INTRODUCTION:

1. Dispensing and General Pharmacy:

Definition:

Pharmacy is the science and technique of preparing and dispensing drugs. It is a health profession that links health sciences with chemicals sciences and aims to ensure the safe and effective use of pharmaceutical drugs.

Significance:

The subjects will provide basic knowledge of compounding and dispensing of pharmaceutical products. It states the part of a typical medication container label. It also help to apply basic mathematical calculation in the compounding and dispensing, and to calculate the dose according to need of patient by using various formulas

Objective:

The student shall be given orientations to know the origin of pharmacopoeias on procedure of medicines, pharmaceutical calculation and interpretations of incompatibilities.

Outcomes:

Student will be familiar with the Hospital pharmacy organization, drug distribution procedures dispensing, storage, incompatibilities and patient related factors. ^(1-2)

2. Pharmaceutical Inorganic Chemistry:

Definition:

Pharmaceutical chemistry is a branch of chemistry that deals with the chemicals, bio chemicals and pharmacological aspects of drugs. It includes synthesis/identification, structural modification, Study of the chemical characteristic, biochemical changes after drug administration and there

Significance:

Pharmaceutical inorganic chemistry which deals with study of both non-essential and essential elements about their preparation, standards of purity, test for identification, storage, different formulations and their storage conditions and therapeutic uses.

Objective:

The subject has been designed to make the students understands different categories of inorganic drugs\compounds which are used as medicinal agents.

Outcome:

On the completion the student will be familiar with categories of compounds or drugs which are used as medicines. ⁽³⁾

3. Pharmaceutical Organic Chemistry:

Definition:

Compounds used as medicines are most often organic compounds. This deals with the composition and preparation of chemical compounds used in medical diagnosis and therapies.

Significance:

Pharmaceutical science is a highly interdisciplinary field. It involves different areas of science, which are integrated to bring out pharmaceutical drug compounds.

Objective:

The organic compounds are classified based on their functional groups and character. The basic principles and mechanism of different types of organic reactions are explained in an elaborative manner.

Outcome:

The detail study on the mechanisms involved in various reactions would help the students to understand the synthesis of higher organic compounds. ⁽⁴⁾

4. Anatomy Physiology and Health Education:

Anatomy and physiology, which study the structure and function of organisms and their parts.

Significance:

A good understanding of anatomy and physiology is the basis of all medicines. Without knowing how the body works, how it is made up and how it can go wrong, we cannot even begin to design effective treatments and interventions, including surgery or new pharmaceutical drugs .Disease is deviation from the normal, and if we know the normal structure and function it is very easy to realize where the problem is coming from.

Objective:

This course is designed to impart a fundamental knowledge on the structure and the functions of the human body.

Outcome:

Describes the structure and functions of various organs of the human body and mechanisms in the maintenance of normal functioning and disease state are knows. ^(5-6)

5. Remedial Mathematics:

Definition:

This subject deals with introduction to algebra, trigonometry, differential calculus, integral calculus.

Significance:

Remedial education is signed to assist students in order to achieve expected competencies in core academic skills such as literacy and numeracy.

Objective:

This is an introductory course in mathematics, the subject deals with introduction to algebra, trigonometry, differential calculus, integral calculus etc.

Outcome:

The student will learn the basics of mathematics which will be helpful in pharmaceutical calculation in the higher classes. ^(7-8)

6. Remedial biology:

Definition:

It gives detail study on natural sources such as plant and animal origin. This subject deals with the plant cell, animal cell classification.

Significance:

This subject deals with the plant cell, animal cell classification plant kingdom and study of animal issues.

Objective:

This is an introductory course in biology which gives details study on natural sources such as plant and animal origin. This subjects deals with the plant cell , animal cell classification plant kingdom and study of animal issues and study about frogs and some animals.

Outcome:

The student will learn details about plant and animal cell plant taxonomy classification and some aspects of physiology of frog and animals. ^(9-10)

7. English:

Definition:

In view of the going importance of English as a tool for global communication and the consequent on trainings students to acquire communicative competence, the syllabus has been designed to develop linguistic and communicative competence of engineering students.

