rgpv syllabus MPharm PCI Grading System 2nd Semester Microsoft Word

<<<<<<< HEAD rgpv syllabus MPharm PCI Grading System 2nd Semester Microsoft Word - M Pharm PCI Syllabus all branches

ADVANCED PHARMACOLOGY - II (MPL 201T)

Scope

The subject is designed to strengthen the basic knowledge in the field of pharmacology and to impart recent advances in the drugs used for the treatment of various diseases. In addition, the subject helps the student to understand the concepts of drug action and mechanism involved

Objectives

Upon completion of the course the student shall be able to:

 Explain the mechanism of drug actions at cellular and molecular level

 Discuss the Pathophysiology and pharmacotherapy of certain diseases

 Understand the adverse effects, contraindications and clinical uses of drugs used in treatment of diseases

THEORY 60 Hrs

1. Endocrine Pharmacology

Molecular and cellular mechanism of action of hormones such as growth hormone,

prolactin, thyroid, insulin and sex hormones

Anti-thyroid drugs, Oral hypoglycemic agents, Oral contraceptives, Corticosteroids.

Drugs affecting calcium regulation

Chemotherapy
Cellular and molecular mechanism of actions and resistance of antimicrobial agents
such as ß-lactams, aminoglycosides, quinolones, Macrolide antibiotics. Antifungal, antiviral, and anti-TB drugs.
Chemotherapy
Drugs used in Protozoal Infections
Drugs used in the treatment of Helminthiasis Chemotherapy of cancer Immunopharmacology
Cellular and biochemical mediators of inflammation and immune response. Allergic or
hypersensitivity reactions. Pharmacotherapy of asthma and
COPD.
Immunosuppressants and Immunostimulants
12
Hrs

12
Hrs

12
Hrs
GIT Pharmacology
Antiulcer drugs, Prokinetics, antiemetics, anti-diarrheals and drugs for constipation
and irritable bowel syndrome.
Chronopharmacology
Biological and circadian rhythms, applications of chronotherapy in various diseases like
cardiovascular disease, diabetes, asthma and peptic ulcer
Free radicals Pharmacology
Generation of free radicals, role of free radicals in etiopathology of various diseases
such as diabetes, neurodegenerative diseases and cancer. Protective activity of certain important antioxidant
Recent Advances in Treatment:
Alzheimer’s disease, Parkinson’s disease, Cancer, Diabetes mellitus
12
Hrs

12
Hrs

REFERENCES
1. The Pharmacological basis of therapeutics- Goodman and Gill man‘s
2. Principles of Pharmacology. The Pathophysiologic basis of drug therapy by David E Golan et al.
3. Basic and Clinical Pharmacology by B.G -Katzung
4. Pharmacology by H.P. Rang and M.M. Dale.
5. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.
6. Text book of Therapeutics, drug and disease management by E T. Herfindal and Gourley.
7. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu.
8. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists
9. Robbins & Cortan Pathologic Basis of Disease, 9th Ed. (Robbins Pathology)
10. A Complete Textbook of Medical Pharmacology by Dr. S.K Srivastava published by APC Avichal Publishing Company.
11. KD.Tripathi. Essentials of Medical Pharmacology
12. Principles of Pharmacology. The Pathophysiologic basis of drug Therapy by David E Golan, Armen H, Tashjian Jr, Ehrin J,Armstrong, April W, Armstrong, Wolters, Kluwer-Lippincott Williams & Wilkins Publishers

PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II

(MPL 202T)

Scope:

This subject imparts knowledge on the preclinical safety and toxicological evaluation of drug & new chemical entity. This knowledge will make the student competent in regulatory toxicological evaluation.

Objectives:

Upon completion of the course, the student shall be able to,

 Explain the various types of toxicity studies.

 Appreciate the importance of ethical and regulatory requirements for toxicity studies.

 Demonstrate the practical skills required to conduct the preclinical toxicity studies.

