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

PROTEINS AND PROTEIN FORMULATIONS (MPB 201T)

Scope

This course is designed to impart knowledge and skills necessary for knowing fundamental aspects of proteins and their formulations is a part of drug research and development process. Basic theoretical discussions of the principles of more integrated and coherent use of information for protein formulation and design are provided to help the students to clarify the various biological concepts of protein.

Objective

At the completion of this course it is expected that students will be able to understand,

 Various methods of purification of proteins

 Peptides in drug development

 Protein identification and characterization

 Protein based formulations

 Sequencing proteins

THEORY 60 Hrs

1. Protein engineering

Concepts for protein engineering. Isolation and purification of proteins, Stability and activity based approaches of protein engineering, Chemical and Physical Considerations in Protein and Peptide Stability, Different methods for protein engineering, gene shuffling, and direct evolution.

Peptidomimetics
Introduction, classification; Conformationally restricted peptides, design, pseudopeptides, peptidomimetics and transition state analogs; Biologically active template; Amino acid replacements; Peptidomimetics and rational drug design; CADD techniques in peptidomimetics; Development of non peptide peptidomimetics.
Proteomics
Protein identification and characterization: Methods/strategies, protein identification, de novo protein characterization, Isotope labelling, N- and C-terminal tags.

12
Hrs

12
Hrs

12
Hrs
2-Dimensional gel electrophoresis
Methods including immobilized pH gradients (IPGs), resolution, reproducibility and image analysis, future developments
Protein formulation
Different strategies used in the formulation of DNA and proteins, Analytical and biophysical parameters of proteins and DNA in pre- formulation, Liposomes, Neon-spears, Neon-particulate system, PEGylation, Biological Activity, Biophysical Characterization Techniques, Forced degradation studies of protein.
Methods of protein sequencing
Various methods of protein sequencing, characterisation, Edman degradation, Tryptic and/or Chymotryptic Peptide Mapping.

12
Hrs

12
Hrs

REFERENCES
1. H. Lodhishet. Al. Molecular Cell Biology, W. H. Freeman and Company
2. Protein Purification – Hand Book, Amersham pharmacia biotech
3. EngelbertBuxbaum, Fundamentals of Protein Structure and Function, Springer Science
4. Sheldon J. Park, Jennifer R. Cochran, Protein Engineering and Design, CRC press.
5. Robert K. Skopes. Protein purification, principle and practice, springer link.
6. David Whitford, Proteins-Structure and Function, John Wiley & Sons Ltd.
7. James Swarbrick, Protein Formulation and Delivery Informa Healthcare USA,Inc.
8. Rodney Pearlman, Y. John Wang Formulation, Characterization, and Stability of Protein Drugs, Kluwer Academic Publishers.

IMMUNOTECHNOLOGY (MPB 202T)

Scope

This course is designed to impart knowledge on production and engineering of antibodies, the application of antigens, the design of (recombinant) vaccines, strategies for immune intervention, etc. The Immunotechnology - based techniques will be used for therapeutics and diagnostics, industries in the production, quality control and quality assurance, and in R&D.

Objective

After this course, the students will be able to:-

 Understand the techniques like immunodiagnostic tests,

 Characterization of lymphocytes, purification of antigens and antibody, etc.

 Access health problems with immunological background;

 Develop approaches for the immune intervention of diseases

THEORY 60 Hrs

1. Fundamental aspects of immunology

Introduction, cells and organs of the immune system, cellular basis of Immune response, primary and secondary lymphoid organs, antigen antibody and their structure.

Types of immune responses, anatomy of immune response. Overview of innate and adaptive Immunity.

Humoral Immunity

B – Lymphocytes and their activation. Structure and function of immunoglobulins, idiotypes and anti idiotypic antibodies.

Cell mediated Immunity

Thymus derived lymphocytes (T cells) – their ontogeny and types, MHC complex, antigen presenting cells (APC), mechanisms of T cell activation, macrophages, dendritic cells, langerhans cells, mechanism of phagocytosis

Immune Regulation and Tolerance
Complement activation and types and their biological functions, cytokines and their role in immune response.