Significance:

In the English classes, the focus should be on the skills of reading, writing, listening and speaking and for this the teachers should use the text prescribed for study. The text for non-detailed study is for extensive reading/reading for pleasure. Hence, it is suggested that they read it on their on a topic selected for discussion in a class.

Objective:

This subject includes the language proficiency of the student in English with emphasis on LSRW skills. This subject also develops the study skills and communication in formal and informal situations.

Outcome:

The student shall gain confidence using language in verbal situations. ^(11-12)

Subjects designed for B Pharmacy second year (1^st semester):

8. Pharmaceutical Unit Operation I:

Definition:

Unit operation is a basic step in a process. Unit operation involves a physical change or chemical transformation such as operation, crystallization evaporation, filtration, polymerization, and other reactions. For example in milk processing, homogenization, pasteurization, chilling and packaging are each unit operations which are connected to create the overall process.

Significance:

The subject will provide the knowledge of the design and operation of pharmaceutical units and of the steps of development of dosage forms through to the final product and submission to the health authorities for production license and marketing.

Objective:

The student shall be exposed to various aspects of handling of fluids, application of filtration, centrifugation, crystallization and humidification in pharmaceutical industry.

Outcome:

Student will understand the concepts of fluid flow, parameter of filtration, centrifugation, crystallization and humidification. ^(13-15)

9. Pharmaceutical Organic Chemistry II:

Objective:

The chemistry of highly complicated organic compounds like polynuclear hydrocarbons and heterocyclic compounds are discussed along with their stereo chemical aspects.

Outcome:

As the structural and stereo chemical aspects and chemistry of organic compounds are discussed, it would help the students to have a good command over structural composition of organic compounds to evaluate and analyze the chemistry of these compounds. ^(16-17)

10. Anatomy, Physiology and Pathophysiology:

Objective:

This course is designed to impart a fundamental knowledge on the structure and functions of the human body. Since a medicament, which is produced by pharmacist, is used to correct the deviations in human body, it enhances the understanding of how the drugs act on the various body systems in correcting the diseases state of the organs.

Outcome:

Knowledge on structure and functioning of various organs of the human body and the interlinked mechanisms in the maintenance of normal functioning (homeostasis) of human body and the pathological states. ^(18-19)

11. Physical Pharmacy I:

Definition:

Physical pharmacy is associated with an area of pharmacy that deals with the contitative theoretic principle of science as they apply to the practice of pharmacy.

Significance:

Physical pharmacy integrates knowledge of mathematics, physics and chemistry and applies them to the pharmaceutical dosage form development .Physical pharmacy provides the bases for understanding the chemical and physical phenomena that govern the in vivo and in vitro actions of pharmaceutical products. It enables the pharmacist to make rational decisions on scientific bases concerning the art and technology of solution, suspensions, emulsions etc.

Objective:

The students shall know important physical properties of drug molecules, phase value and its importance and different law of thermodynamics, electrolyte and non-electrolyte solutions.

Outcome:

Student will know about physical properties of molecules, three laws of thermodynamics and they also understand the importance of these studies in the physical pharmaceutics and formulation development. ^(20-21)

12. Statistical Methods and Computer Application:

Definition:

Statistics is the mathematical science involving the collection, analysis and interpretation of data.

Significance:

The subject will provide a thorough knowledge of statistical techniques and application of computer in Pharmacy.

Objective:

The objective of the course, centered on various techniques, collection of data and its treatment; probability and distribution, correlation, regression and statistical inferences, besides computer applications.

Outcome:

At the end of the course expected outcomes are thorough knowledge of statistical techniques and application of computer in pharmacy. ^(22-23)

Subjects designed for Second Year (second semester):

13. Pharmaceutical Biochemistry:

Definition:

Biochemistry, deals with the chemical compounds and processes occurring in organism. It is also define as the science concern with the chemical basis of life.

