidelinestocGLP

4. GoodLaboratoryPractices:GeneralProvisions,OrganizationandPersonnel, Facilities, Equipment, Testing

Facilities Operation,Test and Control Articles, Protocol for Conduct of a

NonclinicalLaboratoryStudy,DisqualificationofTestingFacilities 5. PreparationofSOPs

Page

QualityControl(QC)andQualityAssurance(QA)

Subtopics:

1. QualityControl,QualityAssuranceandQualityManagementconcepts:Definition andconcept

2. Total Quality Management (TQM): Definition, elements,philosophies

3. Brief overview of QSEM, ICH guidelines with special emphasisonQ-series

4. Qualitybydesign(QbD):Definition,overview,elementsofQbD program,tools.ICH guidelines section8-

12.

5. QC&QA ofModerndrugs andASU drugs-introduction 6. Organization andpersonnel:Personnelresponsibilities,training,hygieneand personalrecords. 7. Auditrequirements 8. Documentmaintenance inpharmaceuticalindustry:Batch

TheoryofChromatographicseparationandTLC

Subtopics:

1. Principlesofchromatographicseparation

2. Introduction tochromatographicseparationtechniques

3. PrinciplesandPracticeofTLC

4. UsesofTLC

5. Somerecommendedsolvents systems

6. DetectionofcompoundsonTLC plates

7. IntroductiontoHPTLCanditsapplications

8. RecentadvancesinTLC

HPLC– 1

Subtopics: 1. PrinciplesandInstrumentation 2. Thechromatographicprocess

Thechromatogram

4. Separationmode

5. Columnchemistry

6. Systemparameters

7. Introduction tovariousHPLCtechniques;

a. Normalphase

b. Reversephase

c. Ion-pairHPLC

d. Ion-exchangeHPLC

e. GelpermeationChromatography

8. HPLCdetectors

a. Introduction

b. Principlesofdetection

c. UniversalandSpecific

d. Detectors

e. Detectorresponse

f. Sensitivityconsiderations

g. Selectivity

9. IsocraticandGradientHPLC

10. ApplicationsofHPLC

11. Recentadvances(FastLC,online extractions,addonpumps,onlinederivatization, multi-dimensionalLC)

GC–I

Subtopics: 1. PrinciplesandInstrumentation

2. Factors that affect the chromatographic separation (Temperature,Typeof columnetc.)

3. GCtechniques 4. Typesofcolumnsand theirapplication

5. Selection of liquid stationary phases (Packed and capillarycolumns)

6. GChardware 7. Introduction toflowandpressurecontrollers

8. Injectiontechniques-oncolumninjection,largevolumeinjection,split -split less, PTV and various auto

injectors- gas sampling aswellasliquidsampling

9. Column Oven- temperature programming, (High /cryogenicoventemperature)

10. Universal and specific Detectors in GC (FID, TCD, ECD, FPDand NPD)

Spectroscopy–I

Subtopics:

Introduction toatomicandmolecularSpectroscopy

2. UV,Visibleand fluorescence

a. Principle,Instrumentation

b. Applications

3. NephelometryandTurbidometry


b. Applications

4. IRandRamanSpectroscopy


b. Applications

5. Introduction andApplicationofATR

6. NMR


b. Applications

Overviewofproteomics

a. Methodsforcelldisruption/proteinextraction

b. Proteinpurification/Fractionation

c. Proteinidentificationandcharacterization

4. Posttranslational(invivo) and Chemical(invitro)

modificationsofProteins

Electrophoresis

Subtopics:

1. BasicProteinChemistry

2. Principlesofelectrophoreticseparation

3. Equipmentandprocess

4. Agarosegelelectrophoresis

5. PAGE – Native & SDS, 2DGE, Extensions of Electrophoresis-

Immunoelectrophoresis/pulsefield

6. Standardizationof electrophoretictechnique 7. Detectiontechniquesshouldalsoincludeblottingtechniques

8. Applicationsofelectrophoresis

Bioinformatics

Subtopics:

1. Whatisbioinformatics?

2. DatabasesandSearchTools

3. Applicationsofbioinformatics

a. Genomics

b. Proteomics

c. Drugdiscovery(Dockingsoftware)

d. Otherinsilicomethods

4. Using various libraries & tools w.r.t structure/ literature to

drugdevelopment/proteins 5. Introductionto Chemi-informatics

Title

OMICS

Subtopics:

1. IntroductiontoOmics:

a. Genomics

b. Proteomics

c. Metabolomics d. Lipidomics

2. SignificanceofGenomeand proteome

Page

EnvironmentalIssuesofBioanalytical laboratory

Subtopics:

LaboratoryWaste:Management,controlandRegulatoryissues

1. IntroductiontotypesandsourcesofLaboratorywaste

2. Chemical&Biologicalmaterials:HazardsandHandling

3. HazardControls&Information(WorkplaceHazardousMaterialsInf

ormationSystem{WHMIS}asexample)

4. Introductionto: a. ChemicalStorageandSegregation b. ChemicalLaboratoryEmergencyResponse

c. EquipmentSafety

d. LaboratoryInspections

e. TransportationandReceivingofHazardousMaterials

5.RegulationsofPollutionControlBoardforLaboratories.

RandDinPharmaindustryandRecenttrendsinIndianPhar

maceuticalindustry– I

Subtopics:

1. HistoricalbackgroundwithemphasisonPost1947period

2. MagicRemedyAct

3. Markettrendsandactivities 4. Govt.initiativesandthe publicsector inPharmaceuticalIndustry 5. TheroleofDrugPricingpolicyinIndiaandits impactonthe

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Page

IndianPharmaceuticalIndustry

6. PharmaR&Dandtheirstrategies

7. Concept ofNCE andnewdrugdevelopment onBiosimilars,MABs

andPhytochemicals

8. Bioassays- Introduction (Principle, purpose and types -invitro,

invivo), Qualitative and Quantitative with examples,

advantagesanddisadvantages

SPE,SCFE

Subtopics:

1. SPE

a. Introduction

b. Generalpropertiesofbondedsilicasorbents

c. Sorbent/analyteinteractions

d. Samplepretreatmentof differentbiologicalmatrices

e. DevelopingSPEmethodswithexample

f. Othernewdevelopments

2. SCFE,

a. Concept

b. Instrumentation

c. Factorsaffecting

d. OnlineSCFE

e. Automationinextraction

f. QuenchersMethodsofextraction

g. AdvantagesandDisadvantages

h. Applicationfornaturalproducts

i. -Futureperspectives

Phytochemistry

Subtopics:

1. Naturaldrugsubstancesfromplants(primaryandsecondarymet

abolites)

2. Broadclassificationofsecondarymetabolites

a. Nitrogenous

b. Non-nitrogenous

c. Isoprenoids

3. Secondary drug metabolite production with special

referencewithintegrated pathway

4. KeyFactorsaffectingsynthesisofsecondarymetabolites

5. ExtractionTechniquesofCrudeplantmaterial

Page

RandDinPharmaindustryandRecenttrendsinIndianPhar

maceuticalindustry– II

Subtopics:

1. Introduction to Biopharmaceuticals andpharmaceuticalbiotechnology.

2. Biopharmaceuticals:currentstatus andfutureprospects

3. Genericandbrandedbiopharmaceuticals

4. Overviewoflifehistoryfordevelopmentofbiopharmaceuticals.

5. Discoveryofproteinorpeptidebasedtherapeutics:

a. In-silico

b. Pharmaco-informatics.

6. Pre-clinicaltoxicityassessment

7. Clinicaltrial phasesanddesign

8. Clinicaldatamanagement

9. ConceptofPharmacovigilance

IPRandPatenting-I

Subtopics:

1. ConceptofIPR-

UnderstandingthemeaningofIPR&itssignificancein knowledge-

based economy.

2. Types of IPR - Patents, Trade Marks & Service Marks,

DesignRegistration, Trade Secrets, Geographical indications,

ProtectionofNewPlantVarieties,Copyright.

