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Final Professional: (Pharmaceutical Quality Management) (

This document discusses topics related to pharmaceutical quality management and testing. It covers methods for determining alcohol content in liquids, assaying alkaloidal drugs, ensuring quality of vaccines through stability testing and potency testing, and various other pharmaceutical determinations and tests like moisture content and ash content. It also discusses standardization of pharmaceuticals according to good manufacturing practices and statistical interpretation of quality control charts during manufacturing processes. The note specifies that practical exams will involve assays of various pharmaceutical preparations and testing for qualities like alcohol content, alkalinity of glass, and moisture content.

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Noman Zaki
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0% found this document useful (0 votes)
98 views

Final Professional: (Pharmaceutical Quality Management) (

This document discusses topics related to pharmaceutical quality management and testing. It covers methods for determining alcohol content in liquids, assaying alkaloidal drugs, ensuring quality of vaccines through stability testing and potency testing, and various other pharmaceutical determinations and tests like moisture content and ash content. It also discusses standardization of pharmaceuticals according to good manufacturing practices and statistical interpretation of quality control charts during manufacturing processes. The note specifies that practical exams will involve assays of various pharmaceutical preparations and testing for qualities like alcohol content, alkalinity of glass, and moisture content.

Uploaded by

Noman Zaki
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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7.

ALCOHOL DETERMINATION: Alcoholometric methods, Problem during distillation of


alcohol, Method for liquids containing less than 30% or more than 30% alcohol and special
treatment before distillation.

8. ALKALOIDAL DRUG ASSAY: Weighing for assay, Extraction of drugs, Maceration,


Percolation, Continuous extraction, Purification of Alkaloids and determination of alkaloids.

9. QUALITY ASSURANCE OF VACCINES: Introduction, Quality measures for stability of


vaccines, potency testing, and post market surveillance of vaccines.

10. MISCELLANEOUS DETERMINATIONS AND TESTS: Determination of weight/ml,


Water/Moisture content, Loss on Drying, Evaluation of Ointments, Ash contents and Alkalinity
of Glass.

11. STANDARDIZATION OF PHARMACEUTICALS: An understanding of quality assurance


system adopted in pharmaceutical industry. Good Manufacturing Practices and Current Good
Manufacturing Practices.

12. STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING


MANUFACTURING PROCESSES:

PHARMACEUTICS-VI (PHARMACEUTICAL QUALITY MANAGEMENT) (Practical)


Paper 9 Marks 100

NOTE: Practical of the subject shall be designed from time to time on the basis of the above mentioned
theoretical topics and availability of the facilities e.g. Assay of various spirits, tinctures, extracts,
syrups and elixirs, Assay of Ointments and suppositories, Assay of tablets and capsules, Test for
alkalinity of glass, Determination of alcohol contents in the Pharmaceutical preparations and Pyrogen
test. Sterility test, Determination of Ash contents, Determination of Moisture contents, Determination
of total solids, Determination of viscosity of syrups, gels etc. Determination of emulsion types (Note:
A minimum of 20 practicals will be performed).

FINAL PROFESSIONAL

PHARMACEUTICAL CHEMISTRY-IV (MEDICINAL CHEMISTRY) (Theory)


Paper 1 Marks 100

NOTE: The topics will be taught with special reference to their Pharmaceutical Applications.

1. INTRODUCTION TO MEDICINAL CHEMISTRY: Chemical constitution and biological


activity: (Receptor, Theory, Structure Activity Relationships (SAR) and Drug Metabolism).

97
Modern concept of rational drug design, pro drug, combinatorial chemistry and computer aided drug
design (CADD) and concept of antisense molecules.

