MPharm in Pharmaceutical Technology & Biopharmaceutics (MPharm PTB)

Overview

Curriculum


Duration:
2 years, Total credit hours:  36, Semester: 4

 Course Contents:

 Thesis :

Type of Courses

Number of Courses

Credit Hours

Core Courses

3

9

Specialized course/ Track courses

4

12

Elective/Optional Courses/Directed studies

3

9

Dissertation

1

4

Seminar

1

1

Viva-voce

1

1

Total

13

36

 
Non-Thesis :

Type of Courses

Number of Courses

Credit Hours

Core Courses

3

9

Specialized course/ Track courses

4

12

Elective/Optional Courses/Directed studies

4

12

Assignment

1

1

Seminar

1

1

Viva-voce

1

1

Total

13

36

 

Distribution of Courses:

Core Courses (compulsory for all students)

Course code

Course Title

Total Credits

PHR5001

Advanced Pharmacology I

3

PHR5002

Advanced Pharmaceutical analysis

3

PHR5003

Advanced Statistics in Pharmaceutical Sciences

3

 

Specialized courses/ Track courses

PHR5021

Advanced Pharmaceutical Technology

3

PHR5022

Advanced Pharmaceutics

3

PHR5023

Advanced Biopharmaceutics & Pharmacokinetics

3

PHR5209

Pharmaceutical Industrial Management

3

 

Elective Courses: Any three (Thesis) and four (Non-Thesis) courses

PHR5201

Drug Design

3

PHR5108

Drug Regulatory Affairs

3

PHR5208

Quality control and Quality Assurance

3

PHR5101

Pharmaceutical Marketing and Brand Management

3

PHR5106

Pharmaceutical Biotechnology

3

 

PHR5110

Dissertation (Thesis)

4

PHR5113

Assignment (Non-Thesis)

1

PHR5111

Seminar

1

PHR5112

Viva voice

1

 

 

Semester-wise Distribution of Courses

Major in Pharmaceutical Technology and Biopharmaceutics

Semester-I:      

Type of Courses

Course Code

Course Titles

Credits

Core

PHR5001

Advanced Pharmacology I

3

Core

PHR5002

Advanced Pharmaceutical analysis

3

Core

PHR5003

Advanced Statistics in Pharmaceutical Sciences

3

Total

 

 

9

 

Semester-II:                                                                                            

Type of Courses

Course Code

Course Titles

Credits

Specialized

PHR5021

Pharmaceutical Technology

3

Specialized

PHR5022

Advanced Pharmaceutics

3

Specialized

PHR5023

Advanced Biopharmaceutics & Pharmacokinetics

3

Total

 

 

9

 

Semester-III:                                                                                           

Type of Courses

Course Code

Course Titles

Credits

Specialized

PHR5209

Pharmaceutical Industrial Management 

3

Elective

 

Elective II

3

Elective

 

Elective II

3

Total

 

 

9

 

Semester-IV:                                                                                           

Type of Courses

Course Code

Course Titles

Credits

Elective

 

Elective III

3

Dissertation

PHR5110

Dissertation

4

Seminar

PHR5111

Seminar

1

Viva Voce

PHR5112

Viva Voce

1

Total

 

 

9

Course Description


PHR5001

Advanced Pharmacology-I

  1. Care, handling and breeding techniques of laboratory animals, Regulations for Laboratory animal care and ethical requirements. Knowledge of the CPCSEA Proforma for performing experiments on animals. Alternative to animal studies.
  2. Organization of preclinical screening programme and safety assessment tests.
  3. Preclinical evaluation of following categories of drugs.

i) Sedatives, hypnotics, anxiolytics, antidepressants, antipsychotics, nootropics,
 antiparkinsonian agents, analgesics, antipyretics.

ii) Anti-inflammatory agents, anticonvulsants, local aneasthetics, CNS stimulants,
iii) Cardiac glycosides, antiarrhythmic, antihypertensive, antianginal, manti-
     atherosclerotic,

iv) Antiulcer agents, Laxatives, Bronchodilators, antitussives,
v)  Diuretics,
vi) Histamine antagonists.
vii)Muscle relaxants, Anticholinesterases, anticholinergics, adrenolytics.
viii)Hypoglycemics, antifertility agents, androgens.
ix)Anti-thyroid agents, Dermatological agents, Antitumor agents.

x)Anthelmintics, Antimalarials, Antileprotics.