Significance:

Biochemistry is actually a dynamic, exciting science that contributes important information to biology, medicines, nutrition, agriculture, physiology, genetics and immunology.

Objective:

The metabolism of complex biochemical compounds would make the student to gain a good knowledge about biochemical organization in the human system.

Outcome:

The metabolism of complex biochemical compounds would make the students to gain a good knowledge about biochemical organization in the human system. ^(24-26)

14. Pharmacognosy:

Definition:

A branch of pharmacology dealing with medicinal substances of biological origin and especially medicinal substance obtain from plants. It is a science of biogenic or nature derived pharmaceuticals and poisons.

Significance:

The medicine are traditionally be used by our rishi-muni and Pharmacognosy deals with this traditional knowledge, so ignition of pharmacy field is due to pharmacognosy. The pharmacognosy has played an important role in the development of various departments of the science. Pharmacognosy gives a sound knowledge of the vegetables drugs under botany and animal drugs under zoology.

Objective:

The course provides a brief introduction to plant systematic. Significant poisonous and medicinal plants, together with natural medicines, will be discussed.

Outcomes:

After completion of course the student will be able to understand the different types of natural products, their occurrence, structure, biosynthesis and properties. ^(27-28)

15. Environmental Studies:

Definition:

Environmental studies are the scientific study of the environmental system and the status of its inherent or induced changes on organisms. It includes not only the study of physical and biological characters of the environment but also the social and culture factors and the impact of man environment.

Significance:

This subject will impart basic knowledge about the environment and its allied problem. Environmental education should be compulsory, right from the primary up to the post graduate stage.

Outcome:

After the completion of subject the student will be understand the interrelationship between organisms in population and communities. ^(29-30)

16. Pharmaceutical Unit Operation II:

Objective:

The student shall be taught on operations like evaporation, drying, objective of size reduction, size separation and mixing.

Outcome:

Student will be familiar with concepts of evaporation, drying, size reduction, mixing and understand the pharmaceutical applications in industry. ^(31-33)

17. Physical Pharmacy: II

Objective:

The student shall be taught on industrial phenomenon of liquids, rate and order of reactants, micrometrics, flow of liquids and type of colloids.

Outcome:

Student will know about influence of temperature and other factors on rate of reactants, interfacial phenomenon, particle size and distribution, Newtonian and Non-Newtonian flows. ⁽³⁴⁾

Subjects designed for B Pharmacy Third Year (first semester):

18. Pharmaceutical Analysis:

Definition:

The pharmaceutical analysis is a branch of chemistry, which involves the series of process for the identification, determination, quantization and purification of any unknown compound or substance.

Significance:

Pharmaceutical analysis plays an important role in both the development process and GMP manufacturing, It concerns about drug safety, costly development programs, complex manufacturing. Pharmaceutical analysis services are focused on supporting product development, GMP manufacturing and distribution, from an early phase of development through to manufacturing and post-marketing analytical support.

Objective:

The basic concepts and analytical techniques of various pharmaceuticals are discussed in a detailed manner.

Outcomes:

Student will understand the basic concepts and analytical techniques of various pharmaceuticals in a detailed manner. ^(35-36)

19. Pharmaceutical Microbiology:

Definition:

It deals with the study of microorganisms which are responsible for the production of antibiotics, enzymes, vaccines, vitamins and other pharmaceutical substances. It is also the study of microorganisms which can contaminate pharmaceutical products, raw materials, manufacturing areas and foods.

Significance:

The most important contribution of microbiology to the pharmaceutical industry is the development of antibiotics. All antibiotics were originally the products of microbial metabolism. Vaccines are also a very important contribution of microbiology towards development of drugs.

Objective:

Microbiology is always considered to be an essential component of pharmacy curriculum because of its relevance to pharmaceutical sciences and more specifically to pharmaceutical industry.