THEORY 60 Hrs

1. Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive)

Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y

OECD principles of Good laboratory practice (GLP)

History, concept and its importance in drug development

Acute, sub-acute and chronic- oral, dermal and inhalational studies as per OECD guidelines.
Acute eye irritation, skin sensitization, dermal irritation & dermal toxicity studies.
Test item characterization- importance and methods in regulatory toxicology studies
Reproductive toxicology studies, Male reproductive toxicity studies, female reproductive studies (segment I and segment III), teratogenecity studies (segment II)
Genotoxicity studies (Ames Test, in vitro and in vivo Micronucleus
and Chromosomal aberrations studies)
In vivo carcinogenicity studies
IND enabling studies (IND studies)- Definition of IND, importance of IND, industry perspective, list of studies needed for IND submission.
12
Hrs

12
Hrs

12
Hrs

12
Hrs
Safety pharmacology studies- origin, concepts and importance of safety pharmacology.
Tier1- CVS, CNS and respiratory safety pharmacology, HERG assay. Tier2- GI, renal and other studies
Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies.
Alternative methods to animal toxicity testing.
12
Hrs

REFERENCES
1. Hand book on GLP, Quality practices for regulated non-clinical research and development (http://www.who.int/tdr/publications/documents/glp- handbook.pdf).
2. Schedule Y Guideline: drugs and cosmetics (second amendment) rules,
  2005, ministry of health and family welfare (department of health) New Delhi
3. Drugs from discovery to approval by Rick NG.
4. Animal Models in Toxicology, 3rd Edition, Lower and Bryan
5. OECD test guidelines.
6. Principles of toxicology by Karen E. Stine, Thomas M. Brown.
7. Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinform ation/guidances/ucm073246.pdf)

PRINCIPLES OF DRUG DISCOVERY (MPL 203T)

Scope:

The subject imparts basic knowledge of drug discovery process. This information will make the student competent in drug discovery process

Objectives:

Upon completion of the course, the student shall be able to,

 Explain the various stages of drug discovery.

 Appreciate the importance of the role of genomics, proteomics and bioinformatics in drug discovery

 Explain various targets for drug discovery.

 Explain various lead seeking method and lead optimization

 Appreciate the importance of the role of computer aided drug design in drug discovery

THEORY 60 Hrs

1. An overview of modern drug discovery process: Target identification, target validation, lead identification and lead Optimization. Economics of drug discovery.

Target Discovery and validation-Role of Genomics, Proteomics and Bioinformatics. Role of Nucleic acid microarrays, Protein microarrays, Antisense technologies, siRNAs, antisense oligonucleotides, Zinc ﬁnger proteins. Role of transgenic animals in target validation.

Lead Identification- combinatorial chemistry & high throughput screening, in silico lead discovery techniques, Assay development for hit identification.
Protein structure
Levels of protein structure, Domains, motifs, and folds in protein structure. Computational prediction of protein structure: Threading and homology modeling methods. Application of NMR and X-ray crystallography in protein structure prediction
Rational Drug Design
Traditional vs rational drug design, Methods followed in traditional drug design, High throughput screening, Concepts of Rational Drug Design, Rational Drug Design Methods: Structure and Pharmacophore based approaches
12
Hrs

12
Hrs

12
Hrs
Virtual Screening techniques: Drug likeness screening, Concept of pharmacophore mapping and pharmacophore based Screening,
Molecular docking: Rigid docking, flexible docking, manual docking; Docking based screening. De novo drug design. Quantitative analysis of Structure Activity Relationship
History and development of QSAR, SAR versus QSAR, Physicochemical parameters, Hansch analysis, Fee Wilson analysis and relationship between them.
QSAR Statistical methods – regression analysis, partial least square analysis (PLS) and other multivariate statistical methods. 3D-QSAR approaches like COMFA and COMSIA
Prodrug design-Basic concept, Prodrugs to improve patient acceptability, Drug solubility, Drug absorption and distribution, site specific drug delivery and sustained drug action. Rationale of prodrug design and practical consideration of prodrug design

12
Hrs

12
Hrs

REFERENCES
1. MouldySioud. Target Discovery and Validation Reviews and Protocols: Volume 2 Emerging Molecular Targetsand Treatment Options. 2007 Humana Press Inc.
2. Darryl León. Scott MarkelIn. Silico Technologies in Drug Target Identification and Validation. 2006 by Taylor and Francis Group, LLC.
3. Johanna K. DiStefano. Disease Gene Identification. Methods and Protocols. Springer New York Dordrecht Heidelberg London.
4. Hugo Kubiny. QSAR: Hansch Analysis and Related Approaches. Methods and Principles in Medicinal Chemistry. Publisher Wiley-VCH
5. Klaus Gubernator, Hans-Joachim Böhm. Structure-Based Ligand Design. Methods and Principles in Medicinal Chemistry. Publisher Wiley-VCH
6. Abby L . Parrill. M . Rami Reddy. Rational Drug Design. Novel Methodology and Practical Applications. ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
7. J. Rick Turner. New drug development design, methodology and, analysis. John Wiley & Sons, Inc., New Jersey.