 

  4. In vitro testing of drugs. Animal cell lines and their uses. Limitations of in vitro
      testing of drugs.

Recommended Books:

  1. Perry, W. L. M. Pharmacological Experiments on Isolated preparations (E & S Livingstone, London).
  2. Jaju, B. P. Pharmacology Practical Exercise book (Jaypee Brothers, New Delhi).
  3. Burn J. H. Practical Pharmacology (blackwell Scientific Co. oxford).
  4. Lawarence, D. R. & Bacharach, A. L.: E valution of Drug Activities: Pharmacometrics (Academic press, London).
  5. Turner R. A.: Screening Methods in Pharmacology (Academic Press, London).
  6. Thompson E. B. Drug bioscreening VCH New York.
  7. Vogel H. G. and Vogel W. H. Drug Discovery and Evaluation Pharmacological Assays Springer.

 

PHR5002

Advanced Pharmaceutical Analysis

1. Spectroscopic Methods – Introduction application and Structure Elucidation using UV, IR, NMR, Mass Spectroscopy with examples

2. Separation Techniques – Theory, instrumentation, Applications of GLC, HPLC, HPTLC, Chiral Chromatography, lon Pair Chromatography & Capillary Electrophoresis.

3. Thermal Analysis – Theory, Instrumentation and Applications of Thermogravimetric Analysis, Differential Thermal Analysis, Differential Scanning Calorimeter.

4. Immunochemical Techniques – Immunoelectrophoresis, Immunoprecipitation, ELISA, Radioimmuno assays.

5. Introduction to Quality Assurance Techniques – Validation of equipments, processes, products, etc.

Recommended Books:
1. Pharmaceutical Chemistry. L.G. Chatten.
2. Text book of Pharmaceutical Analysis. K. A. Connors.
3. Pharmaceutical Drug Analysis. Ashutosh.
4. Elementary Organic Spectroscopy. Y. R. Sharma.

 

PHR5003

Advanced Statistics in Pharmaceutical Sciences

  1. Statistics and its application. Variables and Attributes.
  2. Classification and tabulation of data. Populations and samples. Frequency distributions. Graphical presentation of data.
  3. Describing and summarizing data: statistical averages & measures of dispersion.  probability andprobability distributions.
  4. Hypothesis testing: concepts, types, p-value.
  5. Test of significance: parametric tests (t-test, One way ANOVA, multiple comparison tests (Bonferoni, Duncan, Dunnet, Tukey), repeated measure ANOVA, Two-way ANOVA; Non-parametric tests: Mann-whiteney, Wilcoxon rank test, Kruskal-Wallis test, multiple comparison tests (Tukey), Friedman's test. Regression (simple linear & nonparametric regression) and correlation (simple & rank correlation), Chi-square & odds ratio. Biostatistics for clinical trials.
  6. Study design & types of study. Sampling & sample size determination
  7. Statistical test for bioequivalence
  8. Analysis of data using statistical package (eg SPSS, SAS etc).

Recommended Books:

1. Pharmaceutical Statistics. Sanford Bolton. Marcel Dekker, Inc.

2. Medical & Pharmaceutical Statistics. Dr JMA Hannan. Sangbed Publishers

3. Biostatistics: A Foundation for Analysis in Health Sciences. Wayne W. Daniel

 

PHR5021

Advanced Pharmaceutical Technology

1. Advanced Tablet Technology:

A. Manufacturing of tablets by wet granulation, dry granulation & direct compression. Granulation of powders for tableting. Advantages and disadvantages of different processes, processes and machineries used in tablet manufacturing

B. Physics of tablet compression, different stages of tablet compression, effect of compression force on tablet properties, strength of tablet, factors affecting the strength of tablet, mechanism of bonding to tablets, problems associated with large scale manufacturing of tablet.

2. Advanced drug Delivery Systems Transdermal drug delivery system, mucosal drug delivery system, nasal drug delivery system, ocular drug delivery system, intrauterine drug delivery system, lliposomes and nanoparticles drug delivery system, biodegradable drug delivery system, hydrogel based drug delivery system, drug delivery to the lungs, metered dose inhalers and dry powder inhalers.

3. Pilot Plant Scale-Up TechniquesPrimary function of the pharmaceutical pilot plant, factors to be considered during development, reporting responsibilities, personnel requirements, space requirements, review of the formula, raw materials, relevant processing equipments, production rates, process evaluation, master manufacturing procedures, GMP considerations, pilot plant design for tablet development.

