Course Outcomes - M Pharm

Sl.

No.

Name of the

Program

Name of the Course

Course Outcome

1

M. Pharm.

Drug Delivery Systems

·          Drug delivery system give a detailed            information transporting                                    a

pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect.

·          Also it refers to approaches, formulations,                   technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely                   achieve                        its desired therapeutic                   effect with suitable drug delivery.

·          Vaccine delivery and different mode of application approach for clinical use.

·          They know the different types of Drug carrier used in the process of drug delivery which serves to improve the selectivity, effectiveness, and/or                    safety

of drug administration.

·          The students will know the latest drug delivery knowledge and think to develop new formulation based on the individual Requirement.

·          Recent                            developments in protein                  and                  peptide for parenteral delivery approaches   will                  give                  new dimension of drug deliver for

antibiotics, insulin, etc.

2

Modern Pharmaceutics

·          Basics of medical devices

and IVDs, process of development, ethical and

quality considerations harmonization initiatives for approval and marketing of medical devices and IVDs regulatory approval process for medical devices and IVDs in India, US, Canada, EU, Japan and ASEAN clinical evaluation and investigation

of medical devices and IVDs

3

Regulatory Affairs

·          The Concepts of innovator and generic drugs, drug development process

·          The Regulatory guidance’s and guidelines for filing and approval process

·          Preparation of Dossiers and their submission to regulatory agencies in different countries

·          Post approval regulatory requirements for actives and drug products

·          Submission of global documents in CTD/ eCTD formats

·          Clinical trials requirements for approvals for conducting clinical trials

·          Pharmacovigilence              and process              of    monitoring               in

clinical trials

4

Molecular Pharmaceutics             (Nano Tech            and            targeted DDS)

·          The various approaches for development of novel drug delivery systems.

·          The criteria for selection of drugs and polymers for the development of NTDS

·          The       formulation       and

evaluation of novel drug delivery systems.

5

Advanced Biopharmaceutics                             and pharmacokinetics

·          The basic concepts in biopharmaceutics and pharmacokinetics.

·          The use raw data and derive

the pharmacokinetic models

and parameters the best describe the process of drug absorption, distribution, metabolism and elimination.

·          The critical evaluation of biopharmaceutic studies involving drug product equivalency.

·          The design and evaluation of dosage regimens of the drugs using pharmacokinetic and biopharmaceutic parameters.

·          The potential clinical pharmacokinetic problems and application of basics of

pharmacokinetic

6

Computer Aided drug delivery System

·          History of Computers in Pharmaceutical Research and Development

·          Computational Modeling of Drug Disposition

·          Computers in Preclinical Development

·          Optimization Techniques in Pharmaceutical Formulation

·          Computers in Market Analysis

·          Computers in Clinical Development

·          Artificial Intelligence (AI) and Robotics

·          Computational                               fluid

dynamics(CFD)

7

Cosmetics                            and Cosmeceuticals

·          Key    ingredients         used                      in cosmetics            and

cosmeceuticals.

·          Key building blocks for various formulations.

·          Various key ingredients and basic science to develop cosmetics and

·          cosmeceuticals

·          Scientific knowledge to develop cosmetics and with desired Safety, stability, and

efficacy.

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No.

Name of the

Program

Name of the Course

Course Outcome

1

M. Pharm.

Good Regulatory Practices

·          The key elements of current Good Manufacturing Practices, Good Laboratory Practices, Good Automated Laboratory Practices, Good Documentation Practices and Good Regulatory Practices.

·          The check lists for various Good Pharmaceutical Practices and Prepare SOPs for Good Pharmaceutical Practices

·          Implement Good Pharmaceutical Practices in the Industries and Prepare for the Audit of the Pharmaceutical Industries.

2

Documentation and Regulatory Writing

·          Know the various documents pertaining to drugs in pharmaceutical

·          industry

·          Understand the basics of regulatory compilation

·          Create and assemble the regulation submission as per the

·          requirements of agencies

·          Follow up the submissions and post approval document requirements

3

Clinical Research Regulation

·          History, origin and ethics of clinical and biomedical research and evaluation

·          Clinical drug, medical device development process and different types and phases of clinical trials

·          Regulatory requirements and guidance for conduct of

clinical trials and research

4

Regulations And Legislation For Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, And Food & Nutraceuticals In India And Intellectual Property

Rights

·          Know different Acts and guidelines that regulate Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals industry in India.