Hypersensitivity
Hypersensitivity Types I-IV, Hypersensitivity reactions and treatment
Autoimmune diseases
12
Hrs

12
Hrs
Vaccine technology
Vaccine and their types, conventional vaccines, novel methods for vaccine production, antiidiotype vaccine, DNA vaccine, genetically engineered vaccine, iscoms, synthetic peptides, and immunodiagnostics.
Stem cell technology
Stem cell technology and applications to immunology
Hybridoma Technology
Hybridoma techniques – fusion methods for myeloma cells and B- Lymphocytes, selection and screening techniques. Production and purification of monoclonal antibodies and their applications in Pharmaceutical industry.
Immunological Disorder
Autoimmune disorders and types, pathogenic mechanisms, treatment, experimental models of auto immune diseases, primary and secondary immunodeficiency disorders.
Immunodiagnosis
Antigen antibody interaction – Precipitation reaction, Agglutination reactions, Principles and applications of ELISA, Radio Immuno Assay, Western blot analysis, immune-electrophoresis, immuno fluorescence, chemiluminescence assay, complement fixation reaction.
12
Hrs

12
Hrs

12
Hrs

REFERENCES
1. J. Kubey, Immunology – an Introduction.
2. S.C. Rastogi, Immunodiagonstics, New Age International.
3. Ashim Chakravarthy, Immunology and Immunotechnology, Oxford University Press.
4. E. Benjamini, Molecular Immunology.

BIOINFORMATICS AND COMPUTATIONAL BIOTECHNOLOGY (MPB 203T)

Scope

This paper has been designed to provide the advanced knowledge to the biotechnology students in invaluable areas of advanced bioinformatics which plays a crucial role in determining its future use and applications in medicine, drug discovery and in pharmaceutical industry.

Objectives

Upon completion of this course it is expected that the students will be able to understand,

 Use of computers in developing a new drugs

 Biological concepts for bioinformatics

 Proteins and their diversity

 Various gene finding methods

 Searching the biological databases

 Target searching

 Various methods of drug designing

THEORY 60 Hrs

1. Introduction to Bioinformatics

Definition and History of Bioinformatics, Internet and Bioinformatics, Introduction to Data Mining, Applications of Data Mining to Bioinformatics,

Biological Database

Protein and nucleic acid databases. Structural data bases. Collecting and storing the sequence and Applications of Bioinformatics.

Sequence analysis
Sequence alignment, pair wise alignment techniques, multiple sequence analysis, multiple sequence alignment; Flexible sequence similarity searching with the FAST3 program package, the use of CLUSTAL W and CLUSTAL X for the multiple sequence alignment. Tools used for sequence analysis.
Protein informatics
Introduction; Force field methods; Energy, buried and exposed residues, side chains and neighbours; Fixed regions, hydrogen bonds, mapping properties onto surfaces; Fitting monomers, R &
12
Hrs

12
Hrs

12
Hrs
S fit of conformers, assigning secondary structures; Sequence alignment-methods, evaluation, scoring; Protein completion, backbone construction and side chain addition; Small peptide methodology, software accessibility, building peptides; Protein displays; Substructure manipulations, annealing.
Protein structure prediction
Protein folding and model generation; Secondary structure prediction, analyzing secondary structures; Protein loop searching, loop generating methods, loop analysis; Homology modeling, concepts of homology modeling, potential applications, description, methodology, homologous sequence identification; Align structures, align model sequence; Construction of variable and conserved regions, threading techniques, Topology fingerprint approach for prediction, evaluation of alternate models; Structure prediction on a mystery sequence, structure aided sequence techniques of structure prediction, structural profiles, alignment algorithms, mutation tables, prediction, validation, sequence based methods of structure prediction, prediction using inverse folding, fold prediction; Significance analysis, scoring techniques, sequence- sequence scoring.
Docking
Docking problems, methods for protein- ligand docking, validation studies and applications; Screening small molecule databases, docking of combinatorial libraries, input data, analyzing docking results.
Diversity of Genomes
Prokaryotic and Eukaryotic Gene Families. Genome Analysis: Introduction, Gene prediction methods, Gene mapping and applications- Genetic and Physical Mapping, Integrated map, Sequence assembly and gene expression.
Completed Genomes
Bacterium, Nematode, Plant and Human
Evolution of Genomes
Lateral or Horizontal Transfer among Genomes, Transcriptome and Proteome-General Account
Phylogenetic analysis
Evolutionary Change in Nucleotide Sequences, Rates and Patterns of Nucleotide Substitution, Models for Nucleotide Substitution, Construction of Phylogenetic Tree, Genome Annotation technique.
12
Hrs
Target searching and Drug Designing
Target and lead, timeline for drug development, target discovery, target modulators, In-silico gene expression, microarray, and lead discovery, libraries of ligands, active site analysis, and prediction of drug quality.
12
Hrs

