Experiment No-1

1.0 Aim: Introduction to experimental pharmacology and animal House. 2.0 Course
outcome:

Study of different terms used in the pharmacology animal house & guidelines. 30
Learning objective:

Intellectual Skill To understand the different terms used in pharmacology, animals,

animal house criteria in

pharmacology laboratory Motor Skill

Ability to understand different skills to be used in pharmacology

4.0 Introduction: 4.1 Pharmacology:

It is science in which the effect of drug is studied on living body. The word
pharmacology’ is derived from the Greek words pharmakon meaning a drug or poison
and logos meaning discourse or study. It also defined as the effect or mechanism of
action of drug on the living organism.

42 Drug:

Drug is a chemical substance used in the diagnosis, prevention, treatment or cure of a

disease or disorder in human beings or animals.

43 Experimental Pharmacology:

It involves the discovery of new drugs or to study the actions of existing drugs in human
and

The main aims of the experimental pharmacology are to

Find out a therapeutic agent suitable for human use

Study the toxicity of a drug

3 Study the mechanism of action of drugs

Two main stages in experimental pharmacology L Preclinical experimental

pharmacology:

which involves the identification and optimization of novel chemical lead structures and
testing them on animals and animal tissues or organs for their biological actions

Clinical pharmacology:

where testing of drugs is done on human volunteers and patients for assessing the

pharmacokinetics, safety and efficacy in humans

4.4 Branches of pharmacology:

Preclinical pharmacology Pharmacokinetics, Pharmacodynamics, Pharmacotherapeutics,

Pharmacoepidemiology, Pharmacoeconomics, Toxicology, Clinical pharmacology.
Experiment No-1

1.0 Aim: Introduction to experimental pharmacology and animal House. 2.0 Course
outcome:

Study of different terms used in the pharmacology animal house & guidelines. 30
Learning objective:
Intellectual Skill To understand the different terms used in pharmacology, animals,
animal house criteria in

pharmacology laboratory Motor Skill

Ability to understand different skills to be used in pharmacology

4.0 Introduction: 4.1 Pharmacology:

It is science in which the effect of drug is studied on living body. The word
pharmacology' is derived from the Greek words pharmakon meaning a drug or poison
and logos meaning discourse or study. It also defined as the effect or mechanism of
action of drug on the living organism.

42 Drug:

Drug is a chemical substance used in the diagnosis, prevention, treatment or cure of a

disease or disorder in human beings or animals.

43 Experimental Pharmacology:

It involves the discovery of new drugs or to study the actions of existing drugs in human
and

The main aims of the experimental pharmacology are to

Find out a therapeutic agent suitable for human use

Study the toxicity of a drug

2
3 Study the mechanism of action of drugs

Two main stages in experimental pharmacology L Preclinical experimental

pharmacology:

which involves the identification and optimization of novel chemical lead structures and
testing them on animals and animal tissues or organs for their biological actions

Clinical pharmacology:

where testing of drugs is done on human volunteers and patients for assessing the

pharmacokinetics, safety and efficacy in humans

4.4 Branches of pharmacology:

Preclinical pharmacology Pharmacokinetics, Pharmacodynamics, Pharmacotherapeutics,

Pharmacoepidemiology, Pharmacoeconomics, Toxicology, Clinical pharmacology.
Practical Handbook of Pharmacology

15

5.0 Process of Drug discovery:

The Process of Drug Development

Discovery & Development

Preclinical Research
Testing of com

Clinical Research

Safery and affects of by testing it on h

Government Review

mors and carige deta stated to Che cooptand to

Animal House was established at CSIR-IIIM, Jammu for the purpose of conducting
preclinical

Post-Market Safety Montcoring

Drug safety is continuously acoltered ence it is available for use by the public

6.0 Animal House Introduction:

(Animal) or nonclinical studies for Drug Discovery and Drug Development on GLP Mode,
as required for Investigational New Drug applications (IND). This is a well-equipped,
high-standard barrier facility with a ground floor, first floor, and service floor to provide
enough space for activity separation (total covered area is 3304 sq.m.) and the ability to
conduct a number of parallel animal studies. It meets the requirements of the clean
room concept as well as the standards of international and national regulatory agencies
such as GLP, FDA, OECD, CPCSEA, AAALAC, and DCGI. The AH's primary mission is to
breed and maintain various strains of mice, rats, guinea pigs, and rabbits for use by
institutional researchers. Surplus animals are available upon request to government and
non-government organisations registered with CPCSEA.

