Course Curriculum

MPharm
in
Pharmaceutical Technology & Biopharmaceutics
Program

Department of Pharmacy
NORTH SOUTH UNIVERSITY
Bashundhara, Dhaka-1229
 Annexure II

Curriculum of
M Pharm in Pharmaceutical Technology & Biopharmaceutics

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

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 Distribution of Courses:
Core Courses (compulsory for all students)
Course Course Title Total Credits
code
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 & 3
Pharmacokinetics
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 3
Management
PHR5106 Pharmaceutical Biotechnology 3

PHR5110 Dissertation (Thesis) 4

PHR5113 Assignment (Non-Thesis) 1
PHR5111 Seminar 1
PHR5112 Viva voice 1

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 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 Advanced Pharmaceutics 3
PHR5022
Specialized Advanced Biopharmaceutics & 3
PHR5023
Pharmacokinetics
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
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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.

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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.

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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 Techniques

Primary 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.
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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

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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.

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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

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1. Industrial Microorganisms : Source, characteristics, growth and genetics.
2. Development of Industrial Fermentation Processes : Screening, detection and assay of
fermentation products, stick cultures, fermentation media, inoculum preparation, scale up of
fermentations, increasing product yields, fermentation economics.
3. 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.
4. Typical Fermentation Processes: Antibiotic fermentation: Properties, Biosynthesis and
Fermentation of Antibacterial antibiotics –Penicillin, tetracyclines, aminoglycosides,
5. 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.
6. 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.

7. 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.
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 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

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5. Pilot plant scale – up pilot plant design : tablets, capsules, liquid orals. Parenterals, and
semisolid preparations. Basic requirements for design of product, facility, equipment
selection.

6. Personnel, Pharmaceutical process validation for various products.

7. Quality Assurance: GMP considerations, quality assurance and process control. Total quality
management and productivity. ISO 9000 Salient features.

8. Optimization Techniques: Optimization parameters, classical optimiza-tion, statistical design

and applied optimization methods.

9. 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.

10. Machinery Engineering : Introduction to mechanical, electrical and electronic parts of

pharmaceutical machinery, equipments. Material handing for various pharmaceutical
products.

11. Safety : Industrial hazards due to fire, accident, mechanical and electrical equipment,
chemical and pharmaceuticals, monitoring and preventive system.

12. Effluent Testing and Treatment : Pharmaceutical industry.

13. 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

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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.

5. Applications of Statistical methods for assessment of reliability and reproducibility of

results: random selection of samples for testing.

6. Inprocess quality control for manufacturing reliability.

7. Development of drug information profiles.

8. Various pharmacopoeias of different countries and their gross knowledge.

9. 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. Smith, Chemical stability, MacGraw Hill publication, New Delhi.

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