REFERENCES
1. David W. Mount, Bioinformatics Sequence and Genome Analysis, CBS Publishers and Distributors
2. S. C. Rastogiet. al. Bioinformatics- Concepts Skill and Applications, CBS Publishers and Distributors
3. T. E. Creighton, Protein Structure and Molecular Properties, W.
  H.Freeman and Company
4. Andreas D. Baxevanis, B. F. Francis Ouellette, Bioinformatics; A Practical Guide to the Analysis of Genes and Proteins, John Wiley & Sons, Inc.
5. Arthur M. Lesk, Introduction to Bioinformatics, Oxford University Press.
6. Shui Qing Ye. Bioinformatics: A Practical Approach, Chapman & Hall/CRC.
7. David Posada, Bioinformatics for DNA Sequence Analysis, Humana press.
8. Lesk, A.M. Introduction to Bioinformatics. Oxford University Press.
9. Letovsky, S.I. Bioinformatics. Kluwer Academic Publishers. 10.Baldi, P. and Brunak, S. Bioinformatics. The MIT Press.

BIOLOGICAL EVALUATION OF DRUG THERAPY (MPB 204T)

Scope

This paper has been designed to provide the knowledge to the biotechnology students to understand the importance of biological and evaluation of drug therapy of biological medicines.

Objective

At the completion of this subject it is expected that students will be able to,

 Understand about the general concept of standardization of biological.

 Understand the importance of transgenic animals and knockout animals.

 Understand the biological medicines in development of various diseases.

 Learn the biological evaluation of drugs in vitro and in vivo

THEORY 60 Hrs

1. Biological Standardization

General principles, Scope and limitation of bio-assay, bioassay of some official drugs.

Preclinical drug evaluation

Preclinical drug evaluation of its biological activity, potency and toxicity-Toxicity test in animals including acute, sub-acute and chronic toxicity, ED50 and LD50 determination, special toxicity test like teratogenecity and mutagenecity.

Guidelines for toxicity studies

Various guidelines for toxicity studies. Animal experiments assessing safety of packaging materials.

Pyrogens
Pyrogens: Sources, Chemistry and properties of bacterial pyrogens and endotoxins, Official pyrogen tests.
Microbiological assay
Assay of antibiotics and vitamins.
Biological evaluation of drugs
Screening and evaluation (including principles of screening, development of models for diseases: In vivo models / In vitro models / cell line study).
12
Hrs

12
Hrs
Biologic Medicines in Development for various diseases - By Therapeutic Category
 Genetic Disorders
 Eye related Disorders
 Digestive Disorders
 Diabetes/Related Conditions
 Cardiovascular Disease
 Cancer/Related Conditions
 Blood Disorders
 Autoimmune Disorders
 Infectious Diseases
 Neurologic Disorders
 Skin Diseases
 Organe Transplantation

Biologic Medicines in Development for various diseases – by Product Category
 Antisense
 Vaccines
 Recombinant Hormones/Proteins
 Monoclonal Antibodies (mAb)
 Interferons
 Growth Factors
 Gene Therapy
 RNA Interference
Regulatory aspects : drugs, biologics and medical devices An introduction to the regulations and documents necessary for approval of a medical product.
Regulatory consideration
Regulatory consideration for pre-clinical testing and clinical testing of drugs, biologics and medical devices.
New Drug Applications for Global Pharmaceutical Product Approvals
Bioavailability
Objectives and consideration in bio-availability studies of Biopharmaceuticals, Concept of equivalents, Measurements of bio-availability.
12
Hrs

12
Hrs

12
Hrs
Determination of the rate of absorption, Bioequivalence and its importance, Regulatory aspects of bio-availability and bioequivalence studies for conventional dosage forms and controlled drug delivery systems of Biopharmaceuticals.
Pharmacokinetics
Pharmacokinetics:- Basic consideration, Pharmacokinetic models, Application of Pharmacokinetics in new drug development of Biopharmaceuticals and designing of dosage forms and Novel drug delivery systems of Biopharmaceuticals.

REFERENCES
1. Perkins F.T., Hennessen W. Standardization and Control of Biologicals Produced by Recombinant DNA Technology, International Association of Biological Standardization
2. J.H. Burn., Biological Standardization, Oxford University Press
3. Drug Discovery and Evaluation in Pharmacology assay: Vogel
4. Chow, Shein, Ching, Design and analysis of animal studies in pharmaceutical development,
5. Nodine and Siegler, Animal and Clinical pharmacologic Techniques in Drug Evaluation.
6. Screening methods in pharmacology (vol I & II), R.A. Turner.