4. Biotechnology Preparations/ Formulation of Biotech Products

Definitions, historical use and applications, composition, preparation, physicochemical considerations, short study of current biotech products e.g. hematopoietic growth factors, interlukins and interferons, insulin, growth hormones, vaccines, monoclonal antibody-based pharmaceuticals, recombinant tissue type plasminogen, recombinant human deoxyribonuclease, follicle stimulating hormone(FSH), quality control, storage and stability of biotech products.  

Recommended books:

  1. Remington: The Science and Practice of Pharmaceutical Sciences
  2. Dispensing of Pharmaceutical Students – Cooper and Gunn
  3. Dispensing of Medication
  4. Bentley’s Textbook of Pharmaceutics
  5. An Introduction to Pharmaceutical Formulations – Fishburn
  6. Pharmaceutical Dosage Forms – Ansel
  7. Pharmaceutics and Pharmacy Practice – Banker and Chalmers
  8. The Art, Science and Technology of Pharmaceutical Compounding – Loyd V. Allen Jr.
  9. Theory and practice of Industrial Pharmacy – Lachmann
  10. American Pharmacy- Sprowl
  11. Pharmaceutics – Aulton
  12. Trgeted and controlled Drug Delivery, Novel.

 

PHR5022

Advanced Pharmaceutics

1. Solids :
Particle characterisation by size, shape and surface of individual particle and for contacted article. Handling of solids, pharmaceutical granulation, compression and compaction properties of binary mixtures, lubricant sensitivity, characterisation of granules and compacts.

2. Dissolution :
Theory of dissolution, concept of drug release. Dissolution test apparatus: different designs, factors affecting dissolution rate. Dissolution of different dosage forms: solids, suspensions, topicals, suppositories and controlled release systems. Enhancement of dissolution rate.

3. Surfactant System :

Phase behaviour of surfactant in binary and ternary systems. Factors affecting phase behaviour; Micellization; micelle structure, shape, size factors affecting CMC and micelle size, thermodynamics and kinetics of micelle formation. Pharmaceutical aspects of Solubilization, Solubilization in non-aqueous system, interactions with polymers and oppositely charged species. Hydrotrophy in pharmaceuticals, surfactants in emulsions and suspensions. Biological implications of surfactants; Effect on: dissolution of drugs, permeability of membranes, drug absorption, antibacterial activity. Cyclodextrin inclusion complexes and cosolvents.

4. Polymer science :
Types and applications of polymers, polymerization reactions, methods of polymerization and characterization of polymers, thermodynamics of polymer solutions.

5. Solid dispersions :
Types, methods of preparation, selection of carrier, characterization and applications.

6. Stability studies :

Kinetics activation energy calculations, accelerated stability studies, factors responsible for destabilization of pharmaceutical products and techniques to improve, shelf life calculations. Physical testing of solution, suspension, emulsion, aerosol, powder, tablet and sustained release products.

 

PHR5023

Advanced Biopharmaceutics and Pharmacokinetics

1. Clinical pharmacokinetics and its importance:
    Basic concept of elimination half-life, elimination rate constant, clearance, extraction
    rate, area under the curve, protein binding drugs and estimation of biochemical
    parameter from plasma and urine data.

2. Distribution of drugs :-

A. Factors affecting distribution of drugs: Tissue permeability of drugs, 
    Physicochemical properties of drugs, Physiological barriers to diffusion of drugs.
    Organ / Tissue size and perfusion rate. Binding of drugs to blood components
    and tissue. Factors affecting it.  Miscellaneous factors ( Age, Pregnancy, Obesity
    etc). Volume of distribution

B. Clinical concepts and kinetics of physiological parameters of distribution.

3. Elimination of drug: Concept of clearance, Hepatic metabolism: chemical pathways
    and factors affecting it, Renal excretion: principle processes and factors affecting it,
    Non renal excretion, Concepts and kinetics of physiological parameters of
    elimination

4. Bioavailability:

A. Objective of bioavailability studies, determination bioavailability parameters of bioavailability rate of absorption extent of absorption, relative bioavailability, determination of AUC (using planimeter, counting squares trapezoidal rule and cutting and weighing studies)

B. Drug dissolution rate and bioavailability, Theories of dissolution in-vitro drug dissolution testing models invitro - invivo correlation

C. Invitro and insitu absorption studies, Various Invitro & insitu models – selection of animals Correlation between invitro & invivo studies.