2. DRUG TARGETS AND DRUG DESIGNING:


a) Introduction and types of drug targets

b) Introduction to molecular modeling and computational chemistry

c) Structure based designing

d) Ligand-based designing

e) Various techniques in drug synthesis

3. GENERAL PROPERTIES, CHEMISTRY, BIOLOGICAL ACTION, STRUCTURE


ACTIVITY RELATIONSHIP AND THERAPEUTIC APPLICATIONS OF THE
FOLLOWING:

a. Hormones: Steroidal Hormones (Testosterone, Progesterone, Estrogen, Aldosteron and


Cortisol), Proteinous Hormones (Insulin, Glucagon, Oxytocin and Vassopressin).
b. Anti-neoplasticAgents: Tamoxifen, Fluorouracil, Mercapturine, Methotrexate and
Vincristine.
c. Sedatives and Hypnotics: Benzodiazepines, Barbiturates, Paraldehyde, Glutethimide,
Chloral hydrate, and alcohols.
d. Anaesthetics: Local anaesthetics (Procaine, Lignocaine, Eucaine, Cocaine and Benzocaine),
General anaesthetics (Cyclopropane, Halothane, Nitrous oxide, Chloroform, Thiopental
Sodium, Ketamine, Methohexital, Thioamylal Sodium, Fantanyl Citrate, Tribromo ethanol).
e. Analgesics and Antipyretics: Paracetamol, Salicylic acid analogues, Quinolines derivatives,
Pyrazolone and Pyrazolodiones, N - arylanthranilic acids, Aryl and heteroaryl acetic acid
derivatives.
f. Sulphonamides: Prontosil, sulphanilamide, Sulphapyridine, sulphadimidine,
Sulfamethoxazole, Sulfadiazine and Sulfafurazole.
g. Antimalarials: 4-Aminoquinolines, 8-Aminoquinolines, 9-Amino acridines, Biguanides,
Pyrimidine analogues, Mefloquine and Cinchoha alkaloids.
h. Diuretics: Mercaptomerin, Meralluride, Thiazides, Sprironolac-tone, Theophylline,
Furosemide, Acetazolamiode, Ethacrynic acid and Triameterene.
i. Antitubercular Drugs: Ethambutol, Isonicotinic acid, Hydrazid, Rifampacin, Thioguanine,
Pyrazinamide, cycloserine, Ethunamide, Cytarabine, 5-Flourouracil and Dacarbazine.
j. Antiviral Drugs: Acyclovir, Tromantadine Hydrochloride and Ribavirin.
k. Immunosuppressant Agents: Azathioprine and Cyclosporin.
l. Antibiotics: Penicillins, Cephalosporins, Streptomycin, Chloramphenicol, Tetracyclines,
Kanamycin and Erythromycin.

98
PHARMACEUTICAL CHEMISTRY-IV (MEDICINAL CHEMISTRY) (Practical)
Paper 6 Marks 100

NOTE: Practical of the subject shall be designed from time to time on the basis of the above
mentioned theoretical topics and availability of the facilities e.g. Estimation of functional groups;
Carboxylic, Hydroxy, Amino and Nitro groups; Determination of Molecular weights of Organic
Compounds. Synthesis of Paracetamol, Salicylic Acid, Methyl salicylate, Azobenzene, Benzoic Acid,
5-Hydroxy-1, 3-benzoxazol-2-one, Aspirin, P-nitrosophenol, 3-nitrophthalic acid, Chloro-benzoic
acid. Assay of the Drugs like Sulpha drugs, Aspirin, Paracetamol, Benzyl Penicillin. Inorganic
Preparations (Note: A minimum of 20 practicals will be conducted).

PHARMACY PRACTICE-VI (CLINICAL PHARMACY-II) (Theory)


Paper 2 Marks 100

1. RATIONAL USE OF DRUGS: Rational Prescribing, Rational Dispensing, Problems of Irrational


Drug Use, Learning about drug use problem, Sampling to study drug use, Indicators of drug use.

2. INTRODUCTION TO ESSENTIAL DRUGS: Criteria for selection, Usage and Advantages.


Development of EDL.

3. DRUG UTILZATION EVALUATION & DRUG UTILIZATIONREVIEW (DUE/DUR):


Development of protocol of use of few very low therapeutic index drug groups like Steroids,
Vancomycin and Cimetidine.

4. CLINICAL PHARMACOKINETICS: Therapeutic Drug Monitoring of Digoxin, Theophyline,


Gentamycin, Lithium, Phenytoin, Cabamazepine, Phenobarbitone, Valproic Acid, Cyclosporins
and Vancomycin.

5. PHARMACEUTICAL CARE, ITS SCOPE, MANAGEMENT AND APPLICATION OF


CARE PLAN:

6. CLINICAL THERAPEUTICS: General Strategy: Terminology of Disease. Management and


Treatment. Drug Selection.