·          Understand the approval process and regulatory requirements for

·          Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food& Nutraceuticals

5

Regulatory Aspects of Drugs and Cosmetics

·          Process of drug discovery and development and generic product development

·          regulatory approval process and registration procedures for API and drug products in US, EU

·          Cosmetics regulations in regulated and semi-regulated countries

·          A comparative study of India with other global regulated

markets

6

Regulatory Aspects of Herbal

& Biologicals

·          Know the regulatory Requirements for Biologics and Vaccines

·          Understand the regulation for newly developed biologics and biosimilars

·          Know the pre-clinical and clinical development considerations of biologics

·          Understand the Regulatory Requirements of Blood and/or Its Components Including Blood Products and label

requirements

7

Regulatory Aspects of Medical Devices

·          Basics of medical devices and IVDs, process of development, ethical and quality considerations harmonization initiatives for approval and marketing of medical devices and IVDs regulatory approval process for medical devices and IVDs in India, US, Canada, EU, Japan and ASEAN clinical evaluation and investigation

of medical devices and IVDs

8

Regulatory Aspects Of Food & Nutraceuticals

·          Know the regulatory Requirements for nutraceuticals

·          Understand the regulation for registration and labeling of nutraceuticals and food supplements in India, USA

and Europe.

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No.

Name of

the Program

Name of the Course

Course Outcome

1

M Pharm

Advanced Pharmacology-I

·          The students would appreciate the basic knowledge in the field of pharmacology pertaining to the drugs and its therapeutic applications

·          They would have elaborately learnt the recent advances in the drugs used for the treatment of various diseases.

·          They would have understood the concepts of drug action and mechanisms involved.

·          They would have discussed the pathophysiology and pharmacotherapy of certain diseases

·          They would have understood the underlying mechanism of drug actions at cellular and molecular level.

·          They would havelearnt the adverse effects, contraindications and clinical uses of drugs

used in treatment of diseases

2

Screening methods in Pharmacology

·          The students would appreciate the knowledge gained on preclinical evaluation of drugs and recent experimental techniques in the drug discovery and development.

·          They would have understood the maintenance of laboratory animals as per the guidelines, basic knowledge of various in-vitro and in-vivo preclinical evaluation processes

·          They would have appraised the regulations and ethical requirement for the usage of experimental animals.

·          They would have learnt to describe the various animals used in the drug discovery process and good laboratory practices in maintenance and handling of experimental animals

·          They would have learnt to describe the various screening methods involved in the drug discovery process

·          They   would   appreciate   to   correlate   the

preclinical data to humans

3

Cellular                       and Molecular

Pharmacology

·          The   students   would        have        understood          the fundamental knowledge on the structure and

functions of cellular components.

·          They would appreciate the interaction of these components with drugs. This would enable them to apply the knowledge in drug discovery process.

·          They would have learnt to explain the receptor signal transduction processes.

·          They would have learnt to explain the molecular pathways affected by drugs.

·          They would appreciate the applicability of molecular pharmacology and biomarkers in drug discovery process.

·          They   would   have   learnt   to   demonstrate

molecular biology techniques as applicable for pharmacology.

4

Advanced Pharmacology-II

·          The students would appreciate the basic knowledge in the field of pharmacology pertaining to the drugs and its therapeutic applications

·          They would have elaborately learnt the recent advances in the drugs used for the treatment of various diseases.

·          They would have understood the concepts of drug action and mechanisms involved.

·          They would have studied the pathophysiology and pharmacotherapy of certain diseases

·          They would have understood the underlying mechanism of drug actions at cellular and molecular level.

·          They would have learnt the adverse effects,

contraindications and clinical uses of drugs used in treatment of diseases

5

Principles                         of Toxicology

·          The students would appreciate the knowledge on the preclinical safety and toxicological evaluation of drug & new chemical entity.