5. Non linear Pharmacokinetics: Saturable enzymatic elimination process, drug
    elimination by capacity limited pharmacokinetics, mixed drug elimination, time  
    dependent pharmacokinetics, bioavailability of drug that follow non linear 
    pharmacokinetics, non linear pharmacokinetics due to protein binding (e.g.
    phenytoin)

6. MRT and Statistical moment analysis

7. Pharmacokinetics and pharmacologic response

8. Therapeutic Drug Monitoring

A. Introduction to therapeutic drug monitoring: definition & introduction, indication 
    for tdm & clinical applications, monitoring plasma drug levels, role of clinical
    pharmacist in tdm.

B. Techniques used in tdm, physical methods hplc, hptlc, gc, immuno assays. Ria,
    elisa, emith, niia

C. Importance of tdm with reference to adverse drug reaction

D. Variation of clinical laboratory tests due to drugs tests: Serum creatinine, blood
     urea, nitrogen, plasma, glucose, creatine kinase, phosphatase, amylase,
     bilirubin, serum proteins, globulines, complete blood count & differential blood
     count

E. Tdm of specific drugs clinical pharmacokinetics, general guidelines, sample 
    collection, time of sample collection, clinical comments, clinical monitoring
    parameters, usual dosing parameters, common toxicities, adverse drug
    reactions & drug interactions, techniques used for estimation, importance of
    Digoxin, Lithium, Phenobarbitone, Gentamicin, Theophylline 8. Carbamazepine,
    Lidocaine, Phenytoin, Valproic acid.

Recommended Books:

  1. Clinical Pharmacokinetics - concept & application - Malcolm Rowland & Thomas N. Tozer, Lea & Febiger book.
  2. Applied Biopharmaceutics & Pharmacokinetics – Leon Shargel.
  3. Biopharmaceutics & P'cokinetics - Milo Gibaldi , Lea & Febiger book publication
  4. Biopharmaceutics & P'cokinetics - an introduction - Robert E. Notary.
  5. Biopharmaceutics - Swarbrick, Lea & Febiger book publication
  6. Remington's pharmaceutical sciences
  7. Pharmacokinetics - Milo Gibaldi & Donald Perrier
  8. Biopharmaceutics & Pharmacokinetics. A treatise - D. M. Brahmankar S B. Jasiwal
  9. Biopharmaceutics & Pharmacokinetics - P. L. Madan
  10. Introduction to Biopharmaceutics. - G.P. -Shriwastav
  11. Handbook of clinical p'cokinetics- Gibaldi & Pancot

 

PHR5101

Pharmaceutical Marketing and Brand Management

  1. Introduction: This course discusses various aspects of essential marketing operations in a pharmaceutical company.
  2. Pricing of drugs: Competitive strategies of pricing; Pricing methods.
  3. Market Promotion: Approaches; Developing a promotional plan; Executing the program; Steps in implementation; Advertising of drugs; Direct mail; Personal selling; Miscellaneous promotion; Limiting factors; Evaluation. Advertising: Classification; Primary and selective demand; Strategy; Appraising the opportunity; Media planning; Measuring effectiveness.  Market demand and forecasting: Understanding market demand; Anatomy of a market; Patterns; Forecasting and planning; Using multiple forecasting methods. This also includes pricing policy; main factors, types, mathematical methods evolutions. 
  4. Pharmaceutical Brand Management

Defining brand management, Brand management responsibilities, Brand management across the product life cycle, Current best practices in brand management, Brand analysis and research, Contribution of marketing research to product branding, Market analysis and segmentation for pharmaceutical branding.

Recommended Books:

  1. Management: A global perspective by Weirich, Heinz & Koontz
  2. Principles and Methods of Pharmacy Management by H.A. Smith
  3. Marketing Management by Philip Kotler & Garry Armstrong
  4. Basic Principles of Marketing by Jeorge R. Terry
  5. Macroeconomic Analysis by Shappiro

 

