It's all about clinical study which is important for the drug discovery channel

1. Clinical Studies
Prepared By : Fodse Sanika Dashrath
Class : Final Year B Pharmacy
Roll no. : 21
Guide By : Dr. Abhishek Meher Sir

2. Clinical trials :
 A clinical study or clinical research involves research conducted using
human volunteers .
 Clinical studies help the researcher in better understanding of diagnosis,
treatment & prevention of health condition in safe & effective way.
 Variety of things that are evaluated through clinical studies includes –
o Novel drugs, vaccines, dietary choices & supplements
o Medication combination
o Medical devices
o Surgical procedures

3. Phases of Clinical Trials :

4. Phase-0 :
• This phase is also known as micro dosing .
• This is an exploratory phase of a clinical trial that expedite the development of a promising drug by
establishing early on whether the agent behaves in human subjects as was anticipated from
pre clinical studies.
Phase-I :
• Studies in Phase-I are carried out in small number of healthy volunteers, usually 20 to 100 with the disease or
conditions and the study requires several months.
• The purpose of studies in the phase is to identify the metabolic and pharmacological effect of the drug in humans
and to determine the side effects associated with increasing, doses and if possible to gain early evidence on
effectiveness .
• The purpose of phase I studies is to mainly determine the safety profile.
• During Phase I sufficient information about the drugs pharmacokinetic and pharmacological effect is required.
• Approximately 70% of drug tested in this stage move to the next phase.

5. Phase-II :
• Testing in this phase help to determine the common short - term side effects and risk associated
with the drug under testing.
• These studies are typically well-controlled, closely monitored, and performed on the larger group
of the patients, usually involving 22 – 300.The lengths of the study vary from several months to 2
years and approximately 33% of the drugs tested at this phase move to the next phase.
Phase-III :
• phase 3 studies are expanded, controlled, and uncontrolled trials.
• The purpose of the study and this phase is to gather additional information about the effectiveness
and monitoring of adverse reaction

6. .
• Phase 3 studies usually include several hundred to several thousand people , usually 300 to 3,000 who have the
disease or condition.
• The length of the study varies from 1 to 4 years whereas approximately 25 to 30% of the drugs move to the next
phase.
Phase-IV :
• This phase is also known as post marketing surveillance(PMS) and is carried out once the candidate drug is
approved as a drug and marketed as a medicinal product.
• This phase aims to find out the drugs safety profile in the large patient pool across the world and to establish
its safety profile.
• It is estimated that the success rate of the drugs making to market from the laboratory is very less.
• The post-launch safety monitoring helps to detect the rare or long-term adverse effects of the Drug over a large
patient population and timescale than was possible during a cleaning clinical trial.
• usually several thousand volunteers who have the decision are involved in this space of the trial

7. THANK YOU !!