7. CLINICAL TOXICOLOGY:

(a) General information. Role of pharmacist in treatment of poisoning and general


management of poisoning & over dosage. Role and Status of Poison Control Centre.
(b) Antidotes and their mechanism of action.
8. SAFE INTRAVENOUS THERAPY & HAZARDS OF IV THERAPY

9. NON-COMPLIANCE: Definition, introduction and importance, Extent of non-compliance,


Methods of assessment, Reasons for non-compliance, Strategies for improving compliance.
99
10. DISEASE MANAGEMENT:

Unit V: Central nervous system unit (Stroke, Epilepsy, Psychosis)


Unit VI: Infectious diseases (Meningitis, tuberculosis, dermatological infections, Rabies,
Urinary track infection, Malaria fever, Typhoid fever, Fungal infections of skin, AIDS,
Dengue fever, Common Cold, Pharyngitis & Tonsillitis, Conjunctivitis)
Unit VII: Endocrinology Unit (Diabetes Mellitus, Hyper/Hypo-thyroidism, pituitary gland
non-malignant disorders)
Unit VIII: Oncology Unit (Types of tumors, Brief introduction to oncological diseases e.g.
prostate cancer, breast cancer, lungs cancer )
Unit IX: Nephrology Unit (Renal failure, nephrotic syndrom)
Unit X: Hematology Unit (Bleeding disorders/coagulopathies/clotting disorders e.g.
thrombocytopenia, hemophilia, Vit. K deficiency, Anemia).

PHARMACY PRACTICE-VI (CLINICAL PHARMACY-II) (Practical)


Paper 7 Marks 100
Clerkship in the Clinical Setting. A project Related to Clinical Pharmacy Practices will be
completed by the students and will be evaluated by the external examiner.

Student are required to take/present verbal presentation, communication, written and


problem-solving skills, critical analysis of data and provision of care through a weekly
conference and projects

PHARMACEUTICS-VII (PHARMACEUTICAL TECHNOLOGY) (Theory)


Paper 3 Marks 100

1. PRINCIPLES OF PHARMACEUTICAL FORMULATION AND DOSAGE FORM DESIGN:


Need for dosage form; Pre-formulation Studies; Product Formulation.

2. ADVANCED GRANULATION TECHNOLOGY (DESIGN & PRACTICE):


Spray Drying Granulation Technology; Roller Compaction Technology; Extrusion/Spheronization as
a Granulation Technique; Single-Pot Processing Granulation Technology: Rapid Release
Granulation Technique; Particle Coating by Centrifugation Granulation Technology.

3. POLYMERS USED IN DRUG DELIVERY SYSTEMS:

4. NOVEL DRUG DELIVERY SYSTEM (DDS):


Sustained/ Controlled Release Drug Delivery System
i. Microencapsulation technique
Coacervation
Solvent evaporation
Interfacial polymerization
Spray drying
ii. Developmental aspects of Matrix and Reservoir Systems
100
5. NOVEL GIT DRUG DELIVERY SYSTEM (DDS):
Oral Osmotic Pumps
Ion-Exchange Controlled DDS
pH-Controlled DDS
Bio/mucoadhesive DDS
Floating DDS

6. DRUG CARRIER SYSTEM:


Liposomes
Niosomes

7. TARGETED DRUG DELIVERY SYSTEM:


Active Drug Delivery System
Passive Drug Delivery System

8. PHARMACEUTICAL BIOTECHNOLOGY:
a. Introduction to Biotechnology: Genetics/Genomics, Proteomics, Biomolecular target
Identification, Pharmacogenomics, Gene therapy and Nucleic acid therapeutics.
b. Techniques Used in Pharmaceutical biotechnology: PCR, DNA Sequencing, Affinity
Protein Purification.
c. Fundamentals of Genetic Engineering and its Application in Medicine
d. Pharmaceutical Recombinant therapeutic Proteins, Growth factors, Therapeutic
antibodies, High-throughput screening of putative therapeutic compounds.
e. Biotechnological aspects in the product development
f. Principle, Synthesis and Application of Monoclonal Antibodies
g. Immobilized Enzymes and their application in Medicine

PHARMACEUTICS-VII (PHARMACEUTICAL TECHNOLOGY) (Practical)


