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

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