Outcome:

Upon completion of the subject student shall be able to know the anatomy, identification and cultivation of microorganisms, and perform sterilization of various pharmaceutical products, equipment culture media etc. ^(37-38)

20. Pharmacognosy II:

Objective:

To have knowledge of the formation of pharmaceutically important secondary metabolites in plants and their commercial significance. The role of fibers, natural sweeting agents, colorants, volatile oils, tannins, resins in pharmaceutical, cosmetic and food industry. To make the student aware of what is Ayurveda and its various preparation.

Outcome:

After the study of course, the student shall be able to know about the phytopharmaceuticals of commercial significance and the various applications of the crude drugs in the preparation of formulation as medicaments and excipients (flavors, perfumes, sweeteners and colorants). ^(39-40)

21. Pharmaceutical Technology I:

Definition:

The application of scientific knowledge or technology to pharmacy, pharmacology and the pharmaceutical industry. It includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging and storing of drugs and other preparations used in diagnostic and determinative procedures and in the treatment of patients.

Significance:

Pharmaceutical technology is a collective term for technologies to develop candidate compounds that have either been discovered or created into commercial pharmaceutical products. These products are made by transforming chemical compounds with useful effects on the human body into high quality dosage forms that can appropriately exhibits effects against disease.

Objective:

The student shall be taught on preformulation factors and objectives of preformulation, stability and bioavailability of formulation, concept of products, semisolids, aerosols and cosmetic preparations.

Outcome:

The students shall be exposed to various aspects of pharmaceutical product preparations and evaluations of tablets, capsules etc. ^(41-42)

22. Pharmacology I:

Definition:

Pharmacology is the science of drug action on biological systems. In this entirety, it embraces knowledge of the sources, chemical properties, biological effects and therapeutic uses of drugs.

Significance:

It is a science that is basic not only to medicine, but also to pharmacy, nursing, dentistry and veterinary medicine. Pharmaceutical studies range from those that determine the effects of chemical agents upon sub cellular mechanisms, to those that deal with the potential hazards of pesticides and herbicides, to those that focus on the treatment and prevention of major diseases by drug therapy.

Objective:

The subject will provide an opportunity for the student to learn about the drug with regard to classification Pharmacodynamics and pharmacokinetics aspects, adverse effects, uses, dose, and route of administration, precautions, and interaction with other drugs.

Outcome:

Student shall be understand the pharmacological aspects of drugs, importance of pharmacology subject as a basis of therapeutics and correlate the knowledge therapeutically. ^(43-44)

Subjects of Third Year (second semester):

23. Medicinal Chemistry:

Definition:

Medicinal chemistry is the chemistry discipline concerned with the design, development and synthesis of pharmaceutical drugs. The discipline combines expertise from chemistry and pharmacology to identify, develop and synthesize chemical agents that have a therapeutic use and to evaluate the properties of existing drugs.

Significance:

Medicinal chemistry is a specialized science that has evolved to encompass a broad range of disciplines concerned with the identification, synthesis of compounds for therapeutic use. Medicinal chemistry is now increasingly involved in drug discovery and development process.

Objective:

The basic consideration of drug metabolism and medicinal substances belonging to different categories are discussed in an elaborative manner. The synthesis and mechanism of action of the medicinal compounds are explained in an organized way which helps the students to understand the medicinal uses of the compounds.

Outcome:

The students gain good knowledge about the usage of medicinal substances, the synthesis and drug-drug interactions, so that they can get involved with confidence in the patient counseling. ^(45-46)

24. Pharmaceutical Technology II:

Objective:

Student will know the formulation and evaluation of tablets, coated tablets, capsules, micro-encapsules and parenteral preparations in laboratories and industrial scale.

Outcome:

The students shall be exposed to various aspects of pharmaceutical product preparations and evaluations of tablets, capsules etc. ^(47-48)

25. Pharmacology II:

Objective:

This subject will provide an opportunity for the student to learn about the drug with regard to classification, Pharmacodynamics and pharmacokinetic aspects, adverse effects, uses, dose, route of administration, precautions, contraindications and interaction with other drugs.