3. Global Harmonization - Impact of IPR on global trade and

theneedforharmonization,WTOanditsroleinaglobalharmonization

, TRIPS and introduction to the articles in TRIPsdocument.

4. InternationalAgreementsrelatedtoIPR&patents-

ParisConvention,PCT, BudapestTreaty,UPOV

StabilityStudies

Subtopics:

1. Factorsthat influencestabilityofdrugformulations

2. TypesofStabilitychambersandtheirdesignconsiderations

3. StabilityissuesofASUrawmaterialsandfinishedproducts

4. Accelerated methods, Shelf Life determination of

Drugsubstances and Drugproducts.

5. WHOandICHguidelinesforstabilitytesting

6. ApproachestostabilitystudiesofASUformulations

Page

IPRandPatenting-2

Subtopics:

1. IndianPatentAct–

a. Criteria to be fulfilled for Patentability- new/novel, non-

obvious/inventivestep,useful/capableofindustrialapplication. b. Non-patentablesubjectmatter -whatisnotpatentable. c. ConceptofMailboxandEMRandhowithashelpedIndiainits

transition tofullTRIPScompliance.

d. How India has leveraged the flexibilities provided by

TRIPStosafeguardtheindustryandpreventever-

greeningofpatents.

e. ProvisionalPatents,DivisionalPatents&PatentsofAddition.

2. IPRas astrategictool–

a. Role of patentee and patent offices in patent

managementincluding lab documentation, confidentiality

agreements, pre-andpost-grantopposition,servicing ofpatents.

b. Conceptsofpiracy,reverseengineeringandknowledgeworker.

c. Benefitsofcreatingand/orowningPatentsandotherIPR.

d. IPclearance–

Precautionsbeforelaunchingofproductanywherein theworld

e. Basics of Patent Searching, Introduction to Patent

Databases,ConceptsofFreedomtooperate(FTO)searchandanal

ysisforpatents,Exclusivity andSPC statuscheck

f. OtherIPRchecksliketrademarks,copyrights(forprinteddataonl

eaflets, packagesetc.),

g. Putting IPR related disclaimers while advertising product

listorsellingproducts.

PackaginginPharmaindustry

Page

Subtopics:

1. IntroductiontoPackaging

2. FundamentalsofDistribution

3. PackagingForms&theirSignificance

4. PackagingMaterials(coveringbasicmanufacturingprocess,ap

plications andsignificance)

5. Paper, Paper Board and CFB Glass, metals, Basic Polymer

basedmaterials,Polymerbased compositematerials

6. AncillaryMats

7. PackageMaterialTesting

8. Compatibility&MigrationStudies

9. AcceleratedShelf Life Testing -TheoryandProblems.

10. cGMP

11. PackagingValidation

12. PackagingLawsandregulatorycompliance

HPTLC

Subtopics:

1. PrinciplesandInstrumentation

2. HPTLCvs TLC

3. Densitometry &quantitationin HPTLC

4. HPTLCinfingerprinting&QC

5. Troubleshooting

6. ApplicationsofHPTLC

7. RecentadvancesinHPTLC

HPLC–II

Subtopics:

ChiralHPLCanditsadvantages

2. ColumnswitchinginHPLC

3. Columnconditions

4. Automation inHPLC

5. UPLCand2DLC

a. PrincipleandInstrumentation

b. Application,Advantagesanddisadvantages

6. HPLCdetectors

a. Radiometricdetectors

b. MALSdetector

7. SCFC

a. PrincipleandInstrumentation

b. Factorsaffecting

c. Application

d. Advantagesanddisadvantages

8. ManualandElectronicDataProcessing

9. Troubleshooting

GC–II

Subtopics:

1. Pyrolizer

2. DerivatisationforGC

3. HeadSpaceGC

4. 2DGC/GC-GC

5. GCstrategyforanalysis involvingbiologicalmatrices

6. Troubleshooting

7. Applications

Spectroscopy–II

Subtopics:

1. Emissionspectroscopy

2. CircularDichroism(CD)andOpticalRotaryDispersion(ORD)


b. Application

3. FlamePhotometryandAtomicEmissionSpectroscopy

a. Principle,instrumentation

b. Applications

4. AAS


b. Applications

5. ICP


b. Applications 6. X –raydiffraction/X-rayFluorescence


Page

b.Applicationsshouldincludepolymorphism

7. C-13 NMR and2DNMR


b. Applications

NCEandits developmentintoaNew DrugandEnzymes

Subtopics: 1. Drugdiscoveryanddevelopment 2. Detaileddescriptionofitsvariousstagesinitsdiscoveryand

developmentofNCE

3. Introduction andapplicationsofenzymes

4. Definition,Classification,Nomenclature,ChemicalNature,Properti

es of Enzymes, Mechanism of Enzyme Action, ActiveSites,

Enzyme Specificity, Effect of pH, Temperature,

SubstrateConcentration on Enzyme Activity, Enzyme Kinetics,

Michelis -MentenEquation,TypesofEnzymeInhibitions-

Competitive,Uncompetitive,Non-

CompetitiveAllostericModulatorsCo-Factors,Zymogens

5. Enzyme as Therapeutics agents, as diagnostics, as catalyst

inprocesses asdrugtarget

Immunoassay&ELISA

Subtopics:

1. Immunoassay:

a. Introduction

b. Reagentsrequiredforimmunoassaydevelopment

c. Basicmethodologyinvolvedinpharmaceuticalanalysis

d. Immunoassaymethodsappliedinpharmaceuticalanalysis

- Radioimmunoassay

- Enzymeimmunoassay

- Fluoroimmunoassay

- Chemiluminescenceimmunoassay

- Liposomeimmunoassay

2. AdvancesinImmunoassaysforpharmaceuticalanalysis

Page

BasicPharmacokinetics,PharmacodynamicsandDrugproperties

Subtopics:

1. BasicconceptsofPharmacokinetics&pharmacodynamics

2. Differentpharmacokinetic&pharmacodynamicsparametersandthe

irmeanings

3. Basic techniques of evaluating Pharmacokinetic

andpharmacodynamicsparameters

4. Basic types of models in pharmacokinetics

&pharmacodynamics

5. General classificationofDrugsandtheirformulations 6. Physicochemicalpropertiesof drugsaffectingADME

7. ConceptsofDrugMetabolism&eliminationwithexamples

8. AdverseDrugreactions(ADRs)

9. SeriousAdverseEvents(SAEs)

LaboratorySafetyMeasuresw.r.thandlingofchemicalsandbiol

ogicalmaterials

Subtopics:

1. Materialhandlinganddisposal

2. TheNewSafetyDataSheets(SDS),

MaterialSafetyDataSheets(MSDS)andSOP(StandardOperatingP

rocedure)

3. WorkinginBiosafetyCabinetsandhoods

4. Levelsofsafety

5. Safedisposalofinfectiouslaboratorywaste.

BasicMicrobiologyanditsapplicationinpharmaceuticals

Subtopics:

1.Microbes & Their environment, Significance and scope of

Microbiology, Biodiversity and types of Microorganisms,

Visualization of Microorganisms: staining and Simple and

compoundmicroscopy,Electron Microscopy

2. GrowthofMicroorganisms,methodstostudygrowthofmicroorganisms,p

reservationofmicroorganisms,maintenancemedia,etc

3. Sourcesofantimicrobialagents:plantsandmicroorganisms,therapeuticA

ntimicrobialAgentsE.g.Erythromycin,AmphotericinB,Cephalosporins

and their commercial production, Antimicrobial DrugResistanceand

DrugDiscovery

Page

Genomics

Subtopics:

1. NucleicAcidchemistry

2. PrinciplesofDNAsequencing

3. DNA&RNAprobes

4. ConceptsofGenemanipulation(introductiononly)

5. Restrictionenzymes&theiruses

6. Vectors&theiruses

7. ProducingTransgenicorganisms

8. Hybridomatechnology

9. cDNAproduction&applications

10. Genelibraries&applications

BasicandRegulatory Toxicology

Subtopics:

1. Introduction,scopeandtypesoftoxicologicalstudies.

2. Toxicants,theirrouteofentry,distribution

3. Metabolism&eliminationoftoxicants

4. ConceptofLD50,ED50Title:RegulatoryToxicology

5. Typesoftoxicitystudies

6. Designconsiderations.

7. Evaluationofresults

8. Extrapolationtoman.

9. OECDGuidelinesonToxicologicalstudies

10. ScheduleYanditsinterpretation.

RegulatoryMicrobiology anditsapplication

inpharmaceuticalandfoodindustry

Subtopics:

1.Asepsis,SterilizationandDisinfection,conceptofDeathcurveof

microbialpopulation,Asepticfillinginpharmaceuticalindustry,

Classification Clean rooms / Clean areas, QA and QC

inMicrobiologyLaboratory

2. Important Microbes for Food & Drug Industry,

PathogenicOrganisms in Food &PharmaIndustry

3. Sources of contamination, Microbial Contamination in

ASUpreparations

4. RegulatoryMicrobiologicaltestinginpharmaceuticals

5. MicrobiologicalAssaysforpharmaceuticalproducts

1. Desk

Page

MSbasics

Subtopics:

1. Theory

2. Components

a. Inlet(Direct,membrane,insertionprobes,etc.)

b. Ion sources (EI, CI, FAN, Thermospray, particle beam,

ESI,APCI,APPI, MALDI,etc.)

c. Analysers (Magnetic sector, Quadrupole, Ion Trap, TOF, FT-

ICR,Orbitrap, etc.) d. Detectors(Electronmultiplier,photomultiplier, Faradaycup,

Microchannelplate,etc)e

.Vacuumsystem

3.MS/MS (TQ,IonTrapandHybrid)

Hyphenation

Subtopics:

1. LC-MSandLC-MS/MS

2. HeadspaceGC,GC-MSand GC-MS/MS(e.g.essentialoils)

3. ICP-MS

4. ScaneventsinTQandothertandem systemsandhybridsystems

5. Recent advances in MS systems (TLC-MS, DART,

DESI,SELDI,etc)

Thermalanalysis

Subtopics:

1.Principle,instrumentationandworkingofTGA,DTAandDSC2.Appl

ications of thermal analysis (including analysis of Bhasma)

3.Recentadvances- hotstagemicroscope

Page

Title:Particlecharacterization

Subtopics:

Usingsuitabletechniquesanalyze:1.

Size 2. Shape 3. Surfacearea

4. Distribution

5. Porosity

6. Rheology

StandardizationofASUdrugs

Subtopics:

1. NeedofstandardizationofAyurvedic drugs

2. Whatdoesstandardizationinvolve?

3. Bioanalyticaltoolsforstandardization

4. ClinicalstudiesinStandardization

5. Approachestostandardization;

6. Rawmaterials

7. In-processmaterials

8. Finishedproducts 9. DevelopingstandardizedQCmethods 10. Shelflife studiesonfinishedproducts

GeneralStatisticalMethods

Subtopics:

1. Basicconceptsofsamplestatistics

2. Conceptofsamplesizeandpower

3. Conceptofrandomisationandsampling techniques

4. Conceptofsignificanceandconfidencelimits

5. Introduction to Various statistical tests - parametric and non-

parametric 6. UseofStatisticalPackagesforDataevaluation

7. Conceptofrandomsamplingandsamplingtechniques

8. Conceptoflevelof significance, power of

testandconfidencelimits

9. Conceptofsamplesize 10. Applicationofnormaldistribution

Page

ConceptsofBiostatistics

Subtopics:

1. Statisticalapproachtobiologicalsamples

2. Variationsinbiologicalsamples& theirstatisticaltreatment

3. IntroductiontoDatacollectiontechniques

4. Designofexperimentswitheg.Blockdesigns,Latinsquare

5. COV and ANOVA

6. Student’sttestandFtest

7. Regressionanalysiswith applicationtoStdGraph

8. Non-parametrictestswithexamples

9. StatisticalGuidancefromregulatoryagencies

10. Student’sTtest,chisquaretest,Z testandFtest

11. SinglesampleandtwosampleNon-

parametrictestswithexamples

12. Useofstatisticalpackagesfordataanalysis(SPSSsoftware)

CurrentGoodManufacturingPractices(cGMP)

Subtopics:

1. Whatis cGMP?

2. Requirements of

cGMPimplementation3.Documentationofc

GMPpractices

4.Regulatory certification of

cGMP5.cGMPinproductionofASUdr

ugs

6. HarmonizationofSOPof manufacture 7. AuditforcGMPcompliances

GoodClinicalPractices(GCP)

Subtopics:

1. OriginofEthicalIssues

2. Ensuringcompliancetoethicalissues3.

EthicalCommittees &theirsetup

4. Regulatory powers of ethical

committees5.Ethicalissuesinanimalstudies

6. DealingwithEthicalissues(subjectcompensationandsubjectrigh

ts) 7. Compliancetocurrentethicalguidelines

What is

GCP?9.OriginofG

CP

10. EarlierGuidelinesforGCP

11. RequirementsofGCPcompliance1

2.GCPguidelinesofICH

13.GCPguidelinesofICMR14

.Ensuring GCP

15. Documentation of

GCP16.AuditofGCPcomplia

nce

Research

MethodologySubtopics

:

1. Basicsofresearchand itstypes

2. Use of digital platforms for

research3.Reviewofliterature 4. Reportwriting 5. Ethicalissues

6. Patentofresearch

7. How to propose and write a research project and information

offundingagencies

AnalyticalMethodValidation

Subtopics:

1. StrategiesforMethoddevelopment

2. WhatandWhyofmethodvalidation

3. Regulatoryrequirementsofvalidation

4. IQ,OQandPQofanalyticalinstruments

5. UseofReferencestandards

6. IssuesofMethod transfer

7. Intraandinterlab –Validation

8. Samplingmethods

9. Calibration of glassware and instruments, concepts of

GoodWeighingPractice

10. UseofReferencestandardsandworkingstandards

11. formatofCertificateof Analysis

Page

BioanalyticalMethodValidation

Subtopics:

1. Validation

2. Guidelines 3. Validationparameters 4. Validationexperiment

Incurred sample

reanalysis6.Validation

protocol

7. Documentationandreporting

8. Need for blood stability in method

validation9.Freeze&thawstability

10.Inter&intradayprecisionandaccuracyanalysis.

BioassaysinPharmaceuticalevaluation

Subtopics:

1. General idea about bio assay systems used in

pharmaceuticalevaluations

2. Invitroassaysandinvivoassays

3. Ethicalissuesofusinganimalassaysystems

4. Alternativestoanimalassays–oneortwoexamples

5. PharmacopoeialBioassays-IP

PolymeraseChainReaction(PCR)&DNAFingerprinting

Subtopics:

1. TypesofPCR&itsapplications

2. DNAamplificationw.r.titsapplications

3. DNAfingerprintingandapplications

4. Useofgenomictechniquesindiagnostics

5. Introduction

toNGS(NextGenSequencing)forgeneticdisorders

Automationandanalysis

Subtopics:

1. Automation anditsadvantagesinsample preparation

2. Automationinbioanalysis

3. Advancedautomatedliquidhandlingsystems

4. RoboticWorkstations

5. HighthroughputScreening

Page

CapillaryElectrophoresis

Subtopics:

1. Introduction

2. Howcapillaryelectrophoresisworks

3. Whycapillaryelectrophoresisworks

4. CEhardware

5. Useinbio-analysis

6. Introduction toCE-MS

Page

ApplicationsofQuantitativeAnalysisforDrugs

Subtopics:

1. MSquantitationwithexample

2. Macromoleculequantitationwith example

ApplicationsofQualitativeAnalysis

Subtopics:

1. Techniqueofgeneratingdrugmetabolites

2. MetaboliteIdentification

3. Impurityprofiling(e.g.genotoxicimpurities,leachable,ex

tractable,etc.)

ResidueanalysisinFood

Subtopics:

1. Pesticides

2. Antibiotics

3. Residualsolvents

4. Mycotoxins

Tracer techniquesinBioanalyticalassays

Subtopics:

1. ConceptofRadioactivity&Halflife

2. ∝,β,γemittersandtheirbiologicalapplications

3. Using tracersinassays

4. Detectorsandcounters

5. Conceptofautoradiography

6. Radiolabelledprobesandtheiruses

7. Radiopharmaceuticals

8. Radiologicaldetectorforchromatography(radiometricde

tector)

Page

RegulatoryAspects ofASU drugs

Subtopics:

1. National initiativesforregulationofASUdrugs

2. ScheduleTandScheduleYofDrugsandCosmeticsAct

3. International

initiativesforregulationofASUdrugswithspecialreferenceto

a. WHOguidelinesontraditionalmedicine

b. ApproachesofUSandEUtoASUdrugregulation

4. ProvisionsofDrugsandCosmeticsActappliedtoASU(e.g.Sche

duleTandY)

EnvironmentalSafetyinBioanalyticallaboratory

Subtopics:

1. Strategiesto

reduceenvironmentalimpactofBioanalyticallaboratory

2. StandardsofLaboratorySafety(IncludingBiosafetyLevels)

3. OverviewofguidelinesforlaboratorieshandingRadioactivesub

stances

4. IntroductiontoISO14001andOSHAS 18001.

5. IntroductiontoEnvironmentImpactAssessment&Reporting

6. Biodiversity:RedDataBook,EndemicandendangeredMedicinal

Plant Species, Conservation and sustainable use ofmedicinal raw

materials, Introduction to Wildlife Act of India &CITES

7. CarbonfootprintsandCarboncredits.

ElectronicDataManagement

Subtopics:

1. ElectronicAcquisitionof data

2. ManagementofdatainComputers

3. ElectronicDataValidationandregulatoryrequirements

4. Electronicsignatures&its regulation

5. Generatingreportsusingcomputers

6. RegulatoryrequirementsofDataevaluation

7. LIMSandits applications

Page

RegulatoryIssues

Subtopics:

1. OTCdrugs

2. Cosmetics

3. Foodsupplements

4. Nutraceuticalsw.r.t.FSSIregulations

Page

Pharmacovigilance

Subtopics:

Introductionto:

1. Pharmacovigilance

2. Pharmacogenomics

3. Pharmacoeconomics

4. Pharmacometrics

Bioavailability–Bioequivalence(BA-BE)

Subtopics:

1. WhatisBAandBE?

2. DesignofaBAandBEstudy 3. ConductofaBAandBEstudy

4. FactorsthatinfluenceBA-BEofadrug

5. Estimating BA-BEparametersof adrug

6. Parametersto evaluateBA-BEofadrug

7. Datacollection,recordingand evaluation

8. ReportingaBA-BEstudy

9. RegulatoryrequirementsofBA-BE

10. EstimatingPharmacokineticparameters

11. AssessmentofBioequivalence

QCandQAofASUdrugs

Subtopics:

1. HerbalpharmacopoeiaandAyurvedic FormularyofIndia

2. ApproachestoQualitycontrolofASUformulations

3. Govtinitiatives

4. SomeInitiativesfrommanufacturers

5. QCofRMandIn-processmaterials (someexamples)

6. QC/OAforfinishedproducts (someexamples)

7. Applications of Herbal pharmacopoeia and

AyurvedicFormularyofIndia

8. RecentadvancesinQualitycontrolofASUformulations

9. QC / OA for finished products (some examples like Taila,

Vati,Churna,Sufoof, Jawarish,Majoon,etc.)

Therapeuticdrug monitoring

Subtopics:

1. PurposeoftherapeuticDrugMonitoring

2. Bioanalyticaltechniquesin TDM

3. AnalyticalandpracticalissuesofTDM

4. Pharmacoeconomicsof TDM

5. Regulatory aspectsofTDMwithcasestudies