introduction bio ethics and preclinical and clinical trial by srota dawn
DESCRIPTION
its an introduction to the bioethics related to preclinical and clinical studies.TRANSCRIPT
BIO-ETHICS
BySROTA DAWN
M.PHARM(PHARMACOLOGY)
INTRODUCTION:
The term bioethics formed by two different words
Biology+
EthicsBiology :
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
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 GreeceActual meaning of Bioethics [Greek ] bios ~ life; ethos~ behavior)
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).
Ethics
BioethicsClinical Ethics
Research ethics
Resource Allocation ethics
Public Health ethics
Nursing ethics
other
Business ethics
Environmental ethics
Social ethics
Organizational ethics
IT ethics
Other
Research ethics
Preclinical study related ethics
Clinical study related cthics
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.
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
Laboratory animalRodents Mouse
Rat
Guinea pig
Hamster
Rabbit
Larger animalCat
Dog
Human primates
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
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
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
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 INSTITUTE1 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
CPCSEA guidelines
1. Veterinary care2. Animal procurement3. Quarantine, stabilization and separation of animals4. Animal experiments using hazardous chemicals5. Multiple surgical procedures on single animal6. Duration of experiments7. Physical restraint8. Physical plant 9. Physical relationship of animal facilities to
laboratories10.Functional areas11.Physical facilities12.Environment13.Animal husbandry• Caging or housing system• Sheltered or outdoor housing• Social environment14.Activity15.Food16.bedding
17.Water18.Sanitization and cleanliness19.Assessing the effectiveness of sanitization20.Waste disposal21.Pest control22.Emergency, weekend and holiday care23.Record keeping24.Standard operating procedures25.Personal training26.Transport of laboratory animals27.Anaesthesia and uthanesia
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
Clinical trialPhase IHUMAN PHARMACOLOGY
AND SAFETY
Phase IITHERAPE
UTIC EXPLORA
TION AND
DODE RANGEIN
G
Phase IIITHERAPE
UTIC CONFORMATION
AND COMPARI
SON
Phase IVPOST
MARKETING
SERVEILLANCE
Thank you