Outcome:

Understands the pharmacological aspects of drugs, importance of pharmacology subject as a basis of therapeutics and correlate the knowledge therapeutically. ^(49-51)

26. Chemistry of Natural Products:

Definition:

Natural Products Chemistry deals with chemical compounds found in nature that usually has a pharmacological or biological activity for use in pharmaceutical drug discovery and drug design.

Significance:

The chemistry of natural products is a hybrid science combining in itself the theory of organic chemistry with experimentation. The term natural products is used to describe secondary metabolites which are organic compounds of natural origin having molecular weights less than 1500 amu. The term thus excludes naturally occurring macromolecules such as proteins, nucleic acids and polysaccharides which are dealt with under biochemistry.

Objective:

The chemistry including the structure elucidation of the natural products belonging to different groups such as amino acids, alkaloids, carbohydrates, steroids etc., are discussed in depth.

Outcome:

The knowledge of the students is enhanced with the clear information about the natural products which are having medicinal importance. ⁽⁵²⁾

27. Pharmaceutical Jurisprudence:

Definition:

The word jurisprudence is derived from the Latin term juris prudentia, which means “the study knowledge, or science of law”. Pharmaceutical jurisprudence is the study of rules and regulations of pharmacy, pharmacy practice and also relating to drugs and pharmaceutical.

Significance:

Pharmacist, pharmacies, drugs and pharmaceutical s are regulating in every country. Therefore, pharmacists specifically practicing pharmacist must be aware of the regulations that apply to their professional activities. It appears that the goal of the course is to make student a lawyer in pharmaceutical regulations.

Objective:

The objective of the course is to expose the students, all the laws and roles, which are vogues in the country. The scope of the course is extended to update the all the laws and roles including recent amendments.

Outcome:

The outcome which are expected from the students at the end of the course are; Familiarization of the students with all the legal tends and enforceable in the country, besides Pharmaceutical ethics and policies. ^(53-54)

28. Advanced Communication Skills:

Definition:

The introduction of the Advanced Communication skills lab is considered essential at 3^rd year level. At this stage, the students need to prepare themselves for careers which may require them to listen to, read, speak and write in English both for their professional and interpersonal communication in the globalized context.

Significance:

The proposed course should be a laboratory course to enable students to use ‘good’ English and to perform debates, group discussion, facing interviews, projects etc.

Objective:

To improve the students ‘fluency in English’ through a well-developed vocabulary and enable them to listen to English spoken at normal conversational speed by educated English speakers and respond appropriately in different socio-cultural and professional contexts.

Outcome:

Students shall know the sound of vocabulary and its proper use contextually. ⁽⁵⁵⁾

Subjects designed for Fourth Year (I Semester):

29. Pharmacognosy III:

Objective:

To learn about the therapeutically important crude drugs and phytopharmaceuticals under a suitable pharmacognostic scheme and the important of plant tissue culture in pharmacy. To make the student aware of biologically important molecules from marine sources and neutraceuticals

Outcome:

Since it is being the last part of Pharmacognosy subject, the student must be enriched with the knowledge on the crude drugs in a systematic way and in the use of crude drugs and phytopharmaceuticals in various systems of medicine for the treatment of different ailments and in various industries. ^(56-57)

30. Biopharmaceutics and Pharmacokinetics:

Definition:

It is the study of the factors influencing the bioavailability of a drug in man and animals and the use of this information to optimize pharmacological or therapeutic activity of drug products in clinical application. Pharmacokinetics, is a branch of pharmacology dedicated to determining the fate of substances administered to a living organism.

Significance:

Biopharmaceutics is the study of the relationship of the physico-chemical properties and in vitro behavior of the drug and drug product on the delivery of the drug to the body under normal or pathologic conditions. Pharmacokinetics describes how the body affects a specific xenobiotic/chemical after administration through the mechanisms of absorption and distribution, as well as the metabolic changes of the substance in the body.

