PHARMACOLOGICAL SCREENING OF DRUG

PRACTICE SCHOOL REPORT SUBMITTED TO

ASSAM SCIENCE AND TECHNOLOGY UNIVERSITY, GUWAHATI, ASSAAM

GIRIJANANDA CHOWDHURY INSTITUTE OF PHARMACEUTICAL SCIENCE,

GUWAHATI.

UNDER THE SUPERVISION OF

Mr. RAJANA JAMES DEPARTMENT OF PHARMACOLOGY
(ASSOCIATE PROFESSOR)
GIPS, GUWAHATI

SUBMITTED BY:
RAKESH KALITA
B PHARM 7TH SEMESTER
REGD. NO : 268805120
ROLL NO : 200510011071
 GIRIJANANDA CHOWDHURY INSTITUTE OF PHARMACEUTICAL SCIENCE
(GIPS)
(A Unit of Shrimanta Shankar Academy)
Approved by AICTE & PCI, New Delhi Affiliated to Assam Science & Technology
University,
N.H.37, Hatkhowapara, Azara, Guwahati – 781017
Telephone:0361-2843405,
E-mail: gipsguwahati@rediffmail.co

CERTIFICATE

This is to certify that the practice school report entitled “PHARMACOLOGICAL

SCREENING OF DRUG” an original practical work being submitted by – RAKESH
KALITA ; Roll no 200510011071 ; Reg no. 268805120 in partial fulfilment of the
requirement for the award of Degree of Bachelor of Pharmacy in GIRIJANADA
CHOWDHURY INSTITUTE OF PHARMACEUTICAL SCIENCE (GIPS), affiliated to
ASTU , Guwahati , Assam is a bonafied assignment which had been carried out during the
academic session 2023-24.

We wish him all success in life.

MR. RAJANA JAMES DR. BHANU PRATAP SAHU

ASSISTANT PROFESSOR PRINCIPAL
GIPS,GUWAHATI GIPS, GUWAHATI
 GIRIJANANDA CHOWDHURY INSTITUTE OF PHARMACEUTICAL SCIENCE
(GIPS)
(A Unit of Shrimanta Shankar Academy)
Approved by AICTE & PCI, New Delhi Affiliated to Assam Science & Technology
University,
N.H.37, Hatkhowapara, Azara, Guwahati – 781017
Telephone:0361-2843405,
E-mail: gipsguwahati@rediffmail.co

DECCLARATION

I hereby declare that the practice school report entitled “PHARMACOLOGICAL

SCREENING OF DRUG “is a bonafied and review work carried out by me under the
supervision of Mr. RAJANA JAMES (Assisstant Professor); Department of
Pharmacology; GIPS(Guwahati), Affiliated to ASTU, Guwahati, Assam. The work
embodied in this review work is original and has not been submitted in part or full for the
award of degree, diploma, associateship or fellowship of any other university or institution.

RAKESH KALITA
B.PHARM 7TH SEMESTER
ROLL NO : 200510011071
REG. NO : 268805120
 Acknowledgement

I would like to take this opportunity to express sense of gratitude for the guidance, assistance,
encouragement and support of Mr. RAJANA JAMES in making the project and this project
report successful which has been structured under his valued suggestion. He helped me to
accomplish the challenging task in a very short period of time. I would also like to express
my gratitude to my parents, my fellow mates and our lab assistant who have helped me to
carry out this work. Last but not the least, I thank my almighty God for his/her blessing
showed on me during this period

RAKESH KALITA
 CONTENTS

• Introduction

• Screening of drugs

• Types of screening

• Methods of screening

• Bio Assay

• Basic overview of preclinical toxicity

• Types

• Conclusion

• Reference
 INTRODUCTION

What is preclinical studies?

Preclinical trial is a laboratory test of a new drug or a series of chemicals, usually done on
animal subjects, to see if the hoped for treatment really works and if it is safe to test on
humans.

The main goals of pre-clinical studies are to determine a products ultimate safety profile.

Product may include new medical devices, drugs , gene therapy solutions etc.

Several steps in preclinical trial-

1. Identifying a drug target.

2. Develop a bioassay
3. Screen the drug in the assay
4. Establish effective and toxic doses
5. File for approval as an investigational new drug (IND)

SCREENING OF DRUGS

A thorough investigation to-

• Get pharmacological activity of new/chemically undefined substances

• Investigate the functions of endogenous mediators

• Measure/ define the toxicity and/or unwanted actions

 TYPES OF SCREENING

1. SIMPLE SCREENING :-

• One or 2 similar test to find substances having a particular property.

• To find the substance are active in single way.
• Inexpensive and less time consuming.
• Select only suitable method
• No need for battery/series of test
• Not sufficient accuracy in results.
• Example- Hypoglycaemic testing : Ability of a compound to diminish the blood
glucose levels.

2. BLIND SCREENING :-

• Only for the series of new chemical substances with no prior pharmacological history.
• New chemical entity or isolated naturals.
• Provides a road towards the fields of activity if they exist.
• Point out the most potent chemical with interesting pharmacological activity.
• Requires planning and skilful execution of test.
• To demonstrate whether new groups of substances is worthy for further attention.
3. PROGRAMMED SCREENING :-

• Provide information “ what compounds are active in what way?”

• A series of testing program is required to provide information on the compounds on
specific target.
 • Explores main activity and subsidiary activity.
• More limited then blind screening, precision is expected

METHODS OF SCREENING

1. In-vitro
2. Ex-vivo
3. In-vivo
4. Insilico

IN-VITRO-

It is an experimental process in a given procedure which is mainly done outside the body in a
controlled condition.
 Activity assays ( screen the activity)
 Bio assays ( defines the molecular mechanism)
 Toxicity assays ( toxicity of chemicals)

Types-
 Biological assay using isolated tissues/organs
 Chemical assay using reagent :
1. Antioxidant assays
2. Xanthine oxidase activity
3. Antiglycation activity
4. DNA, Protein, RNA level assays
5. Immunological assays
 Cell culture studies :
1. Toxicity assay
2. Immunological assay
3. Cancer cell line studies

EX-VIVO-

It is an experimental process which is performed outside the living body in an artificial in-
vivo environment.

It usually lasts up to 24 hours.

IN-VIVO-

It is an experimental process which is performed in the living body using laboratory animals.

INSILICO-
It is a process which is performed on computer or via computer simulator.

BIO-ASSAY (BIOLOGICAL SCREENING)

The techniques employed for the determination of the potency of chemical and biological
agents like drugs, hormones, ions, etc., by means of biological indicators using whole
animals, isolated organs and tissues or using cell lines.

Biological indicators:
 Body temperature
 Blood glucose level
 Behavioural responses
 Serum parameters
 Contraction/relaxation
 Growth/ inhibition of cells

Factors :

1. Species
2. Strains
3. Sex
4. Age
5. Disease
6. Induction
7. Environmental

BASIC OVERVIEW OF PRECLINICAL TOXICOLOGY

What is toxicology?

Toxicology is the study of the adverse/unwanted effects of chemical, physical, or biological

agents on people, animals and the environment.

Why should we do toxicology testing?

We do this to prove that the new drugs are safe-

1) before the administration to humans
2) before later clinical trials.

TYPES OF TOXICOLOGY

1. In-vitro toxicology-
  Provide information on mechanism of action of a drug.
 Provides an early indication of the potential for some kind of toxic effects, allowing a
decision to terminate or to proceed further.

Uses-

 Screening and ranking chemicals

 Studying cells, tissues, or target specific effects.

2. In-vivo toxicology-

 Establish a safe starting dose for clinical studies.

 To determine the dose levels for future prospects.
 Assess target organ toxicity and its reversibility.

CONCLUSION :

The conclusion of a PHARMACOLOGICAL SCREENING OF DRUGS typically involves

summarizing the observed effects , efficacy , safety and potential side effects. It may also
address whether the drug shows promise for further development or requires additional
research.

REFERENCE

 Rao Muralidhar, Screening Methods in Pharmacology, Volume 1- Principles and

Applications
 Source: www.google.com
www.slideshare.net