CLINICAL RESEARCH AND PHARMACOVIGILANCE (MPL 204T)

Scope:

This subject will provide a value addition and current requirement for the students in clinical research and pharmacovigilance. It will teach the students on conceptualizing, designing, conducting, managing and reporting of clinical trials. This subject also focuses on global scenario of Pharmacovigilance in different methods that can be used to generate safety data. It will teach the students in developing drug safety data in Pre-clinical, Clinical phases of Drug development and post market surveillance.

Objectives:

Upon completion of the course, the student shall be able to,

 Explain the regulatory requirements for conducting clinical trial

 Demonstrate the types of clinical trial designs

 Explain the responsibilities of key players involved in clinical trials

 Execute safety monitoring, reporting and close-out activities

 Explain the principles of Pharmacovigilance

 Detect new adverse drug reactions and their assessment

 Perform the adverse drug reaction reporting systems and communication in Pharmacovigilance

THEORY 60 Hrs

1. Regulatory Perspectives of Clinical Trials:

Origin and Principles of International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines Ethical Committee: Institutional Review Board, Ethical

Hrs

	Guidelines for Biomedical Research and Human Participant-
	Schedule Y, ICMR
	Informed Consent Process: Structure and content of an
	Informed Consent Process Ethical principles governing informed
	consent process
2	Clinical Trials: Types and Design	12
	Experimental Study- RCT and Non RCT,	Hrs
	Observation Study: Cohort, Case Control, Cross sectional Clinical Trial Study Team
	Roles and responsibilities of Clinical Trial Personnel: Investigator,
	Study Coordinator, Sponsor, Contract Research Organization and
	its management

Clinical Trial Documentation- Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring- Safety Monitoring in CT
Adverse Drug Reactions: Definition and types. Detection and reporting methods. Severity and seriousness assessment.Predictability and preventability assessment, Management of adverse drug reactions; Terminologies of ADR.
Basic aspects, terminologies and establishment of pharmacovigilance
History and progress of pharmacovigilance, Significance of safety monitoring, Pharmacovigilance in India and international aspects, WHO international drug monitoring programme, WHO and Regulatory terminologies of ADR, evaluation of medication safety, Establishing pharmacovigilance centres in Hospitals, Industry and National programmes related to pharmacovigilance. Roles and responsibilities in Pharmacovigilance
Methods, ADR reporting and tools used in Pharmacovigilance
International classification of diseases, International Non- proprietary names for drugs, Passive and Active surveillance, Comparative observational studies, Targeted clinical investigations and Vaccine safety surveillance. Spontaneous reporting system and Reporting to regulatory authorities, Guidelines for ADRs reporting. Argus, Aris G Pharmacovigilance, VigiFlow, Statistical methods for evaluating medication safety data.
Pharmacoepidemiology, pharmacoeconomics, safety pharmacology
12
Hrs

12
Hrs

12
Hrs

12
Hrs

REFERENCES
1. Central Drugs Standard Control Organization- Good Clinical Practices, Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;2001.
2. International Conference on Harmonization of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice.E6; May 1996.
3. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.
4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons.
5. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications.
6. Handbook of clinical Research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone.
7. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.

PHARMACOLOGICAL PRACTICAL - II (MPL 205P)

To record the DRC of agonist using suitable isolated tissues preparation.
To study the effects of antagonist/potentiating agents on DRC of agonist using suitable isolated tissue preparation.
To determine to the strength of unknown sample by matching bioassay by using suitable tissue preparation.
To determine to the strength of unknown sample by interpolation bioassay by using suitable tissue preparation
To determine to the strength of unknown sample by bracketing bioassay by using suitable tissue preparation
To determine to the strength of unknown sample by multiple point bioassay by using suitable tissue preparation.
Estimation of PA2 values of various antagonists using suitable isolated tissue preparations.
To study the effects of various drugs on isolated heart preparations
Recording of rat BP, heart rate and ECG.
Recording of rat ECG
Drug absorption studies by averted rat ileum preparation.
Acute oral toxicity studies as per OECD guidelines.
Acute dermal toxicity studies as per OECD guidelines.
Repeated dose toxicity studies- Serum biochemical, haematological, urine analysis, functional observation tests and histological studies.
Drug mutagenicity study using mice bone-marrow chromosomal aberration test.
Protocol design for clinical trial.(3 Nos.)
Design of ADR monitoring protocol.
In-silico docking studies. (2 Nos.)
In-silico pharmacophore based screening.
In-silico QSAR studies.
ADR reporting

REFERENCES

Fundamentals of experimental Pharmacology-by M.N.Ghosh
Hand book of Experimental Pharmacology-S.K.Kulakarni
Text book of in-vitro practical Pharmacology by Ian Kitchen
Bioassay Techniques for Drug Development by Atta-ur-Rahman, Iqbal choudhary and William Thomsen
Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu.
Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists.

