Pharm D Revised Regulations 2008 - Rajiv Gandhi University of ...

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78Theory : 2 Hrs. /Week4.6 CLINICAL TOXICOLOGY (THEORY)1. General principles involved in the management of poisoning2. Antidotes and the clinical applications.3. Supportive care in clinical Toxicology.4. Gut Decontamination.5. Elimination Enhancement.6. Toxicokinetics.7. Clinical symptoms and management of acute poisoning with the following agents –a) Pesticide poisoning: organophosphorous compounds, carbamates,organochlorines, pyrethroids.b) Opiates overdose.c) Antidepressantsd) Barbiturates and benzodiazepines.e) Alcohol: ethanol, methanol.f) Paracetamol and salicylates.g) Non-steroidal anti-inflammatory drugs.h) Hydrocarbons: Petroleum products and PEG.i) Caustics: inorganic acids and alkali.j) Radiation poisoning8. Clinical symptoms and management of chronic poisoning with the following agents –Heavy metals: Arsenic, lead, mercury, iron, copper9. Venomous snake bites: Families of venomous snakes, clinical effects of venoms,general management as first aid, early manifestations, complications and snakebite injuries.10. Plants poisoning. Mushrooms, Mycotoxins.11. Food poisonings12. Envenomations – Arthropod bites and stings.Substance abuse:Signs and symptoms of substance abuse and treatment of dependencea) CNS stimulants :amphetamineb) Opioidsc) CNS depressantsd) Hallucinogens: LSDe) Cannabis groupf) TobaccoReferences:a. Matthew J Ellenhorn. ELLENHORNS MEDICAL TOXICOLOGY – DIAGNOSISAND TREATMENT OF POISONING. Second edition. Williams and Willkinspublication, Londonb. V V Pillay. HANDBOOK OF FORENSIC MEDICINE AND TOXICOLOGY.Thirteenth edition 2003 Paras Publication, Hyderabad
79Fifth yearTheory : 3 Hrs. /Week5.1 CLINICAL RESEARCH (THEORY)1. Drug development process:IntroductionVarious Approaches to drug discovery1. Pharmacological2. Toxicological3. IND Application4. Drug characterization5. Dosage form2. Clinical development of drug:1. Introduction to Clinical trials2. Various phases of clinical trial.3. Methods of post marketing surveillance4. Abbreviated New Drug Application submission.5. Good Clinical Practice – ICH, GCP, Central drug standard control organisation(CDSCO) guidelines6. Challenges in the implementation of guidelines7. Ethical guidelines in Clinical Research8. Composition, responsibilities, procedures of IR B / IEC9. Overview of regulatory environment in USA, Europe and India.10. Role and responsibilities of clinical trial personnel as per ICH GCPa. Sponsorb. Investigatorsc. Clinical research associated. Auditorse. Contract research coordinatorsf. Regulatory authority11. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)12. Informed consent Process13. Data management and its components14. Safety monitoring in clinical trials.
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1RAJIV GANDHI UNIVERSITY OF HEALTH
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3Second Year:S.No Name of Subject N
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Sixth Year:5Internship or residency
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7Second Year examination :S.No. Nam
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12. Declaration of Class9Class shal
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11(v) Final evaluation of project w
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151.1 HUMAN ANATOMY & PHYSIOLOGY (P
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Theory : 2 Hrs. /Week171.2 PHARMACE
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195. Linimentsa. Liniment of turpen
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214 Lipid metabolism: Oxidation of
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231.4 PHARMACEUTICAL ORGANIC CHEMIS
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2512 Mechanism of aldol condensatio
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