·          They would have better understanding in the regulatory aspects for the toxicological evaluation of drugs and chemicals.

·          They would have studied the various types of toxicity studies and their procedure.

·          They would appreciate the importance of ethical and regulatory requirements for toxicity studies.

·          They would have studied the practical skills required to conduct the preclinical toxicity studies.

·          They would appreciate the use of experimental

animals for the different toxicological studies.

6

Principles of drug discovery

·          The students would appreciate the knowledge on the basics of drug

discovery.

·          They would have better understanding on the various stages of drug                                           discovery.

·          They would have studied the importance of the role of genomics, proteomics                                             and bioinformatics in drug discovery.

·          They would have studied on the various targets for drug discovery.

·          They would have better understanding on the lead seeking method and lead optimization

·          They would have learnt the importance of

the role of computer aided drug                                           design in drug discovery.

7

Clinical Pharmacology

·          The students would appreciate the knowledge on the clinical research.

·          They would get a better understanding in the regulatory requirements for conducting clinical trial.

·          They would have understand the types of clinical trial designs.

·          They would have studied the responsibilities of key players involved in clinical trials

·          They would have an understand on the safety monitoring, reporting and   close-out activities.

·          They would have studied the    principles of

Pharmacovigilance

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No.

Name of the

Program

Name of the

Course

Course Outcome

1

M. Pharm.

Modern Pharmaceutical Analytical Techniques

·          To understand the basic knowledge on assay of single and multiple component pharmaceuticals by using various analytical instruments

·          To develop basic practical skills using instrumentation techniques

·          Skills in selecting the suitable techniques for analysis of drugs and pharmaceuticals

·          To expand the theoretical knowledge on various instrumental techniques available for analysis of organic substances

·          To apply the knowledge learnt in developing new procedures of their own design

·          Comparing various methods of analysis and

their outcomes

2

Advanced Pharmaceutical Analysis

·          The student Will understand the concepts of Impurity profiling

·          The students will gain appropriate knowledge about appropriate analytical skills required for the analysis of impurities in the bulk drugs and various formulations.

·          The subject supply enough idea on the categorizing the impurities LIKE (INORGANIC, ORGANIC AND RESIDUAL SOLVENTS)

·          It supports to understand the official and non official methods to analyses the related

substance.

3

Pharmaceutical Validation

·          The Students learn on the importance of validation.

·          The student learns on the importance of patent and intellectual property rights.

·          The    students    are          trained       on          the qualification aspects of instruments.

·          The   importance    of         calibration     to   be performed for the instruments.

·          The various validation aspects to be carried out in the industry.

·          The   students   gain        knowledge     on how validation     are     carried        for           various

components.      Such                         as                         instrument

validation, cleaning validation and process

validation.

4

Food Analysis

·          Student shall be able to understand various analytical techniques in the determination of Food constituents

·          Student shall be able to understand various analytical techniques in the determination of Food additives,

·          Student shall be able to understand various analytical techniques in the determination of Finished food products

·          Student shall be able to understand various analytical techniques in the determination of Pesticides in food

·          Student shall be able to understand various analytical techniques in the determination of knowledge on food regulations

·          Student shall be able to understand various

analytical techniques in the determination of food legislations

5

Advanced Instrumentation Techniques

The student will know about

·          The detailed interpretation pattern for the organic substances

·          Theoretical aspects of the HPLC and GC techniques

·          Practical aspects and troubleshooting techniques for HPLC and GC techniques

·          Knowledge and skills in advanced instrumentation techniques for drug analysis

·          Theoretical aspects of hyphenated analytical techniques

·          Critical analysis of analytical problem and selection of appropriate analytical tool for the quantification of chemicals and

excepients

6

Modern                 Bio- analytical Techniques

·          The subject provides enough knowledge to conduct bioequivalence studies

·          It upgrade the method to conduct bioequivalence study for formulations by utilizing the proper regulatory guidelines

·          It improvers ideas and updating information on the current trend in GCP and GLP

·          Pupil will be exposed to both theoretical

and practical knowledge on quantification

of analyte present in the biological fluids

·          The subject content presents better understanding on different analyte enrichment technique as well the instrumentation technique.