======= rgpv syllabus MPharm PCI Grading System 2nd Semester Microsoft Word - M Pharm PCI Syllabus all branches

ADVANCED PHARMACOLOGY - II (MPL 201T)

Scope

Objectives

Upon completion of the course the student shall be able to:

 Explain the mechanism of drug actions at cellular and molecular level

 Discuss the Pathophysiology and pharmacotherapy of certain diseases

 Understand the adverse effects, contraindications and clinical uses of drugs used in treatment of diseases

THEORY 60 Hrs

1. Endocrine Pharmacology

Molecular and cellular mechanism of action of hormones such as growth hormone,

prolactin, thyroid, insulin and sex hormones

Anti-thyroid drugs, Oral hypoglycemic agents, Oral contraceptives, Corticosteroids.

Drugs affecting calcium regulation

Chemotherapy
Cellular and molecular mechanism of actions and resistance of antimicrobial agents
such as ß-lactams, aminoglycosides, quinolones, Macrolide antibiotics. Antifungal, antiviral, and anti-TB drugs.
Chemotherapy
Drugs used in Protozoal Infections
Drugs used in the treatment of Helminthiasis Chemotherapy of cancer Immunopharmacology
Cellular and biochemical mediators of inflammation and immune response. Allergic or
hypersensitivity reactions. Pharmacotherapy of asthma and
COPD.
Immunosuppressants and Immunostimulants
12
Hrs

12
Hrs

12
Hrs
GIT Pharmacology
Antiulcer drugs, Prokinetics, antiemetics, anti-diarrheals and drugs for constipation
and irritable bowel syndrome.
Chronopharmacology
Biological and circadian rhythms, applications of chronotherapy in various diseases like
cardiovascular disease, diabetes, asthma and peptic ulcer
Free radicals Pharmacology
Generation of free radicals, role of free radicals in etiopathology of various diseases
such as diabetes, neurodegenerative diseases and cancer. Protective activity of certain important antioxidant
Recent Advances in Treatment:
Alzheimer’s disease, Parkinson’s disease, Cancer, Diabetes mellitus
12
Hrs

12
Hrs

REFERENCES
1. The Pharmacological basis of therapeutics- Goodman and Gill man‘s
2. Principles of Pharmacology. The Pathophysiologic basis of drug therapy by David E Golan et al.
3. Basic and Clinical Pharmacology by B.G -Katzung
4. Pharmacology by H.P. Rang and M.M. Dale.
5. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.
6. Text book of Therapeutics, drug and disease management by E T. Herfindal and Gourley.
7. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu.
8. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists
9. Robbins & Cortan Pathologic Basis of Disease, 9th Ed. (Robbins Pathology)
10. A Complete Textbook of Medical Pharmacology by Dr. S.K Srivastava published by APC Avichal Publishing Company.
11. KD.Tripathi. Essentials of Medical Pharmacology
12. Principles of Pharmacology. The Pathophysiologic basis of drug Therapy by David E Golan, Armen H, Tashjian Jr, Ehrin J,Armstrong, April W, Armstrong, Wolters, Kluwer-Lippincott Williams & Wilkins Publishers

PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II

(MPL 202T)

Scope:

Objectives:

Upon completion of the course, the student shall be able to,

 Explain the various types of toxicity studies.

 Appreciate the importance of ethical and regulatory requirements for toxicity studies.

 Demonstrate the practical skills required to conduct the preclinical toxicity studies.

