The document discusses the general principles of pre-clinical studies. It describes the steps involved which include identifying a drug target, developing a bioassay to test the drug, screening the drug in the assay, and establishing the effective and toxic doses. It also discusses the types of pre-clinical studies like pharmacodynamics, pharmacokinetics and toxicity studies that are required before different phases of clinical trials. The common methods of screening drugs in pre-clinical studies are in-vitro, in-vivo, ex-vivo and in-silico methods.

1. GENERAL PRINCIPLES OF
PRE-CLINICAL STUDIES
MR JAYHIND BHARTI
M PHARMACY (PHARMACOLOGY SEM-1)

2. CONTENT:-
1. Introduction
2. Steps involved in Pre-clinical trial
3. Types of Screening
4. Preclinical Studies and its methods

3. INTRODUCTION:-
Preclinical trial –
 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.
 Aimed to obtain basic information on drug’s effect that may
be used to predict safe and effective use in humans.
 Objective is to generate all data that satisfy all
requirements before a new compound is deemed fit to be
tested for the first time in humans.

4. DRUG DEVELOPMENT PROCESS

5. STEPS INVOLVED IN PRECLINICAL TRIAL:-

6. 1) STEP 1:-GET AN IDEA OF DRUG TARGET
 Drugs usually act on either cellular or genetic chemicals in the
targets, which are believed to be associated with disease.
 Scientists use a variety of techniques to identify and isolate
learn more about their functions and how they influence disease.
 Compounds are then identified that have various interactions with
targets that might be helpful in treatment of a specific disease.

7. 2) STEP TWO: DEVELOPE A BIOASSAY
 A Bioassay is a “live” system that can be used to measure drug effect.

8.  3) STEP THREE: SCREEN THE DRUG IN THE ASSAY

9.  4) STEP FOUR: ESTABLISH THE EFFECTIVE AND TOXIC DOSE
 5) STEP FIVE: FILE FOR APRROVAL AS AN IND

10. Preclinical Studies continue along with
Clinical Trials
1. Preclinical studies to be performed before phase I clinical trials
 Pharmacodynamics
 Pharmacokinetics
 Single dose toxicity in two species
 Repeated dose toxicity in two species, minimum 2 weeks.
 Local tolerance
 Teratogenicity study if fertile women are included in the study.

11. 2. Preclinical studies to be completed before phase II clinical studies.
 All genotoxicity studies
 Repeated dose toxicity
3. Documentation before phase III clinical study
 Fertility studies
 Repeated dose toxicity
 In parallel with phase II and phase III clinical studies, other toxicity
studies are completed

12. TYPES OF SCREENING
1)Simple screening
 Substance activity?
2)Blind screening
 Is there any biological activity?
3)Programmed screening
 In What ways compound acts?

13. A ROUTE MAP OF PRE-CLINICAL STUDIES

14. METHODS OF SCREENING
1. IN-VITRO METHOD
 Experimental process in a given procedure which is mainly done
outside the body in a controlled condition
 TYPES:-
A) Biological assay using isolated tissues/organs
(skeletal/smooth muscles, aorta, heart etc.,)
B) Chemical Assay using regents
Ex-Antioxidant assays
Xanthine oxidase
C) Cell culture studies

15. Continue...
2. IN-VIVO METHOD
 Experimental process which is performed in the living body using
laboratory animals
3. EX-VIVO METHOD
 Experimental process which is performed outside the living body in an
artificial invivo environment
4. INSILICO METHOD
 Process which is performed on computer or via computer simulator

16. THANK YOU

17. Mcq
1) The purpose of preclinical testing is:
a)To verify that a drug is sufficiently safe and effective to be tested in humans.✓
b)To undergo preliminary testing in healthy humans to monitor the effects of the
drug.
c)To create a basic outline for the larger scale future tests on a widespread
population.
d)To develop method of drug analysis
2)Which authority gives approval for filling an IND?
a) Indian Pharmaceutical Association (IPA)
b)Food And Drug Administration (FDA)✓
c)Drug Technical Advisory Board (DTAB)
d) Central Drug Testing Laboratory(CDTL)

18. 3)IND stands for
a)Investigational New Dosage
b)International New Drug
c)Investigational New Drug✓
d)International New Dosage
4)Which of the following areas of study is not part of preclinical trials?
a)Toxicology
b)Drug metabolism
c)Pharmacology
d)Structure-activity relationships✓
5) Which screening Method is generally performed outside the body?
a)In vivo Method
b)In vitro Method✓
c) Insilico Method
d) Invasive Method

19. 6)________ Screening method is performed on computer or via computer simulator
a)In silico ✓
b)Ex vivo
c)In Vivo
d)In vitro
7)Which of the following Is correct on the basis of Pre-clinical trials?
A) Biomedical research studies
b) Behavioral research studies
c) Studies on human subjects
d) Study based only on animals✓
8) Which one of the following is the last step of a Pre-clinical trial process?
a)Investigator selection
b)Patient recruitment
c)Statistical Analysis
d)File for approval as an IND✓

20. 9) Which type of screening method generally requires 1 or 2 steps to find
substance having a particular property?
a) Simple Screening✓
b) Blind screening
c) Programmed screeening
d)None of the above
10) The Dose at which the drug is safe as well effective helps us to
determines
a)Lethal Dose Of Drug
b) Toxic Dose
c) Starting Dose Of Drug✓