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introduction Bio ethics and preclinical and clinical trial by srota dawn

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its an introduction to the bioethics related to preclinical and clinical studies.

its an introduction to the bioethics related to preclinical and clinical studies.

Published in: Education, Business, Spiritual

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  • 1. By SROTA DAWN M.PHARM (PHARMACOLOGY)
  • 2. INTRODUCTION: The term bioethics formed by two different words Biology + Ethics Biology : The scientific study of life and of living organisms. Ethics : A set of principles of right conduct. Motivation based on ideas of right and wrong
  • 3. Definition of Bioethics Bioethics is defined as the study of the ethical and moral implications of new biological discoveries and biomedical advances; mostly in the fields of genetic engineering and drug research. In medicine, it can be found in Hippocratic Oath which was first mentioned in ancient Greece Actual meaning of Bioethics [Greek ] bios ~ life; ethos~ behavior)
  • 4. Why we need bioethics • deciding what we should do (what decisions are morally right or acceptable); • explaining why we should do it (how do we justify our decision in moral terms); and • describing how we should do it (the method or manner of our response when we act on our decision).
  • 5. Ethics Bioethics Clinical Ethics Research ethics Resource Allocation ethics Public Health ethics Nursing ethics other Business ethics Environmental ethics Social ethics Organizational ethics IT ethics Other
  • 6. Research ethics Preclinical study related ethics Clinical study related cthics
  • 7. Preclinical research After synthesising/identifying a prospective compound(s), it is tested on animals to expose its whole pharmacological profile. It is an evaluation process where unfavourable compounds are get rejected in each step, so that only a few out of thousand compounds reach the stage when administration to man (clinical study) is considered.
  • 8. Parameters to be checked in preclinical studies(GLP) • Screening tests • tests on isolated organs, bacterial cultures • test on animal models of human disease • general observational test • confirmatory tests • mechanism of action • systemic pharmacology • quantitative tests • pharmacokinetic studies • toxicity tests • acute • Sub acute • Chronic • special long term toxicity • reproductive toxicity and teratogenicity • mutagenicity • carcinogenicity
  • 9. Laboratory animal Rodents Mouse Rat Guinea pig Hamster Rabbit Larger animal Cat Dog Human primates
  • 10. Legal regulations for the use of animals in preclinical study ‘Russel and Burch’ In their book ‘ The Principles of humane experimental technique ’ (1959) Gave a concept of three ‘R’s Reduction  Refinement  Replacement
  • 11. in INDIA PREVENTION OF CRUELTY TO ANIMALS ACT 1960 Is provided for animal safety during clinical studies CPCSEA was established under that provision CPCSEA is the COMMITTEE FOR THE PURPOSE OF CONTROL AND SUPERVISION OF EXPERIMENTS ON ANIMAL
  • 12. UTILITY OF CPCSEA These guidelines provide a clear idea about the use of animals during experiments using animals. All labs doing animal work had to be registered with the CPCSEA and had to follow a set of rules. The main criteria of this committee is ‘TO PROMOTO HUMANE CARE OF ANIMALS USED FOR EXPERIMENTS’ It provides specifications that will enhance Animal well being
  • 13. members • 1 person from ICMR • 1 person from ICAR Draft committee members • 1 person from biotechnology • 1 person from NATIONAL INSTITUTE OF BIOTECHNOLOGY • 1 person from CENTRAL DRUG RESEARCH INSTITUTE 1 person from INDIAN INSTITUTE OF SCIENCE • 1 Person from ALL INDIA INSTITUTE OF MEDICAL SCIENCE • 1 person from INDIAN VATENARY RESEARCH INSTITUTE • 1 person from RANBAXY INDIA LIMITED • Director of department of biotechnology CPCSEA COMMITTEE MEMBERS Hon. Smt. Maneka Ghandhi (chairperson) Subcommittee members
  • 14. CPCSEA guidelines 1. Veterinary care 2. Animal procurement 3. Quarantine, stabilization and separation of animals 4. Animal experiments using hazardous chemicals 5. Multiple surgical procedures on single animal 6. Duration of experiments 7. Physical restraint 8. Physical plant 9. Physical relationship of animal facilities to laboratories 10. Functional areas 11. Physical facilities 12. Environment 13. Animal husbandry • Caging or housing system • Sheltered or outdoor housing • Social environment 14. Activity 15. Food 16. bedding
  • 15. 17. Water 18. Sanitization and cleanliness 19. Assessing the effectiveness of sanitization 20.Waste disposal 21. Pest control 22. Emergency, weekend and holiday care 23. Record keeping 24. Standard operating procedures 25. Personal training 26. Transport of laboratory animals 27. Anaesthesia and uthanesia
  • 16. Clinical trials when a compound shows significant response in all the tests done in preclinical studies the regulatory authority approaches for investigational new drug(IND)licence. Synthesis/isolation of new molecule purification Preclinical studies IND submission to WHO WHO approval Formulation of dosage form Clinical study in man
  • 17. Clinical trial Phase I HUMAN PHARMACOL OGY AND SAFETY Phase II THERAPEUTIC EXPLORATION AND DODE RANGEING Phase III THERAPEUTIC CONFORMATI ON AND COMPARISON Phase IV POST MARKETING SERVEILLANCE