THEORY 60 Hrs

1. Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive)

Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y

OECD principles of Good laboratory practice (GLP)

History, concept and its importance in drug development

Acute, sub-acute and chronic- oral, dermal and inhalational studies as per OECD guidelines.
Acute eye irritation, skin sensitization, dermal irritation & dermal toxicity studies.
Test item characterization- importance and methods in regulatory toxicology studies
Reproductive toxicology studies, Male reproductive toxicity studies, female reproductive studies (segment I and segment III), teratogenecity studies (segment II)
Genotoxicity studies (Ames Test, in vitro and in vivo Micronucleus
and Chromosomal aberrations studies)
In vivo carcinogenicity studies
IND enabling studies (IND studies)- Definition of IND, importance of IND, industry perspective, list of studies needed for IND submission.
12
Hrs

12
Hrs

12
Hrs

12
Hrs
Safety pharmacology studies- origin, concepts and importance of safety pharmacology.
Tier1- CVS, CNS and respiratory safety pharmacology, HERG assay. Tier2- GI, renal and other studies
Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies.
Alternative methods to animal toxicity testing.
12
Hrs

REFERENCES
1. Hand book on GLP, Quality practices for regulated non-clinical research and development (http://www.who.int/tdr/publications/documents/glp- handbook.pdf).
2. Schedule Y Guideline: drugs and cosmetics (second amendment) rules,
  2005, ministry of health and family welfare (department of health) New Delhi
3. Drugs from discovery to approval by Rick NG.
4. Animal Models in Toxicology, 3rd Edition, Lower and Bryan
5. OECD test guidelines.
6. Principles of toxicology by Karen E. Stine, Thomas M. Brown.
7. Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinform ation/guidances/ucm073246.pdf)

PRINCIPLES OF DRUG DISCOVERY (MPL 203T)

Scope:

The subject imparts basic knowledge of drug discovery process. This information will make the student competent in drug discovery process

Objectives:

Upon completion of the course, the student shall be able to,

 Explain the various stages of drug discovery.

 Appreciate the importance of the role of genomics, proteomics and bioinformatics in drug discovery

 Explain various targets for drug discovery.

 Explain various lead seeking method and lead optimization

 Appreciate the importance of the role of computer aided drug design in drug discovery

THEORY 60 Hrs

1. An overview of modern drug discovery process: Target identification, target validation, lead identification and lead Optimization. Economics of drug discovery.

Lead Identification- combinatorial chemistry & high throughput screening, in silico lead discovery techniques, Assay development for hit identification.
Protein structure
Levels of protein structure, Domains, motifs, and folds in protein structure. Computational prediction of protein structure: Threading and homology modeling methods. Application of NMR and X-ray crystallography in protein structure prediction
Rational Drug Design
Traditional vs rational drug design, Methods followed in traditional drug design, High throughput screening, Concepts of Rational Drug Design, Rational Drug Design Methods: Structure and Pharmacophore based approaches
12
Hrs

12
Hrs

12
Hrs
Virtual Screening techniques: Drug likeness screening, Concept of pharmacophore mapping and pharmacophore based Screening,
Molecular docking: Rigid docking, flexible docking, manual docking; Docking based screening. De novo drug design. Quantitative analysis of Structure Activity Relationship
History and development of QSAR, SAR versus QSAR, Physicochemical parameters, Hansch analysis, Fee Wilson analysis and relationship between them.
QSAR Statistical methods – regression analysis, partial least square analysis (PLS) and other multivariate statistical methods. 3D-QSAR approaches like COMFA and COMSIA
Prodrug design-Basic concept, Prodrugs to improve patient acceptability, Drug solubility, Drug absorption and distribution, site specific drug delivery and sustained drug action. Rationale of prodrug design and practical consideration of prodrug design

12
Hrs

12
Hrs

REFERENCES
1. MouldySioud. Target Discovery and Validation Reviews and Protocols: Volume 2 Emerging Molecular Targetsand Treatment Options. 2007 Humana Press Inc.
2. Darryl León. Scott MarkelIn. Silico Technologies in Drug Target Identification and Validation. 2006 by Taylor and Francis Group, LLC.
3. Johanna K. DiStefano. Disease Gene Identification. Methods and Protocols. Springer New York Dordrecht Heidelberg London.
4. Hugo Kubiny. QSAR: Hansch Analysis and Related Approaches. Methods and Principles in Medicinal Chemistry. Publisher Wiley-VCH
5. Klaus Gubernator, Hans-Joachim Böhm. Structure-Based Ligand Design. Methods and Principles in Medicinal Chemistry. Publisher Wiley-VCH
6. Abby L . Parrill. M . Rami Reddy. Rational Drug Design. Novel Methodology and Practical Applications. ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
7. J. Rick Turner. New drug development design, methodology and, analysis. John Wiley & Sons, Inc., New Jersey.