Paper 8 Marks 100

NOTE: Practical of the subject shall be designed from time to time on the basis of the above mentioned
theoretical topics and availability of the requirements, e.g.
Various techniques to develop the formulation,
Granulation technology,
Study of drug delivery systems,
Biotechnological aspect of product development,
In-vitro Quality Control of various dosage forms.
Microbial assay,
Particle size analysis using various methods,
Stability studies of Pharmaceuticals,
Coating of particles and to prepare,
Examine and control specifications of packaging materials.
101
PHARMACY PRACTICE-VII (FORENSIC PHARMACY) (Theory)
Paper 4 Marks 100

1. GENERAL INTRODUCTION: Forensic Pharmacy & Forensic Pharmacist, History of Drug


Legislation and Pharmacy Profession in Pakistan, National Health Policy, National Drug Policy,
Essential Drugs, Prescription handling at Retail level and Record keeping, Drug Control
Administration at Federal and Provincial level.

2. ROLE OF FORENSIC PHARMACIST: Forensic drug Measurement, Post-mortem


redistribution (PMR), Medication errors, prescription forgery, product tampering, Insurance
fraud, Use of drugs or alcohol in car accidents or violent actions, Legal and illegal
pharmaceutical evidence in criminal investigations, use of abused drugs in the workplace,
professional malpractice, quackery and health care fraud.

3. PHARMACEUTICAL ETHICS: Patents and Generics, Ethics in Sale, Ethics in Industry,


Ethics in Research.

4. STUDY OF DRUG LAWS:

a. The Drugs Act 1976 and rules framed there under.


b. Provincial Drug Rules (Respective Drug Rules will be taught in the relevant province).
c. Advertisement rules.
d. Other Related rules and Legal aspects.

5. THE PHARMACY ACT 1967:

6. CONTROL OF NARCOTICS SUBSTANCES ACT 1997: Laws relating to Narcotic drugs


and psychotropic substances.

7. THE POISONS ACT 1919:

8. THE FACTORIES ACT 934:

9. SHOPS AND ESTABLISHMENTS ORDINANCE 1969 WITH RULES:

PHRAMACY PRACTICE-VIII (PHARMACEUTICAL MANAGEMENT & MARKETING) (Theory)


Paper 5 Marks 100

1. MANAGEMENT & MARKETING:


a. Nature and Principles of Management:
b. Types and Functions of Managers:
c. Planning: Purpose and types of Planning, Steps in Planning
d. Organizing:
e. Management Control Systems: Purpose, Steps in the Control Process, Forms of operations
control. Requirements for adequate control, Critical control points and standards.
102
f. Motivation:
g. Innovation and Creativity:
h. Principals of Marketing:
i. Product Management:
j. Marketing Research:

2. PRODUCTION MANAGEMENT: Material Management, Planning of production, Batch record


maintenance.

3. MARKETING MANAGEMENT:
a. Ethical consideration of Pharmaceutical Marketing
b. Difference between Pharmaceutical Marketing and Consumer Marketing
c. Major stakeholders within pharmaceutical market environment.
d. Marketing Research (Process and Methodology)
e. Market Analysis Techniques 3Cs (Customer analysis, Company analysis, competitors analysis)
f. Evaluating the marketing performance (audit tools and audit process)
g. Designing sales force structure, sales force size and sales quota
h. Marketing channels, Promotion and Advertising and Salesmanship.

4. SALES MANAGEMENT: Personnel, Buying, Receiving, Pricing, Sales promotion and Customer
Services.

5. BUSINESS DEVELOPMENT MANAGEMENT: General principles, strategies, short and long


term planning and objectives.

6. BUSINESS COMMUNICATION: Importance and benefits of business communication,

7. STRATEGIES FOR SUCCESSFUL BUSINESS AND GLOBAL MEETINGS: Background


information on groups, purpose and kinds of meetings, solving problems in meetings, leadership

NOTE: Upon completion of recognized Pharm.D. degree, a pharmacy graduate is required to undergo
residency based training for a period of 1 year in any area; at public or private Hospital,
Pharmaceutical Industry, Community Pharmacy, Pharmaceutical Marketing, Research & Development
and Public health recognized by the Pharmacy Council of Pakistan. The objective of the residency is to
undergo a planned training on aspects of pharmacy practice under the supervision of a registered
pharmacist.

103

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