PHARMACEUTICAL BIOTECHNOLOGY PRACTICAL - II (MPB 205P)

Protein identification
Protein characterization
Protein biochemistry
Recombinant DNA Technology
Protein expression
Protein formulations
Database searching
Sequence analysis methods
Protein structure prediction
Gene annotation methods
Phylogenetic analysis
Protein, DNA binding studies
Preparation of DNA for PCR applications – Isolation, Purity and Quantification
Introduction to PCR – working of PCR, Programming.
Introduction to RT-PCR – working, programming.
Primer design using softwares.
Gene DNA amplification by random / specific primers.
Southern Hybridization
Western Blotting
Gene transformation

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

PROTEINS AND PROTEIN FORMULATIONS (MPB 201T)

Scope

Objective

At the completion of this course it is expected that students will be able to understand,

 Various methods of purification of proteins

 Peptides in drug development

 Protein identification and characterization

 Protein based formulations

 Sequencing proteins

THEORY 60 Hrs

1. Protein engineering

Peptidomimetics
Introduction, classification; Conformationally restricted peptides, design, pseudopeptides, peptidomimetics and transition state analogs; Biologically active template; Amino acid replacements; Peptidomimetics and rational drug design; CADD techniques in peptidomimetics; Development of non peptide peptidomimetics.
Proteomics
Protein identification and characterization: Methods/strategies, protein identification, de novo protein characterization, Isotope labelling, N- and C-terminal tags.

12
Hrs

12
Hrs

12
Hrs
2-Dimensional gel electrophoresis
Methods including immobilized pH gradients (IPGs), resolution, reproducibility and image analysis, future developments
Protein formulation
Different strategies used in the formulation of DNA and proteins, Analytical and biophysical parameters of proteins and DNA in pre- formulation, Liposomes, Neon-spears, Neon-particulate system, PEGylation, Biological Activity, Biophysical Characterization Techniques, Forced degradation studies of protein.
Methods of protein sequencing
Various methods of protein sequencing, characterisation, Edman degradation, Tryptic and/or Chymotryptic Peptide Mapping.

12
Hrs

12
Hrs

REFERENCES
1. H. Lodhishet. Al. Molecular Cell Biology, W. H. Freeman and Company
2. Protein Purification – Hand Book, Amersham pharmacia biotech
3. EngelbertBuxbaum, Fundamentals of Protein Structure and Function, Springer Science
4. Sheldon J. Park, Jennifer R. Cochran, Protein Engineering and Design, CRC press.
5. Robert K. Skopes. Protein purification, principle and practice, springer link.
6. David Whitford, Proteins-Structure and Function, John Wiley & Sons Ltd.
7. James Swarbrick, Protein Formulation and Delivery Informa Healthcare USA,Inc.
8. Rodney Pearlman, Y. John Wang Formulation, Characterization, and Stability of Protein Drugs, Kluwer Academic Publishers.

IMMUNOTECHNOLOGY (MPB 202T)

Scope

Objective

After this course, the students will be able to:-

 Understand the techniques like immunodiagnostic tests,

 Characterization of lymphocytes, purification of antigens and antibody, etc.

 Access health problems with immunological background;

 Develop approaches for the immune intervention of diseases

THEORY 60 Hrs

1. Fundamental aspects of immunology

Introduction, cells and organs of the immune system, cellular basis of Immune response, primary and secondary lymphoid organs, antigen antibody and their structure.

Types of immune responses, anatomy of immune response. Overview of innate and adaptive Immunity.

Humoral Immunity

B – Lymphocytes and their activation. Structure and function of immunoglobulins, idiotypes and anti idiotypic antibodies.

Cell mediated Immunity

Immune Regulation and Tolerance
Complement activation and types and their biological functions, cytokines and their role in immune response.

Hypersensitivity
Hypersensitivity Types I-IV, Hypersensitivity reactions and treatment
Autoimmune diseases
12
Hrs

12
Hrs
Vaccine technology
Vaccine and their types, conventional vaccines, novel methods for vaccine production, antiidiotype vaccine, DNA vaccine, genetically engineered vaccine, iscoms, synthetic peptides, and immunodiagnostics.
Stem cell technology
Stem cell technology and applications to immunology
Hybridoma Technology
Hybridoma techniques – fusion methods for myeloma cells and B- Lymphocytes, selection and screening techniques. Production and purification of monoclonal antibodies and their applications in Pharmaceutical industry.
Immunological Disorder
Autoimmune disorders and types, pathogenic mechanisms, treatment, experimental models of auto immune diseases, primary and secondary immunodeficiency disorders.
Immunodiagnosis
Antigen antibody interaction – Precipitation reaction, Agglutination reactions, Principles and applications of ELISA, Radio Immuno Assay, Western blot analysis, immune-electrophoresis, immuno fluorescence, chemiluminescence assay, complement fixation reaction.
12
Hrs