CLINICAL RESEARCH AND PHARMACOVIGILANCE (MPL 204T)

Scope:

Objectives:

Upon completion of the course, the student shall be able to,

 Explain the regulatory requirements for conducting clinical trial

 Demonstrate the types of clinical trial designs

 Explain the responsibilities of key players involved in clinical trials

 Execute safety monitoring, reporting and close-out activities

 Explain the principles of Pharmacovigilance

 Detect new adverse drug reactions and their assessment

 Perform the adverse drug reaction reporting systems and communication in Pharmacovigilance

THEORY 60 Hrs

1. Regulatory Perspectives of Clinical Trials:

Origin and Principles of International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines Ethical Committee: Institutional Review Board, Ethical

Hrs

	Guidelines for Biomedical Research and Human Participant-
	Schedule Y, ICMR
	Informed Consent Process: Structure and content of an
	Informed Consent Process Ethical principles governing informed
	consent process
2	Clinical Trials: Types and Design	12
	Experimental Study- RCT and Non RCT,	Hrs
	Observation Study: Cohort, Case Control, Cross sectional Clinical Trial Study Team
	Roles and responsibilities of Clinical Trial Personnel: Investigator,
	Study Coordinator, Sponsor, Contract Research Organization and
	its management

Clinical Trial Documentation- Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring- Safety Monitoring in CT
Adverse Drug Reactions: Definition and types. Detection and reporting methods. Severity and seriousness assessment.Predictability and preventability assessment, Management of adverse drug reactions; Terminologies of ADR.
Basic aspects, terminologies and establishment of pharmacovigilance
History and progress of pharmacovigilance, Significance of safety monitoring, Pharmacovigilance in India and international aspects, WHO international drug monitoring programme, WHO and Regulatory terminologies of ADR, evaluation of medication safety, Establishing pharmacovigilance centres in Hospitals, Industry and National programmes related to pharmacovigilance. Roles and responsibilities in Pharmacovigilance
Methods, ADR reporting and tools used in Pharmacovigilance
International classification of diseases, International Non- proprietary names for drugs, Passive and Active surveillance, Comparative observational studies, Targeted clinical investigations and Vaccine safety surveillance. Spontaneous reporting system and Reporting to regulatory authorities, Guidelines for ADRs reporting. Argus, Aris G Pharmacovigilance, VigiFlow, Statistical methods for evaluating medication safety data.
Pharmacoepidemiology, pharmacoeconomics, safety pharmacology
12
Hrs

12
Hrs

12
Hrs

12
Hrs

REFERENCES
1. Central Drugs Standard Control Organization- Good Clinical Practices, Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;2001.
2. International Conference on Harmonization of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice.E6; May 1996.
3. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.
4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons.
5. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications.
6. Handbook of clinical Research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone.
7. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.

PHARMACOLOGICAL PRACTICAL - II (MPL 205P)

To record the DRC of agonist using suitable isolated tissues preparation.
To study the effects of antagonist/potentiating agents on DRC of agonist using suitable isolated tissue preparation.
To determine to the strength of unknown sample by matching bioassay by using suitable tissue preparation.
To determine to the strength of unknown sample by interpolation bioassay by using suitable tissue preparation
To determine to the strength of unknown sample by bracketing bioassay by using suitable tissue preparation
To determine to the strength of unknown sample by multiple point bioassay by using suitable tissue preparation.
Estimation of PA2 values of various antagonists using suitable isolated tissue preparations.
To study the effects of various drugs on isolated heart preparations
Recording of rat BP, heart rate and ECG.
Recording of rat ECG
Drug absorption studies by averted rat ileum preparation.
Acute oral toxicity studies as per OECD guidelines.
Acute dermal toxicity studies as per OECD guidelines.
Repeated dose toxicity studies- Serum biochemical, haematological, urine analysis, functional observation tests and histological studies.
Drug mutagenicity study using mice bone-marrow chromosomal aberration test.
Protocol design for clinical trial.(3 Nos.)
Design of ADR monitoring protocol.
In-silico docking studies. (2 Nos.)
In-silico pharmacophore based screening.
In-silico QSAR studies.
ADR reporting

REFERENCES

Fundamentals of experimental Pharmacology-by M.N.Ghosh
Hand book of Experimental Pharmacology-S.K.Kulakarni
Text book of in-vitro practical Pharmacology by Ian Kitchen
Bioassay Techniques for Drug Development by Atta-ur-Rahman, Iqbal choudhary and William Thomsen
Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu.
Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists.

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