PHR5106

Pharmaceutical Biotechnology

  1. Development of Industrial Fermentation Processes : Screening, detection and assay of fermentatio
  2. Industrial Microorganisms : Source, characteristics, growth and genetics.
  3. n products, stick cultures, fermentation media, inoculum preparation, scale up of fermentations, increasing product yields, fermentation economics.
  4. Industrial Fermentor : Batch and continuous operation, requirements and design of Fermentor, control mechanisms for temperature, pH and foam. Sterilization of fermentation equipment. Tank agitators, spargers, heating and cooling equipment. Materials for construction.
  5. Typical Fermentation Processes: Antibiotic fermentation: Properties, Biosynthesis and Fermentation of Antibacterial antibiotics –Penicillin, tetracyclines, aminoglycosides,
  6. chloramphenicol and macrolides. Antifugals – Griseofulvin. Antiviral – Bacitracin, hamycin. Antibiotic Production by immobilized living cells. Enzyme Fermentation: Amylases, Proteolytic enzymes. Other Fermentation : Acetonebutanol, citric acid, glycerol, industrial alcohol, yeast and Vitamins.
  7. Downstream Processing : Unit operations in downstream processing
       A. Harvesting: Sedimentation, centrifugation, filtration.
       B. Cell Disintegration: Nonmechanical method such as wet milling, high pressure 
           homogenization, treatment extrusion and sonification.
       C. Clarification of crude extract.
       D. Product Entrichment: precipitation, ultrafiltration, extraction.
       E. Chromatography: Gel filtration, ion exchange, hydrophobic and affinity type.

  8. Biotechnology product formulation, stability studies, quality control, packaging. 

Recommended Books :

  1. E.J.Vandamme; Biotechnology of Industrial Antibiotics; Marcel and Dekker.
  2. H.J.Rahm and G.Reed : Biotechnology : Verlag Chaemie.
  3. L.E.Casida : Industrial Microbiology : Wiley Eastern Limited.
  4. G.REED : Prescott and Dunn’s Industrial Microbiology : The AVI Publications.
  5. Petal : Industrial Microbiology.

 

PHR5108

Drug Regulatory Affairs

This course focuses on the concepts, working techniques and tools needed to examine and register pharmaceuticals for human use at home and abroad. Accepted standards of harmonization and technical requirements for the registration of pharmaceuticals for human use; Approval process, format and registration of pharmaceuticals in Bangladesh. Drug Regulatory Affairs and Intellectual Property Rights, Documentation and Maintenance of records, Environment protection Act.

Professional characteristic and ethical norms, relationship of trust, ethical considerations during pharmacy practice, deficiencies of self regulation, adherence of self regulation.

The pharmacist’s code of ethics. Government health and drug policies.

This course reviews the recent global developments and trends in all the necessary steps of manufacturing quality pharmaceuticals.

Recommended Books:

    1. Remington's Pharmaceutical Sciences.
    2. Guarino, R.A., New Drug Approval Process, Marcel Dekker, New York.
    3. Federal Food, Drug & Cosmetic Act
    4. Phillip W. Grubb, Patents for Chemicals, Pharmaceuticals and Biotechnology

 

PHR5201

Drug Design

  1. A general study of co-relation of physico-chemical properties, and stereochemistry and drug action. Isosterism and bio-isosterism as guides to structural variations, metabolite, antagonism and theory of drug action.
  2. An overall treatment of the approaches to drug design, including the method of variation, study of the use of biochemical and physiological information in evolving new drugs and basis of design.
  3. The basis of drugs design and recent advances: Antihypertensive agents, Antineoplastic agents, Anti-AIDS agents, Antipsychotic agents, GABA-nergic agonists, Chemistry of Beta-lactam antibiotics,
  4. Drug design based on antagonism and enzyme inhibition.
  5. Molecular modelling in Drug Design: Molecular mechanics, Quantum Mechanics, Known receptor sites, Defination, Characterisation of sites, design of ligands, manually assisted three dimentional databases & calculation of affinity, Unknown receptor sites, Searching for similarity, Pharmacophore models, molecular comparisons, finding common patterns.
  6. Approaches to the rational Design of Enzyme Inhibitors: Introduction, enzyme inhibitors in medicine, enzyme inhibitors in basic research, Rational Design of Non covalently & covalently binding Enzyme inhibitors, Rapid reversible inhibitors, slow & tight binding inhibitors, transistion state analogs, multisubstrate inhibitors.

Recommended Books:

  1. Ariens – drug design Vol. – II.
  2. Annual Reports in medicinal chemistry (Academic press Inc.)
  3. Smith - William – Introduction to the principles of drug design.
  4. Woodridge – Progress in pharmaceutical Research.
  5. Medicinal Chemistry – Monographs series (Academic Press).
  6. Burgers - Medicinal Chemistry & Drug Discovery

 

PHR 5209

Pharmaceutical Industrial Management

  1. Pilot plant scale – up pilot plant design : tablets, capsules, liquid orals. Parenterals, and semisolid preparations. Basic requirements for design of product, facility, equipment selection.
  2. Personnel, Pharmaceutical process validation for various products.
  3. Quality Assurance: GMP considerations, quality assurance and process control. Total quality management and productivity. ISO 9000 Salient features.
  4. Optimization Techniques: Optimization parameters, classical optimiza-tion, statistical design and applied optimization methods.
  5. Production Planning: Plant site selection, layout and organization of pharmaceutical industrial. Vendor development capacity (plant, machine, human resources) assessment of production rate changes, inventory management costing of product and cost controls, planning product mix
  6. Machinery Engineering : Introduction to mechanical, electrical and electronic parts of pharmaceutical machinery, equipments. Material handing for various pharmaceutical products.
  7. Safety : Industrial hazards due to fire, accident, mechanical and electrical equipment, chemical and pharmaceuticals, monitoring and preventive system.
  8. Effluent Testing and Treatment : Pharmaceutical industry.
  9. Automation : Flexible manufacturing system. Computer control systems: data acquizition, distribution control and centralized control system. Typical models for solid and liquid manufacturing.

Recommended Books :

  1. P.R.Watt:Tablet machine instruments in pharmaceuticals; John Wiely and Sons.
  2. B.Rothery: ISO 14000 and ISO 9000; Gower.
  3. G.C.Cole: Pharmaceutical production facilities, design and application: Taylor and Francis.
  4. J.R.Berry and R.A.Nashi Pharmaceutical process validation: Marcel Dekker.
  5. S.Bolton: Pharmaceutical statistical: Marcel Dekker.
  6. S.H.Will and J.R.Stoker; Good Manufacturing Practices for Pharmaceutical : Marcel Dekker.
  7. R.F.Brewer: Design of Expreiments for process improvement and quality Assurance: Narosa.
  8. M. Pharm Pg No. Shivaji University, Kolhapur 71
  9. D.H.Stamatis: Understanding ISO 9000 and implementing the basics to quality: Marcel Dekker.
  10. P.Gilson. G.Green halgh and K.Kerr: Manufacturing management: Chapman and Hall.
  11. J.F.Despautz: Automation and validation of information in Pharmaceutical processing: Marcel Dekker.
  12. S.N.Katju’s; Law and drugs: Law publishers(I) Pvt. Ltd.


PHR5208

Quality Control and Quality Assurance

  1. Concept of Chemical. Biochemical and Clinical equivalence methods and their appraisal, to study identity. purity and content uniformity of drugs.
  2. Quality Control—Importance of particulate matter, sampling techniques — analytical, biological and clinical testing, fill quantity.
  3. Study of stability, bioavailability of products, factors affecting the same.
  4. Quality Control, evaluation of package performance. Shelf life of package articles—labels and labeling.Applications of Statistical methods for assessment of reliability and reproducibility of results: random selection of samples for testing.
  5. Inprocess quality control for manufacturing reliability.
  6. Development of drug information profiles.
  7. Various pharmacopoeias of different countries and their gross knowledge.
  8. Good Manufacturing Practices: Interpretations of current good manufacturing regulations, Auditing function in the Total control of Quality, Process validation and control of components, containers & closures, Production and process controls, Packaging & Labeling control, Laboratory controls, Records and reports, Returned and Salvaged Drug products,  Repacking and Re-labeling, Recalls, Problem Analysis and Corrective action Report,  Quality control of Biological -international Biological standards, Safety testing, of Pharmaceutical Quality control of Antibiotics, Evaluation of sustained release products.

Recommended Books:

  1. S. Weinberg, Good laboratory practice Regulations, Marcel and Dekker.
  2. J. Swarbrick Boylan, encyclopedia of pharmaceutical technology, Marcel and Dekker.
  3. J.R. Berry and R.A. Nash, Pharmaceutical process validation. Marcel and Dekker.
  4. S.H. Will and J.R. Stoker, good manufacturing Practices for Pharmaceutics Marcel Dekker.
  5. R.F. Brewer, Design of experiments for process improvement and quality Assurance Narrosa.
  6. B. Othery. ISO 14000 and ISO 9000 Gower.
  7. D.H. Stamatis, Understanding ISO 9000 and implementing the basics to quality; Marcel Dekker.
  8. Lachman et.al. Theory and Practice of Industrial Pharmacy, Varghese Publication, New Delhi.
  9. Shah , Paradkar et.al , Introduction to biostatistics and computer science, Nirali Prakashan, Pune.
  10. Mahajan B.K. Methods in biostastics for medical students and research students. Jaypee Brothers Medical Publishers , New Delhi
  11.  11. Smith, Chemical stability, MacGraw Hill publication, New Delhi.

Course Outline

Undergrad