Preclinical studies

In the slideshare i have discussed about principal of preclinical studies
various approaches towards preclinical studies
a route map of preclinical trials and its various 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:- IDENTIFY A DRUG TARGET DEVELOP A BIO-ASSAY SCREEN THE DRUG IN THE ASSAY ESTABLISH THE EFFECTIVE AND TOXIC DOSE FILE FOR APPROVAL AS AN IND

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