Code 205: Plant Biotechnology

Unit 1: Introduction of plant tissue culture and cell suspension culture, physico-chemical conditions for propagation of plant cells and tissues, composition of media, nutrient and hormone requirement, continuous culture, techniques for immobilization of plant cells, continuous product recovery system using immobilized plant cell system. Unit 2: Plant tissue culture product and recovery: Primary and secondary metabolic products (phytochemicals) of plant cells, biosynthesis of secondary metabolites of Biotechnological importance , biotrans ormation for product development and selection of cell culture, process technology ith salient features for specific products. Unit !: Plant tissue culture genetic engineering !a": #tructure and organisation of plant genome, regulation of plant genome e$pression, transcriptional, translational and post transcriptional regulation of plant genome. - %ransposons, chloroplast and mitochondrial genome. Unit ": Plant tissue culture genetic engineering !b": %ransfer of nucleic acid to plant cells - &irect transformation by electroporation and particle gun bombardment. 'grobacterium, %i plasmid vector %heory and techniques for the development of ne herbicide, pesticide, plant pathogens. Unit 5: Plant engineering to ards development of enriched food products, plant gro th regulators, (olecular pharming. Unit #: Introduction to primary and secondary metabolites, important path ay leading to the biosynthesis of secondary metabolites !e.g. serpentine, shin)onin, diosgenin and cardenolids" in plants, Unit $: (etabolic products produced by in vitro culturing of plant cells, selection of plant cells*tissues for the production of a specific product, +ulture system in secondary plant product biosynthesis-batch continuous cultures and immobilized plant cells, biotransformation of precursors by cell culturing. Unit %: ,$traction and analytical methods for the above four metabolites. Industries involved in the production of plant secondary metabolites, Potential and future prospect of the secondary metabolites production by plant cell culture techniques. genetic traits, conferring resistance to

&e't Boo(s: -. +ripeels, (... and #adava, &.,., Plants, /enes and Biotechnology, 0ones and Biotechnology, .ones and Bartlett Publishers ,1*e, 1223 1. Bho 0 ani, #.#., Plant %issue +ulture: 'pplication and 4imitations. 'msterdam, ,lsevier,-552. 3. +hartes, +unningham and 'ndre ..6. Porter, 6ecombinant Proteins from 7lans Production and Isolation of +linically 8seful +ompounds ,9umana Press,-55: ;. Bemard 6./lic) and .ohn ,. %hompson, (ethods in Plant (olecular Biology and Biotechnology, +6+ Press, -553. <. I. Potry)us and /.#pangenberg, /ene %ransfer to Plants !#pinger 4ab (anual", #pinger =erlag, -55:. >. Peter m. /resshoff, Plant /enome 'nalysis: +urrent %opics in Plant (olecular Biology. +6+ Press, -55;. :. .ohn 9ammond, Peter (c/arvey, =idadi ?usibov, Plant Biotechnology: @e 'pplications, #pringer, -555. Products and

)lecti*e +, C-.) 20#: /)0U12&-/3 2442+/5 26. C1+6+C21 &/+215 U6+& 71: +6&/-.UC&+-6 &- C1+6+C21 &/+215: a brief history of clinical trials-- types of clinical trials-- ethics of clinical trials-- +linical %rial Protocols U6+& 72: .)5+06 26. -/026+52&+-6 -4 2 C1+6+C21 &/+21: treatment assignment methods: simple randomisation, bloc)ed randomisation, stratified randomisation of clinical research personnel according to ---minimisation I+9-/+P method- unequal randomisation - the size of a clinical trial-reporting results- 6oles and responsibilities U6+& 7! : 8-6+&-/+60 &/+21 P/-0/)55: +6&/-.UC&+-67 -U&C-8) 8)25U/)5compliance, &ropouts and-Intention-%o-%reat- ' %a$onomy 7f &ropouts- Interim 'nalyses In +linical %rials- /roup #equential Procedures--- ' Bayesian Perspective. 'udits in +linical 6esearch U6+& 7": B25+C 262135)5 -4 C1+6+C21 &/+215: Introduction- Brief 6evie #tatistics-

0enerali9ed 1inear models: 8odels or Counts: &reatment o 4amilial 2denomatous Polyposis (42P) :ith a 6on75teroidal 2nti7+n lammatory .rug 7-rdinal /esponse 8odels:2 Clinical &rial in 1ymphoma 7 8odels :ith parallel 7 6on7parallel models 7 8odel estimation linear predictors7 multiple endpoints- 'nalysis of 4ongitudinal &ata from +linical %rials U6+& 75: ;+5&-/3 -4 /)0U12&-/3 2442+/5, (ain concepts A#,- 6egulatory affairs for studies in human sub0ects- data needed- 4icensing authorities-roles and responsibilities,I+9 -/+P,B&', ,8 +linical %rial- 6egulatory submissions and 6equirements for gaining approval of ne 6egulating control over mar)eting and sales of medical products U6+& 7#: &ocumentation and (aintenance of records. U6+& 7$: &rug C +osmetics 'ct ith special reference to schedule ? and (, schedule of medical products-

devices. +oncept of total quality management, requirements of /(P, /4P, /+P, 6egulatory requirements of drugs and Pharmaceutical !8#B&-@&'* '@&'"

U6+& 7%: +6&)11)C&U21 P/-P)/&3 /+0;&5 patents, %rademar)s, +opyrights, Patents 'ct. &)<& B--=5: -. Dilling, #.D., C #to)er, /ood (anufacturing Practices for Pharmaceuticals, (arcel &e))er, @e ?or). 1. /uarino, 6.'., @e &rug 'pproval Process, (arcel &e))er, @e ?or). 3. &rug C +osmetic 'ct. ;. Patents 'ct. <. Bansol, IP6 /uidelines for Pharm students and 6esearchers. >. Pisano-B&' 6egulatory 'ffairs. :. Phillip D. /rubb, Patents for +hemicals, Pharmaceuticals and Biotechnology E. International +linical %rial, =olume - C1 &ominique P.Brunier and /erhardt @ahler, Interpharm Press, &enver, +olorado 5. +ode of Bederal 6egulation by 8#B&' &o nload -2. I+9-/+P /uidelines &o nload --. Biosafety issues related to genetically modified organism , Biotech +onsortium India 4imited, @e &elhi -1. Brian #. ,veritt., #tatistical 'spects 7f %he &esign 'nd 'nalysis 7f %rials!6evised ,dition" - Dorld #cientific Publishing +linical