Objective:

This course is designed to impart fundamental knowledge of Biopharmaceutics and Pharmacokinetics. It also helps to know how the absorption distribution, metabolism, excretion takes place and bioavailability and bioequivalence parameters.

Outcome:

The students shall be able to understand Bioavailability, Bioequivalence, Biopharmaceutical parameters, Pharmacodynamics and pharmacokinetics of the drug. It also explains the ADME (Abbreviation in pharmacokinetics and pharmacology for Absorption Distribution Metabolism and Excretion.) of the drug besides non-linear pharmacokinetics. ^(58-59)

31. Pharmacology III:

Objective:

This subject will provide an opportunity for the student to learn about the drug with regard to classification, Pharmacodynamics and pharmacokinetics aspects, adverse effects, uses, dose, route of administration, precautions, contra indicators and interaction with other drugs. The basic practical knowledge relevant to therapeutics will be imparted. This course is designed to impart knowledge and skills necessary for contribution to quality use of medicines. Chapters dealt cover briefly pathophysiology and mostly therapeutics of various diseases. This will enable the student to understand the pathophysiology of common diseases and their management.

Outcome:

Understand the pharmacological aspects of drugs, importance of pharmacology subject as a basis of therapeutics and correlate the knowledge therapeutically. Knowledge on experimental methodologies on various animal models is carried out. The pathophysiology of selected disease states and the rationale for drug therapy and the therapeutic approach to management of these diseases. ^(60-62)

32. Medicinal Chemistry –II:

Objective:

The drug discovery and design with respect to the lead molecules and its optimization is clearly discussed. The concept of CADD is also discussed. Sufficient information about various antibiotics and their chemotherapeutic agents are also studied in depth.

Outcome:

The students would be in a position to participate in the community pharmacy activities with the knowledge they gained through the study of the various topics of the syllabus. ^(63-64)

33. Pharmacy Administration:

Definition:

Pharmacy Administration is an applied field which adopts and adapts principles and theories from different areas of psychology, medical sociology, marketing, and economics to address the health care problems at both the individual patient and population level.

Significance:

Pharmacists dispense drugs to patients and work with physicians to develop drug therapies. Many pharmacists also research and develop new medications. Pharmaceutical administration may have similar responsibilities.

Objective:

This course will provide the knowledge of the various areas as features of business Organizations, manufacturing management, social pharmacy etc.

Outcome:

At the end of the course, these students will be familiarized with above all areas. ^(65-66)

34. Seminar/Industrial visit:

A seminar is a form of academic instruction, either at an academic institution or offered by a commercial or professional organization. Industrial visit is very important to any student undergoing professional education such as Engineering, Business management, Pharmacy etc. It helps the students to gain first-hand information regarding functioning of the industry.

Subjects designed for Fourth Year (second semester):

35. Pharmaceutical Biotechnology:

Definition:

Pharmaceutical Biotechnology is the science that covers all technologies required for the production, manufacturing and registration of biological drugs. Biotechnology refers to the application of biological systems, living organisms, or their derivatives in making or modifying products or processes for specific use.

Significance:

Biotechnology is used in various fields including agriculture, food science, and pharmaceuticals. Pharmaceutical companies use biotechnology for manufacturing drugs, pharmacogenomics, gene therapy, and genetic testing.

Objective:

Pharmaceutical biotechnology is considered to be a logical extension of pharmaceutical microbiology, thus expected to show a dramatic change in the drug product scenario in future. This course is designed to impart knowledge on isolation of industrially interesting microbes, various techniques employed in biotechnology viz, r-DNA technology, Hybridoma technology, enzyme technology and the products derived using these techniques.

Outcome:

Upon completion of the course, the student shall be able to know screening of industrially interesting microbes, optimize fermentation process parameters. ^(67-69)

36. Pharmaceutical Analysis-II:

Objective:

The principals involved in the determination of various bulk drugs and formulations are discussed. Modern methods and instrumental techniques are applied in the study and analysis of pharmaceutical substances.

