process of discovery of a new drug what are clinical trials why clinical trials are conducted overview of phases in a clinical trial details about every phase focus and purpose of conducting clinical trial

1. DRUG DEVELOPMENT
PROCESS

2. Discovery of
New Drug
• Research for a new drug begins in the
laboratory.
• Many tests of molecular compounds to
find possible beneficial effects against any
of a large number of diseases.

3. Development of the Drug
 Once researchers identify a promising compound for development, they conduct experiments to
gather information, which are called as Clinical Trials.

4. What are clinical trials?
 Clinical Trials are a way to test new
methods of diagnosing, treating, or
preventing health conditions.
 The goal is to determine whether
something is both safe and effective.
 A variety of things are evaluated through
clinical trials, including medical devices,
Medications, medication combinations,
new uses for existing medications.

5. Why Clinical Trials Are Conducted.
 To find out How it is absorbed, distributed, metabolized, and excreted.
 Side effects or adverse events that can often be referred to as toxicity.
 Its potential benefits and mechanisms of action.
 Its effectiveness as compared with similar drugs.
 The best dosage.
 How it affects different groups of people (such as by gender, race, or
ethnicity) differently.
 How it interacts with other drugs and treatments.

6. Pre-Clinical Research
 Before doing a clinical trial, investigators
conduct preclinical research using human
cell cultures or animal models.
 Usually, preclinical studies are not very
large.
 However, these studies must provide
detailed information on dosing and
toxicity levels.
 After preclinical testing, researchers
review their findings and decide whether
the drug should be tested in people.

7. Phase 0
 It is done with a very small number of
people, usually fewer than 15.
 Investigators use a very small dose of
medication to make sure it isn’t harmful to
humans.
 If the medication acts differently than
expected, the investigators will likely to do
some additional preclinical research before
deciding whether to continue the trial.

8. Phase-I
 In Phase-I about 20 to 80 people
participate who have no underlying health
conditions.
 This phase aims to figure out the highest
dose humans can take without serious
side effects.
 investigators spend several months
looking at the effects of the medication.
 investigators also look at the best way to
administer the drug, such as orally or by
injections.

9. Phase-II
 Phase II of a clinical trial involves several
hundred participants who are living with
the condition that the new medication is
meant to treat.
 They’re usually given the same dose that
was found to be safe in the previous
phase.
 Investigators monitor participants for
several months or years to see how
effective the medication is and to gather
more information about any side effects it
might cause.

10. Phase-III
 Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the
new medication is meant to treat.
 Trials in this phase can last for several years.
 The purpose of phase III is to evaluate how the new medication works in comparison to existing
medications for the same condition.
 To move forward with the trial, investigators need to demonstrate that the medication is at least as
safe and effective as existing treatment options.
 To do this, investigators use a process called randomization. This involves randomly choosing
some participants to receive the new medication and others to receive an existing medication.P
 Phase III trials are usually double-blind, which means that neither the participant nor the
investigator knows which medication the participant is taking. This helps to eliminate bias when
interpreting results.se-II

11. Approval of Drug by FDA
 If a drug developer has evidence from its
early tests and preclinical and clinical
research that a drug is safe and effective
for its intended use, the company can file
an application to market the drug.
 The FDA review team thoroughly
examines all submitted data on the drug
and makes a decision to approve or not to
approve it.

12. Phase-IV
 Phase IV clinical trials happen after the
FDA has approved medication.
 This phase involves thousands of
participants and can last for many years.
 Investigators use this phase to get more
information about the medication’s long-
term safety, effectiveness, and any other
benefits.

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