Drug Discovery and different steps involved in discovery of drug

INTRODUCTION
In medicine, drug discovery is the process by which drugs are discovered and/or designed. In the past most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipitous discovery. A new approach has been to understand how disease and infection are controlled at the molecular and physiological level and to target specific entities based on this knowledge. The process of drug discovery involves the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy. Once a compound has shown its value in these tests, it will begin the process of drug development prior to clinical trials.

1. By Dr Ayesha Naaz Assistant professor Department of homoeoapthic pharmacy D r u g D i s c o v e r y

2. INTRODUCTION Drug discovery is the process by which drugs are discovered and/or designed. In the past most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipitous discovery.

3. INTRODUCTION …. continued A ne w app roac h has been t o unde rstan d h o w di s ea s e and infection are controlled at the molecular and physiological level and to target specific entities based on this knowledge. Once a compound has shown its value in these tests, it will begin the process of drug development prior to clinical trials.

4. THERE ARE 4 STEP OF DRUG DISCOVERY Step 1: discovery and development Step 2: preclinical research Step 3: clinical research Step 4: clinical verification

5. step 1: Discovery and Development

6. Discovery • Drug discovery is the process by which new candidate medication are discovered. Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by serendiptous discovery. Development How it is absorbed, distributed, metabolized, and excreted? Potential benefits and mechanisms of action? Best dosage & the best way to administer ? Side effects andits effectiveness as compared with similar drugs? How it affects different groups of differently and interacts with other drugs and treatments??

7. FOR THE SAKE OF EXPERIMENT, I TOOK FOR SEVERAL DAYS FOUR QUENTSCHEN OF GOOD CINCHONA TWICE A DAY. MY FEET, THE TIPS OF MY FINGERS, ETC. FIRST BECAME COLD, AND I FELT TIRED AND SLEEPY; THEN MY HEART BEGAN TO BEAT, MY PULSE BECAME HARD AND QUICK. …… WITH WHICH I WAS FAMILIAR IN AGUE APPEARED ONE AFTER THE OTHER.. The words of our master in context with cinchona discovery “ “

8. STEP 2: PRECLINICAL RESEARCH

9. Preclinical Research In vivo Drug proving Animal experimentati on In Vitro

10. In vivo & in vitro

11. FDA r e qu i r e s r e s ea r c h e rs t o use good la bor at ory pr actice s (GLP), defined in medical product development regulations, for Thes e regulation s se t th e preclinical laboratory studies. minimum basic requirements for: study conduct personnel facilities equipment written protocols

12. operating procedures study reports and a system of quality assurance oversight for each study to help assure the safety of FDA- regulated product BASIC REQUIREMENTS FOR

13. Step 3: Clinical Research

14. Clinical researchers aim to advance medical knowledge by conducting studies that involve people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.

15. Phase 1 Patients: 2 to 100 Length of Study: Sev eral m onths Purpose : safety Phase 2 Patients: s everal hundred. Length of Study: mo nths to years Pur p ose: efficacy and side effect

16. Phase 3 Patients: 300 to 3,000 Length of Study: 1 to 4 years Purpose: monitoring adverse effect Phase 4 Patients: Several thousand volunteers who have the disease/condition Purpose: safety and efficacy

17. THE SOURCE OF HOMOEOPATHIC DRUGS ARE VARIABLE FOR THIS PURPOSE THE COMMITTEE HAS EXPERTS Plant sourc e Bota nist Mine r a l source Chem ist Anim a l source Nosod e and sar cod e Pharm acolog

18. P ro jec t Manag er M e d ic a l Officer s t a ti s t i cian Pharm acologi st & Pharm ak i n eti c Ch em i st M ic robi ologist REV IEW TEAM

19. Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons , including: o Pa r ticipants a r e exposed to un r easonable or significant risk. o Investigators are not qualified. o Materials for the volunteer participants are misleading. o The IND application does not include enough information about the trial’s risks.

20. STEP 4: CLINICAL VERIFICATION

21. Clinical Verification is an important milestone to develop reliable Materia Medica. A symptom that is verified clinically becomes more reliable compared to the one appeared in proving. Clinical verification in homoeopathy is not a new term for homoeopath. It was known to us since Hahnemanian times. Those medicine which gives certain symptoms during proving and same during reproving again cures those symptoms when applied clinically were given utmost value. This is called clinical verification of symptoms

22. Clinical verification in homoeopathy also aid in increasing the symptom of a drug .A drug is said to be remedy when it cures or effectively relieves symptoms of drug when used in aiding way. Clinically verified, proved and reproved symptom are given most importance

23. CONCLUSION Science can never be a stationary phase and it is applied medical science too. Drug discovery is a scientific method of finding out new drugs. It consist of various steps which are approached only after proper knowledge of it. After all we should always keep in mind our master word “ is he to gain a knowledge of the instruments adapted for the cure of the natural disease, the pathogenetic powers of the medicines ? ”

24. REFERENCES http://www.nhp.gov.in/Homeopathic-Pharamacopeia-of-India-(HPI)_mtl http://www.fda.gov/forpatients/Approvals/Drugs/ ucm405382.htm http://www.fda.gov/forpatients/Approvals/Drugs/ ucm405658.htm CFR - Code of Federal Regulations Title 21