7

Quality control and Quality Assurance

·          Student shall be able to understand the cGMP aspects in a pharmaceutical industry

·          Student shall be able to understand the importance of documentation

·          Student shall be able to understand the scope of quality certifications applicable to Pharmaceutical industries

·          Student shall be able to understand the responsibilities of QA department

·          Student shall be able to understand the responsibilities of QC department

·          Student shall be able to understand GLP and regulatory

Affairs

8

Herbal                  and cosmetic analysis

·          Student shall be able to understand the determination of herbal remedies

·          Student shall be able to understand various herbal regulations

·          Student shall be able to understand various analytical techniques in the determination of herbal products

·          Student shall be able to understand the herbal monographs

·          Student shall be able to understand various herbal drug interactions

·          Student shall be able to understand various

performance evaluation of cosmetic products

Sl.

No.

Name of the

Program

Name of the

Course

Course Outcome

1

M. Pharm.

Quality Management System

·          The student will understand the quality parameters and quality attribute in Pharmaceutical industry sectors

·          By studying and practicing the guidelines iso, nabl and other regulatory agencies student will predicts the current need of changes.

·          It provide the idea in the customers expectations in the quality pharmaceutical product.

·          student will know the importance of the quality of medicines in the public.

·          The subject will afford methodology in the regulatory body requirements for the

import and export pharmaceutical products.

2

Quality control and Quality Assurance

·          Student shall be able to understand the cGMP aspects in a pharmaceutical industry

·          Student shall be able to understand the importance of documentation

·          Student shall be able to understand the scope of quality certifications applicable to Pharmaceutical industries

·          Student shall be able to understand the responsibilities of QA department

·          Student shall be able to understand the responsibilities of QC department

·          Student shall be able to understand GLP and regulatory

Affairs

3

Product development and Technology Transfer

·          To apply the knowledge to develop new procedures of their own design of Pilot layouts

·          Student shall be able to understand the Quality by design practices of sterile and non sterile dosage forms

·          Student shall be able to understand the practices of packaging technology

·          Student shall be understand the Regulatory

requirements in drug development stages

·          Students shall understand the phase of technology transfer

4

Hazards                and Safety Management

·          To understand the energy resources in the to make eco-friendly industry environment

·          The course knowledge useful to Find hazards in work atmosphere

·          It creates the passage to understand, Determine and to take control measures to eliminate or minimize the level of the risks

·          It support the student to recognize the control measures to eliminate or minimize the level of the risks

·          It provides platform for formal process for hazard identification, risk assessment and control to effectively manage workplace and safety hazards

·            It develop proper understanding in the

stages of risk assesment

5

Pharmaceutical Validation

·          The Students learn on the importance of validation.

·          The student learns on the importance of patent and intellectual property rights.

·          The students are trained on the qualification aspects of instruments.

·          The importance of calibration to be performed for the instruments.

·          The various validation aspects to be carried out in the industry.

·          The students gain knowledge on how validation are carried for various components. Such as instrument validation, cleaning validation and process validation.

6

Audit                 and Regulatory Compliance

·          The student gain knowledge on the importance of auditing in pharmaceutical preparation.

·          The various forms of auditing are and how an audit process happens are briefed to the students.

·          Preparation of various audit checklist for the auditing.

·          when and what are the areas the auditing to be carried is taught to the student.

·          The Reporting form of the auditing process

is taught to the student.

·          The student practices the auditing process and reporting process.

7

Pharmaceutical Manufacturing Technology

·          Student shall be able to understand the common practice in the pharmaceutical industry developments

·          Student shall be able to understand the practices of aseptic process technology

·          Student shall be able to understand the practices of non sterile

·          manufacturing technology

·          Student shall be able to understand the practices of packaging technology

·          Student shall be able to understand understanding of principles and implementation of Quality by design (QbD)

·          Student shall be able to understand understanding of principles and implementation of process analytical technology (PAT) in pharmaceutical

manufacturing