Outcome:

The students are exposed to the modern instrumental techniques for the study of pharmaceuticals to a high level which would be useful for their future in academia and industry. ^(70-71)

37. Human Values and Professional Ethics:

Definition:

Principal human values are the foundation in which professional ethics are build. Professional ethics encompass the personal, organizational, and corporate standards of behavior expected of professional.

Significance:

The subject enables us to understand “what is valuable” for human happiness is called value education. Values form the basis for all our thoughts, behaviors and actions.

Objective:

It facilitates the development of a Holistic perspective among students towards life, profession and happiness, based on a correct understanding of the Human reality and rest of the Existence.

Outcome:

The students are able to sincerely evaluate the course and share with their friends. They are also able to suggest measures to make the course more effective and revalent. ^(72-73)

38. Clinical Pharmacy Practice:

Definition:

Clinical Pharmacy is the branch of pharmacy in which pharmacists provide patient care that optimizes the use of medication and promotes health, wellness, and disease prevention.

Significance:

Clinical pharmacists interact directly with patients in several different ways. They use their knowledge of medication to determine if a medication plan is appropriate for their patient.

Objective:

To impart quality use of medicines and their therapeutics of various diseases management Monitor adverse drug reaction interpret selected laboratory results of specific diseases states, retrieve, analyze, interpret and formulate drug or medicine information.

Outcome:

Know the Pathophysiology of selected diseases states and the rationale for drug therapy, their therapeutic approach in management of diseases. Understand the needs to identify the patient-specific parameters relevant in initiating drug therapy and its monitoring. ^(74-75)

39. Novel Drug Delivery System and Regulatory Affairs:

Definition:

Regulatory affairs (RA) also called government affairs is a profession within regulated industries, such as pharmaceuticals, medical devices etc. Regulatory affairs also have a very specific meaning within the health care industries.

Significance:

Regulation involves extensive evaluation of a particular drug product to ensure production of public health, promotion of the product, Drug registration, marketing authorization, import and distribution, pharmacovigilance. The regulatory affairs professional is the only one who is completely responsible for holding products in compliance and maintaining all the records.

Objective:

This course is design to impart knowledge on control drug delivery system including oral transdermal Mucoaddhesive, targeted (liposomes and Nano particles) it also help to know how regulatory agencies [Indian CDSCO (Central Drugs Standard Control Organization) USFDA (United States Food and Drug Administration) Canadian HPFBI( Health Products and Food Branch Inspectorate) Australian TGA(Therapeutic Goods Administration) act on release of NDA(New Drug Application) and ANDA(Abbreviated New Drug Application).

Outcome:

Students shall able to know the control, sustain drug delivery system, their method of preparation. They also know how regulatory agencies help filling and submissions of USFDA. Student shall be able to know the validation analytical methods. ^(76-77)

40. Project work and Comprehensive viva:

There will be a project work in the final year for students. Before the end B. Pharm sixth semester, for each student, a project supervisor shall be appointed by the Director, Pharmacy Wing. The student shall choose a project topic in consultation with the supervisor. A synopsis on the project topic should be prepared in the prescribed format and submitted to the Director, Pharmacy Wing for approval. Few topics or ideas are mentioned as follows.

1. Herbal Drug

2. Pharm informatics

3. Computer aided drug design

4. Neutraceuticals

5. Nano Technology

6. Bio Technology

7. Pharmaco economics.

Objective:

This course develops an understanding of the nature and importance of research, provide a foundation for future research activity and enhance the student’s ability to work as members of a team and to present research findings.

Outcome:

At the end of the course students will be able to conduct effective literature searches, critically evaluate literature and published research, identify appropriate research methodologies etc.

CONCLUSION:

After the completion of the program student is eligible for the award of B .Pharmacy and gain thorough knowledge of all the concepts of subjects as mentioned above.

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Received on 08.12.2016 Accepted on 22.01.2017

Asian J. Res. Pharm. Sci. 2017; 7(1): 38-48.

DOI: 10.5958/2231-5659.2017.00007.8

ABSTRACT: