SIGNIFICANCE OF ANALYSIS FOR SIGNIFICANCE OF ANALYSIS FOR PHARM-DPHARM-D

BYBY

Dr. Dr. MUSHARRAF MUSHARRAF SHAHZADSHAHZAD

PHARMACIST YOU ARE A BOMB..!!!!

PHARMACYPHARMACY►THE ART & SCIENCE OF WHOLE DRUG THE ART & SCIENCE OF WHOLE DRUG

DELIVERY SYSTEM.DELIVERY SYSTEM.PHARMACISTPHARMACIST

► A PERSON LEGALY QUALIFIED & A PERSON LEGALY QUALIFIED & REGISTERED IN DRUG ASPECTS.REGISTERED IN DRUG ASPECTS.

PHARMACY PROFESSION IS A NEED PHARMACY PROFESSION IS A NEED RATHER THAN DESIRERATHER THAN DESIRE

PPPHARMACISTS ARE…!!PHARMACISTS ARE…!!► Pharmacists are true Pharmacists are true

partners working partners working closely with physicians, closely with physicians, nurses chemists, nurses chemists, scientist, manufacturer, scientist, manufacturer, developer, distributor developer, distributor etc. to provide etc. to provide optimized health care optimized health care for the public.for the public.

► Pharmacist a person Pharmacist a person with drug knowledgewith drug knowledge

WHAT IS MEANT BY WHAT IS MEANT BY ANALYSISANALYSIS►Analysis is the process of Analysis is the process of

breaking a breaking a complex topiccomplex topic or or substance into smaller parts substance into smaller parts to gain a better understanding to gain a better understanding of it of it

►In In pharmacy analysispharmacy analysis means means determination of drugs and its determination of drugs and its several parameters to several parameters to optimize QC aspects.optimize QC aspects.

►Here it dealt with sound Here it dealt with sound chemistry knowledge.chemistry knowledge.

SIGNIFICANCESIGNIFICANCE

In the study of analysis pharmacist can In the study of analysis pharmacist can performperform

When have knowledge of analysis………When have knowledge of analysis………► IsolationIsolation► SeparationSeparation► IdentificationIdentification► PurificationPurification►QualificationQualification►Quantification etc.Quantification etc.

SIGNIFICANCESIGNIFICANCEWhen Pharm-D expert in analysis can perform When Pharm-D expert in analysis can perform

its role in these prospects very efficiently…!!its role in these prospects very efficiently…!!► In QC/QAIn QC/QA► Regulation Regulation ► ValidationValidation► In ProductionIn Production►Drug studies (Kinetic, dynamic, effects etc)Drug studies (Kinetic, dynamic, effects etc)► In process controlIn process control► Clinical trial design & evaluationClinical trial design & evaluation►Drug extraction techniquesDrug extraction techniques► Basic tool in R & D. etc.Basic tool in R & D. etc.

PHAMACIST A PROFESSIONL SCIENTIST..!!PHAMACIST A PROFESSIONL SCIENTIST..!!

QC / QA ISSUESQC / QA ISSUESA systematic approach to development that begins A systematic approach to development that begins

withwithpredefined objectives and predefined objectives and emphasizes product andemphasizes product andprocess understandingprocess understanding and process control, based and process control, based

ononsound science and quality risk management.sound science and quality risk management.

Here analysis used to optimize…..!!!!Here analysis used to optimize…..!!!!► Life safety.Life safety.► Improving medicinal characteristicsImproving medicinal characteristics► Fulfilling regulationsFulfilling regulations►Optimization drug characteristicsOptimization drug characteristics► Legal approval of drugsLegal approval of drugs► Adding value to life.Adding value to life.

TOOLS USED HERETOOLS USED HERE………………► Spectroscopic Analysis Spectroscopic Analysis ► Chromatographic Separation Chromatographic Separation ► Sample Preparation Sample Preparation ► High Performance (Pressure) Liquid High Performance (Pressure) Liquid

Chromatography (HPLC) Chromatography (HPLC) ►Gas Liquid Chromatography (GLC) Gas Liquid Chromatography (GLC) ► Radioimmunoassay (RIA) Radioimmunoassay (RIA) ► Enzyme Multiplied Immunoassay (EMIT) Enzyme Multiplied Immunoassay (EMIT) ► Fluorescence Polarization Immunoassay (FPIA) Fluorescence Polarization Immunoassay (FPIA) ► Comparison of Clinical Analytical Assay MethodsComparison of Clinical Analytical Assay Methods

Can be utilized when pharmacist expert in Can be utilized when pharmacist expert in analytical.analytical.

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REGULATIONsREGULATIONs► A process is well understood when:A process is well understood when:► Critical sources of variability are identifiedCritical sources of variability are identified

and explainedand explained► Product quality attributes can be accurately Product quality attributes can be accurately

and reliably predicted overand reliably predicted over► The design space establishedThe design space established for materials for materials

used, process parameters, manufacturing, used, process parameters, manufacturing, transportation, storage, environmental, transportation, storage, environmental, packaging andpackaging and

► Establishment of cGMPs, cGLPs .Establishment of cGMPs, cGLPs .

It is possible if pharmacist expert in It is possible if pharmacist expert in analysis…!!!analysis…!!!

VALIDATIONVALIDATIONA successful validation program depends upon A successful validation program depends upon

information and knowledge from product information and knowledge from product and process development & is the basis for and process development & is the basis for establishing an approach to………….establishing an approach to………….

► Control that is appropriateControl that is appropriate for the for the manufacturing process. manufacturing process.

► UnderstandUnderstand the sources & degree of the sources & degree of variationvariation

► Variation impactVariation impact on process & Product on process & Product attributesattributes

► Control the variation & Risks.Control the variation & Risks.► RepresentsRepresents process and product process and product► FocusingFocusing on qualification on qualification

Classes of analytical Classes of analytical teststests

The objective of validation of an analytical The objective of validation of an analytical

procedure is to demonstrate that it is suitable procedure is to demonstrate that it is suitable

for for iits intented purpose.”ts intented purpose.”

► Class A: To establish Class A: To establish identityidentity

► Class B: To detect Class B: To detect (B(Bdd) ) and quantitateand quantitate (B (Bqq)) impuritiesimpurities

► Class C: To determine quantitatively the Class C: To determine quantitatively the

concentrationconcentration, or , or aassayssay

► Class D: To assess Class D: To assess characteristicscharacteristics

► Other classes not covered in the guidesOther classes not covered in the guides

IN PRODUCTIONIN PRODUCTION

Department for the manufacturing Department for the manufacturing goods, pharmaceuticals or others goods, pharmaceuticals or others utilities.utilities.

A pharmacist expert in analysis can…A pharmacist expert in analysis can…► Provide in-process control efficientlyProvide in-process control efficiently► Provide process change protocolsProvide process change protocols► Establishing & implementing GMPs.Establishing & implementing GMPs.►Method Performance Assessment and Method Performance Assessment and

Control etc.Control etc.

DRUG STUDIESDRUG STUDIES►Pharmacokinetic studiesPharmacokinetic studies►Pharmacodynamic studiesPharmacodynamic studies►TDM studiesTDM studies►Diagnostic studiesDiagnostic studies►Forensic analytical studiesForensic analytical studies►Biopharmaceutical studiesBiopharmaceutical studies►Drug designing studiesDrug designing studies►Drug screening studies etc, & so on.Drug screening studies etc, & so on.

CLINICAL TRIAL DESIGN & CLINICAL TRIAL DESIGN & EVALUATIONEVALUATION

An analytically expert pharmacist can play An analytically expert pharmacist can play role in….!!!!!role in….!!!!!

► Establishing of trial designing.Establishing of trial designing.► Conducting the studies efficientlyConducting the studies efficiently► Evaluating the resultsEvaluating the results►Highlighting the interpretationsHighlighting the interpretations► Technical reporting of errors and Technical reporting of errors and

amendments.amendments.►Working w.r.t cGMPs, cGLPs.Working w.r.t cGMPs, cGLPs.

DRUG EXTRACTIONDRUG EXTRACTION

Pharmacy is profession involving from Pharmacy is profession involving from drug source to its outcomes so drug source to its outcomes so analytically expert pharmacist can…..!!analytically expert pharmacist can…..!!

►Help in extraction of APIs from crude Help in extraction of APIs from crude sourcesource

►Point out their outcomesPoint out their outcomes►Modify methodology involvedModify methodology involved►Can help in better result via derivationCan help in better result via derivation►And several others.And several others.

RESEARCH & RESEARCH & DEVELOPMENTDEVELOPMENT

An active topic in pharmaceutical An active topic in pharmaceutical sector..!!sector..!!

Analytically expert pharmacist itself Analytically expert pharmacist itself can…..can…..

►Drag out mysterious chemicalDrag out mysterious chemical►Modify APIs for potency and activity.Modify APIs for potency and activity.►Derivation of parent compoundsDerivation of parent compounds►Developing and searching new active Developing and searching new active

entitiesentities►All these direct based on analytical All these direct based on analytical

expertness….!!!!expertness….!!!!

HAVE YOU ANY QUESTIONHAVE YOU ANY QUESTION

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