12
Hrs

12
Hrs

REFERENCES
1. J. Kubey, Immunology – an Introduction.
2. S.C. Rastogi, Immunodiagonstics, New Age International.
3. Ashim Chakravarthy, Immunology and Immunotechnology, Oxford University Press.
4. E. Benjamini, Molecular Immunology.

BIOINFORMATICS AND COMPUTATIONAL BIOTECHNOLOGY (MPB 203T)

Scope

Objectives

Upon completion of this course it is expected that the students will be able to understand,

 Use of computers in developing a new drugs

 Biological concepts for bioinformatics

 Proteins and their diversity

 Various gene finding methods

 Searching the biological databases

 Target searching

 Various methods of drug designing

THEORY 60 Hrs

1. Introduction to Bioinformatics

Definition and History of Bioinformatics, Internet and Bioinformatics, Introduction to Data Mining, Applications of Data Mining to Bioinformatics,

Biological Database

Protein and nucleic acid databases. Structural data bases. Collecting and storing the sequence and Applications of Bioinformatics.

Sequence analysis
Sequence alignment, pair wise alignment techniques, multiple sequence analysis, multiple sequence alignment; Flexible sequence similarity searching with the FAST3 program package, the use of CLUSTAL W and CLUSTAL X for the multiple sequence alignment. Tools used for sequence analysis.
Protein informatics
Introduction; Force field methods; Energy, buried and exposed residues, side chains and neighbours; Fixed regions, hydrogen bonds, mapping properties onto surfaces; Fitting monomers, R &
12
Hrs

12
Hrs

12
Hrs
S fit of conformers, assigning secondary structures; Sequence alignment-methods, evaluation, scoring; Protein completion, backbone construction and side chain addition; Small peptide methodology, software accessibility, building peptides; Protein displays; Substructure manipulations, annealing.
Protein structure prediction
Protein folding and model generation; Secondary structure prediction, analyzing secondary structures; Protein loop searching, loop generating methods, loop analysis; Homology modeling, concepts of homology modeling, potential applications, description, methodology, homologous sequence identification; Align structures, align model sequence; Construction of variable and conserved regions, threading techniques, Topology fingerprint approach for prediction, evaluation of alternate models; Structure prediction on a mystery sequence, structure aided sequence techniques of structure prediction, structural profiles, alignment algorithms, mutation tables, prediction, validation, sequence based methods of structure prediction, prediction using inverse folding, fold prediction; Significance analysis, scoring techniques, sequence- sequence scoring.
Docking
Docking problems, methods for protein- ligand docking, validation studies and applications; Screening small molecule databases, docking of combinatorial libraries, input data, analyzing docking results.
Diversity of Genomes
Prokaryotic and Eukaryotic Gene Families. Genome Analysis: Introduction, Gene prediction methods, Gene mapping and applications- Genetic and Physical Mapping, Integrated map, Sequence assembly and gene expression.
Completed Genomes
Bacterium, Nematode, Plant and Human
Evolution of Genomes
Lateral or Horizontal Transfer among Genomes, Transcriptome and Proteome-General Account
Phylogenetic analysis
Evolutionary Change in Nucleotide Sequences, Rates and Patterns of Nucleotide Substitution, Models for Nucleotide Substitution, Construction of Phylogenetic Tree, Genome Annotation technique.
12
Hrs
Target searching and Drug Designing
Target and lead, timeline for drug development, target discovery, target modulators, In-silico gene expression, microarray, and lead discovery, libraries of ligands, active site analysis, and prediction of drug quality.
12
Hrs

REFERENCES
1. David W. Mount, Bioinformatics Sequence and Genome Analysis, CBS Publishers and Distributors
2. S. C. Rastogiet. al. Bioinformatics- Concepts Skill and Applications, CBS Publishers and Distributors
3. T. E. Creighton, Protein Structure and Molecular Properties, W.
  H.Freeman and Company
4. Andreas D. Baxevanis, B. F. Francis Ouellette, Bioinformatics; A Practical Guide to the Analysis of Genes and Proteins, John Wiley & Sons, Inc.
5. Arthur M. Lesk, Introduction to Bioinformatics, Oxford University Press.
6. Shui Qing Ye. Bioinformatics: A Practical Approach, Chapman & Hall/CRC.
7. David Posada, Bioinformatics for DNA Sequence Analysis, Humana press.
8. Lesk, A.M. Introduction to Bioinformatics. Oxford University Press.
9. Letovsky, S.I. Bioinformatics. Kluwer Academic Publishers. 10.Baldi, P. and Brunak, S. Bioinformatics. The MIT Press.

BIOLOGICAL EVALUATION OF DRUG THERAPY (MPB 204T)

Scope

This paper has been designed to provide the knowledge to the biotechnology students to understand the importance of biological and evaluation of drug therapy of biological medicines.

Objective

At the completion of this subject it is expected that students will be able to,

 Understand about the general concept of standardization of biological.

 Understand the importance of transgenic animals and knockout animals.

 Understand the biological medicines in development of various diseases.

 Learn the biological evaluation of drugs in vitro and in vivo

THEORY 60 Hrs

1. Biological Standardization

General principles, Scope and limitation of bio-assay, bioassay of some official drugs.

Preclinical drug evaluation

Guidelines for toxicity studies

Various guidelines for toxicity studies. Animal experiments assessing safety of packaging materials.

Pyrogens
Pyrogens: Sources, Chemistry and properties of bacterial pyrogens and endotoxins, Official pyrogen tests.
Microbiological assay
Assay of antibiotics and vitamins.
Biological evaluation of drugs
Screening and evaluation (including principles of screening, development of models for diseases: In vivo models / In vitro models / cell line study).
12
Hrs

12
Hrs
Biologic Medicines in Development for various diseases - By Therapeutic Category
 Genetic Disorders
 Eye related Disorders
 Digestive Disorders
 Diabetes/Related Conditions
 Cardiovascular Disease
 Cancer/Related Conditions
 Blood Disorders
 Autoimmune Disorders
 Infectious Diseases
 Neurologic Disorders
 Skin Diseases
 Organe Transplantation

Biologic Medicines in Development for various diseases – by Product Category
 Antisense
 Vaccines
 Recombinant Hormones/Proteins
 Monoclonal Antibodies (mAb)
 Interferons
 Growth Factors
 Gene Therapy
 RNA Interference
Regulatory aspects : drugs, biologics and medical devices An introduction to the regulations and documents necessary for approval of a medical product.
Regulatory consideration
Regulatory consideration for pre-clinical testing and clinical testing of drugs, biologics and medical devices.
New Drug Applications for Global Pharmaceutical Product Approvals
Bioavailability
Objectives and consideration in bio-availability studies of Biopharmaceuticals, Concept of equivalents, Measurements of bio-availability.
12
Hrs

12
Hrs

12
Hrs
Determination of the rate of absorption, Bioequivalence and its importance, Regulatory aspects of bio-availability and bioequivalence studies for conventional dosage forms and controlled drug delivery systems of Biopharmaceuticals.
Pharmacokinetics
Pharmacokinetics:- Basic consideration, Pharmacokinetic models, Application of Pharmacokinetics in new drug development of Biopharmaceuticals and designing of dosage forms and Novel drug delivery systems of Biopharmaceuticals.

REFERENCES
1. Perkins F.T., Hennessen W. Standardization and Control of Biologicals Produced by Recombinant DNA Technology, International Association of Biological Standardization
2. J.H. Burn., Biological Standardization, Oxford University Press
3. Drug Discovery and Evaluation in Pharmacology assay: Vogel
4. Chow, Shein, Ching, Design and analysis of animal studies in pharmaceutical development,
5. Nodine and Siegler, Animal and Clinical pharmacologic Techniques in Drug Evaluation.
6. Screening methods in pharmacology (vol I & II), R.A. Turner.

PHARMACEUTICAL BIOTECHNOLOGY PRACTICAL - II (MPB 205P)

Protein identification
Protein characterization
Protein biochemistry
Recombinant DNA Technology
Protein expression
Protein formulations
Database searching
Sequence analysis methods
Protein structure prediction
Gene annotation methods
Phylogenetic analysis
Protein, DNA binding studies
Preparation of DNA for PCR applications – Isolation, Purity and Quantification
Introduction to PCR – working of PCR, Programming.
Introduction to RT-PCR – working, programming.
Primer design using softwares.
Gene DNA amplification by random / specific primers.
Southern Hybridization
Western Blotting
Gene transformation

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