Understand the interaction of matter with electromagnetic radiations and its applications in drug analysis
Understand the chromatographic separation and analysis of drugs.
Perform quantitative & qualitative analysis of drugs using various analytical instruments.
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on absorption spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors-Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications - Spectrophotometric titrations, Single component and multi component analysis
Theory, Concepts of singlet, doublet and triplet electronic states, internal and external conversions, factors affecting fluorescence, quenching, instrumentation and applications
Introduction, fundamental modes of vibrations in poly atomic molecules, sample handling, factors affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell, Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications
Determination of absorption maxima and effect of solvents on absorption maxima of organic compounds
Estimation of dextrose by colorimetry Estimation of sulfanilamide by colorimetry
Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy Assay of paracetamol by UV- Spectrophotometry
Estimation of quinine sulfate by fluorimetry Study of quenching of fluorescence Determination of sodium by flame photometry Determination of potassium by flame photometry
Determination of chlorides and sulphates by nephelo turbidometry Separation of amino acids by paper chromatography
Separation of sugars by thin layer chromatography Separation of plant pigments by column chromatography Demonstration experiment on HPLC
Demonstration experiment on Gas Chromatography
Instrumental Methods of Chemical Analysis by B.K Sharma Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake Organic Chemistry by I. L. Finar
Organic spectroscopy by William Kemp Quantitative Analysis of Drugs by D. C. Garrett
Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi Spectrophotometric identification of Organic Compounds by Silverstein
Know the process of pilot plant and scale up of pharmaceutical dosage forms Understand the process of technology transfer from lab scale to commercial batch Know different Laws and Acts that regulate pharmaceutical industry
Understand the approval process and regulatory requirements for drug products
D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization - practical aspects and problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues
Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php
Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.
appreciate the pharmacy stores management and inventory control
monitor drug therapy of patient through medication chart review and clinical review
obtain medication history interview and counsel the patients identify drug related problems
detect and assess adverse drug reactions
interpret selected laboratory results (as monitoring parameters in therapeutics) of specific disease states
know pharmaceutical care services
do patient counseling in community pharmacy; appreciate the concept of Rational drug therapy.
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals, Classification based on clinical and non- clinical basis, Organization Structure of a Hospital, and Medical staffs involved in the hospital and their functions.
Definition, functions of hospital pharmacy, Organization structure, Location, Layout and staff requirements, and Responsibilities and functions of hospital pharmacists.
Classifications - Excessive pharmacological effects, secondary pharmacological effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions, and pharmacokinetic drug interactions, Methods for detecting
drug interactions, spontaneous case reports and record linkage studies, and Adverse drug reaction reporting and management.
Organization and structure of retail and wholesale drug store, types and design, Legal requirements for establishment and maintenance of a drug store, Dispensing of proprietary products, maintenance of records of retail and wholesale drug store.
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of controlled drugs.
Definition, contents of hospital formulary, Differentiation of hospital formulary and Drug list, preparation and revision, and addition and deletion of drug from hospital formulary.
Need for Therapeutic Drug Monitoring, Factors to be considered during the Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.
Causes of medication non-adherence, pharmacist role in the medication adherence, and monitoring of patient medication adherence.
Need for the patient medication history interview, medication interview forms.
Financial, materials, staff, and infrastructure requirements.
Organization, functions, Policies of the pharmacy and therapeutic committee in including drugs into formulary, inpatient and outpatient prescription, automatic stop order, and emergency drug list preparation.
Drug and Poison information centre, Sources of drug information, Computerised services, and storage and retrieval of information.
Definition of patient counseling; steps involved in patient counseling, and Special cases that require the pharmacist
Role of pharmacist in the education and training program, Internal and external training program, Services to the nursing homes/clinics, Code of ethics for community pharmacy, and Role of pharmacist in the interdepartmental communication and community health education.
Prescribed medication order- interpretation and legal requirements, and Communication skills- communication with prescribers and patients.
Budget preparation and implementation
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart review, clinical review, pharmacist intervention, Ward round participation, Medication history and Pharmaceutical care.
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern.
Introduction and sale of over the counter, and Rational use of common over the counter medications.
Organisation of drug store, types of materials stocked and storage conditions, Purchase and inventory control: principles, purchase procedure, purchase order, procurement and stocking, Economic order quantity, Reorder quantity level, and Methods used for the analysis of the drug expenditure
Description, principles involved, classification, control, identification, role of hospital pharmacist, advisory committee.
Blood chemistry, hematology, and urinalysis
Merchant S.H. and Dr. J.S.Quadry. A textbook of hospital pharmacy, 4th ed. Ahmadabad: B.S. Shah Prakakshan; 2001.
Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of
st
Clinical Pharmacy Practice- essential concepts and skills, 1 ed. Chennai: Orient Longman Private Limited; 2004.
William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger; 1986.
Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society of Health System Pharmacists Inc; 2009.
Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS Publishers & Distributers; 2008.
Therapeutic drug monitoring. ISSN: 0163-4356 Journal of pharmacy practice. ISSN : 0974-8326
American journal of health system pharmacy. ISSN: 1535-2900 (online) Pharmacy times (Monthly magazine)
To understand various approaches for development of novel drug delivery systems. To understand the criteria for selection of drugs and polymers for the development of Novel drug delivery systems, their formulation and evaluation
/microcapsules, microparticles, methods of microencapsulation, applications
Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel Dekker, Inc., New York, 1992.
Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker, Inc., New York, 1992.
Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley Interscience Publication, John Wiley and Sons, Inc, New York. Chichester/Weinheim
N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New Delhi, First edition 1997 (reprint in 2001).
S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances, Vallabh Prakashan, New Delhi, First edition 2002.
Indian Journal of Pharmaceutical Sciences (IPA) Indian Drugs (IDMA)
Journal of Controlled Release (Elsevier Sciences)
Drug Development and Industrial Pharmacy (Marcel & Decker) International Journal of Pharmaceutics (Elsevier Sciences)
A project work shall be compulsory. The project shall be undertaken in any of the areas of Pharmaceutical Science.
The project shall be made under the supervision and guidance of faculty member(s). The candidate shall present a seminar on his/her project work.
Every candidate shall be required to submit the project report in triplicate(typed & bound copy not less than 25 pages). The marks shall be awarded by the project supervisor and one external examiner duly appointed by university.
=======Understand the interaction of matter with electromagnetic radiations and its applications in drug analysis
Understand the chromatographic separation and analysis of drugs.
Perform quantitative & qualitative analysis of drugs using various analytical instruments.
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on absorption spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors-Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications - Spectrophotometric titrations, Single component and multi component analysis
Theory, Concepts of singlet, doublet and triplet electronic states, internal and external conversions, factors affecting fluorescence, quenching, instrumentation and applications
Introduction, fundamental modes of vibrations in poly atomic molecules, sample handling, factors affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell, Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications
Determination of absorption maxima and effect of solvents on absorption maxima of organic compounds
Estimation of dextrose by colorimetry Estimation of sulfanilamide by colorimetry
Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy Assay of paracetamol by UV- Spectrophotometry
Estimation of quinine sulfate by fluorimetry Study of quenching of fluorescence Determination of sodium by flame photometry Determination of potassium by flame photometry
Determination of chlorides and sulphates by nephelo turbidometry Separation of amino acids by paper chromatography
Separation of sugars by thin layer chromatography Separation of plant pigments by column chromatography Demonstration experiment on HPLC
Demonstration experiment on Gas Chromatography
Instrumental Methods of Chemical Analysis by B.K Sharma Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake Organic Chemistry by I. L. Finar
Organic spectroscopy by William Kemp Quantitative Analysis of Drugs by D. C. Garrett
Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi Spectrophotometric identification of Organic Compounds by Silverstein
Know the process of pilot plant and scale up of pharmaceutical dosage forms Understand the process of technology transfer from lab scale to commercial batch Know different Laws and Acts that regulate pharmaceutical industry
Understand the approval process and regulatory requirements for drug products
D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization - practical aspects and problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues
Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php
Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.
appreciate the pharmacy stores management and inventory control
monitor drug therapy of patient through medication chart review and clinical review
obtain medication history interview and counsel the patients identify drug related problems
detect and assess adverse drug reactions
interpret selected laboratory results (as monitoring parameters in therapeutics) of specific disease states
know pharmaceutical care services
do patient counseling in community pharmacy; appreciate the concept of Rational drug therapy.
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals, Classification based on clinical and non- clinical basis, Organization Structure of a Hospital, and Medical staffs involved in the hospital and their functions.
Definition, functions of hospital pharmacy, Organization structure, Location, Layout and staff requirements, and Responsibilities and functions of hospital pharmacists.
Classifications - Excessive pharmacological effects, secondary pharmacological effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions, and pharmacokinetic drug interactions, Methods for detecting
drug interactions, spontaneous case reports and record linkage studies, and Adverse drug reaction reporting and management.
Organization and structure of retail and wholesale drug store, types and design, Legal requirements for establishment and maintenance of a drug store, Dispensing of proprietary products, maintenance of records of retail and wholesale drug store.
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of controlled drugs.
Definition, contents of hospital formulary, Differentiation of hospital formulary and Drug list, preparation and revision, and addition and deletion of drug from hospital formulary.
Need for Therapeutic Drug Monitoring, Factors to be considered during the Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.
Causes of medication non-adherence, pharmacist role in the medication adherence, and monitoring of patient medication adherence.
Need for the patient medication history interview, medication interview forms.
Financial, materials, staff, and infrastructure requirements.
Organization, functions, Policies of the pharmacy and therapeutic committee in including drugs into formulary, inpatient and outpatient prescription, automatic stop order, and emergency drug list preparation.
Drug and Poison information centre, Sources of drug information, Computerised services, and storage and retrieval of information.
Definition of patient counseling; steps involved in patient counseling, and Special cases that require the pharmacist
Role of pharmacist in the education and training program, Internal and external training program, Services to the nursing homes/clinics, Code of ethics for community pharmacy, and Role of pharmacist in the interdepartmental communication and community health education.
Prescribed medication order- interpretation and legal requirements, and Communication skills- communication with prescribers and patients.
Budget preparation and implementation
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart review, clinical review, pharmacist intervention, Ward round participation, Medication history and Pharmaceutical care.
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern.
Introduction and sale of over the counter, and Rational use of common over the counter medications.
Organisation of drug store, types of materials stocked and storage conditions, Purchase and inventory control: principles, purchase procedure, purchase order, procurement and stocking, Economic order quantity, Reorder quantity level, and Methods used for the analysis of the drug expenditure
Description, principles involved, classification, control, identification, role of hospital pharmacist, advisory committee.
Blood chemistry, hematology, and urinalysis
Merchant S.H. and Dr. J.S.Quadry. A textbook of hospital pharmacy, 4th ed. Ahmadabad: B.S. Shah Prakakshan; 2001.
Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of
st
Clinical Pharmacy Practice- essential concepts and skills, 1 ed. Chennai: Orient Longman Private Limited; 2004.
William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger; 1986.
Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society of Health System Pharmacists Inc; 2009.
Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS Publishers & Distributers; 2008.
Therapeutic drug monitoring. ISSN: 0163-4356 Journal of pharmacy practice. ISSN : 0974-8326
American journal of health system pharmacy. ISSN: 1535-2900 (online) Pharmacy times (Monthly magazine)
To understand various approaches for development of novel drug delivery systems. To understand the criteria for selection of drugs and polymers for the development of Novel drug delivery systems, their formulation and evaluation
/microcapsules, microparticles, methods of microencapsulation, applications
Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel Dekker, Inc., New York, 1992.
Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker, Inc., New York, 1992.
Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley Interscience Publication, John Wiley and Sons, Inc, New York. Chichester/Weinheim
N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New Delhi, First edition 1997 (reprint in 2001).
S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances, Vallabh Prakashan, New Delhi, First edition 2002.
Indian Journal of Pharmaceutical Sciences (IPA) Indian Drugs (IDMA)
Journal of Controlled Release (Elsevier Sciences)
Drug Development and Industrial Pharmacy (Marcel & Decker) International Journal of Pharmaceutics (Elsevier Sciences)
A project work shall be compulsory. The project shall be undertaken in any of the areas of Pharmaceutical Science.
The project shall be made under the supervision and guidance of faculty member(s). The candidate shall present a seminar on his/her project work.
Every candidate shall be required to submit the project report in triplicate(typed & bound copy not less than 25 pages). The marks shall be awarded by the project supervisor and one external examiner duly appointed by university.
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