61 Experimental Approvals:

MEC:

For animal care and use, the institution's veterinarian or institutional animal care or
institute animal ethics committee (IAEC) advises researchers on the use of animals in
their respective research projects.

The IAEC will review and approve all research proposals involving animal experiments in
order to ensure the quality of animal care and welfare while conducting research.
16

CPCSEA

Practical Handbook of Pharmacology

Committee for the control and supervision of animal experiments. All animals must be
obtained legally in accordance with the CPCSEA guidelines. It outlines procedures for
conducting animal experiments and maintaining an animal house. CPCSEA seeks to
ensure that animals are not subjected to unnecessary pain or suffering during, before, or
after experiments on them.The registration of animal house is mandatory with CPCSEA
and is to be renewed every 3 years. There are now some preconditions for renewal by
CPCSEA

7.0 Animal house facility and management 1. Temperature & Humidity:

Animals should be housed within temperature and humidity ranges appropriate for the
species, to which they can adapt with minimal stress and physiologic alteration. The
acceptable

range of relative humidity is 30 to 70%

Mouse, rat, guinea pig: 20-26°C, Rabbit: 16-22°C, Farm animals, poultry: 16-27"C

2. Ventilation:

The primary purpose of ventilation is to provide appropriate air quality and a stable
environment. Specifically, ventilation provides an adequate oxygen supply: removes
thermal loads caused by the animals, personnel, lights, and equipment; dilutes gaseous
and particulate contaminants including allergens and airborne pathogens.

3. Food/feed:

Animals should be fed palatable, non-contaminated, and nutritionally adequate food

daily

unless the experimental protocol requires otherwise.

Animal feed should ensure sufficient content of the six classes of nutrients: water,

carbohydrates, fats (lipids), proteins, minerals, and vitamins

Various feed forms: (a) pellet (rodent). (b) pellet (rabbit), (c) extruded collet (nonhuman

primate), (d) extruded collet (dog), (e) meal, and (f) powdered.

4. Drinking water:

Animals should have access to potable, uncontaminated drinking water according to

their particular requirements. Periodic monitoring for pH, hardness, and microbial or
chemical contamination may be necessary to ensure that water quality is acceptable.

5. Cages for animals:

The caging or housing system is one of the most important elements. It should be
designed
carefully to facilitate animal well being, meet research requirements, and minimize
experimental variables.

Cage heights should take into account typical postures of an animal and provide
adequate

clearance for normal cage components, such as feeders and water devices, including
sipper tubes. Rodents are often housed on wire flooring, which enhances sanitation of
the cage by enabling urine and feces to pass through to a collection tray. Solid-bottom
caging, with bedding, is therefore recommended for rodents. Vinyl-coated flooring is
often used for other species, such as dogs and nonhuman primates

6. Different section or Layout of animal house: The design and size of an animal facility
depend on the scope of institutional research activities, the animals to be housed, some
functional area.

S
Nactical Handbook of Pharmacology

17

should be designed hur ved bedding, cages and materials not in use, Anava ranting
cages and ancillary equipment is essential with adequate water supply

Experimental areas all experimental procedures in small animals should be carried out in
a separate area away

wom the place where animals are housed

Functional areas for aseptic surgery should include a separate surgical support area,
preparation are the operating room or rooms, and an area for intensive care and
supportive

Showers sinks lockers and toilets for personnel Food and bedding and separate areas
For holding soiled and cleaned equipment

An area for repairing cages and equipment

8.0 Write answers the following questions?

What is experimental pharmacology?

State the main aims of the experimental pharmacology. Name and discuss different
branches of pharmacology

Which are the two main stages in experimental pharmacology?

& State the different section in animal house Which experimental approvals are
necessary for conducting experimentation on

animals

7. Mention the role of IABC & CPCSAR in experimental pharmacology Mention the
stages involved in experimental pharmacology

Explain the phases of drug development. 10 Explain animal house facilities and
management for animal house.