The drug development process involves 5 main steps: (1) discovery and development through preclinical research on animals, (2) clinical research conducted in 4 phases with human subjects to test safety, efficacy, and side effects, (3) FDA drug review of the New Drug Application and clinical trial data, (4) potential FDA approval or denial, and (5) ongoing FDA post-market drug safety monitoring through manufacturer inspections, surveillance of large electronic health databases, and analysis of reported adverse events. The overall process aims to discover new drugs, understand how they work, ensure they are safe and effective for their intended use through clinical trials, and continuously monitor approved drugs for unexpected safety issues.

1. Step 1:
Discovery &
Development
Step 2:
Preclinical
Research
Step 3:
Clinical
Research
Step 4:
FDA
Drug Review
Step 5:
FDA Post-
Market Drug
Safety
Monitoring
The Drug Development Process

2. Discovery: Everything starts with an idea > years of research > discovery of molecule.
Development : To discover more about the drug i.e. mechanism of action , drug dose , toxicity
study and best way to give drug.

3. Step 2: Preclinical Research
Aim : To test the new drug on non-human subjects for
Pharmacokinetic (PK) Study
*what does body do to the drug?
(ADME)Absorption, Distribution, Disposition, Metabolism,
& Excretion is a PK process of measuring the ways the new
drug affects the body.ADME studies is primarily assessed
to analyze the bioavailability(Bioavailability of drugs is the
concentration of the drug compound that reaches the
systemic circulation or the site of action.) of the drug at the
site of action.Once absorbed, the drug compound is
required to reach the site of action. From the bloodstream,
the most common distribution medium, the drug
compound reaches various organs and muscles.Most small
molecules transform into metabolites through metabolic
breakdown involving specific enzymatic systems.The body
excretes metabolites and remaining drugs through the
kidneys and other organs. If excretion is incomplete, the
accumulation of foreign substances in the body can
adversely influence various metabolic processes.
Pharmacodynamic studies
*what does drug do to the body
Pharmacodynamics, with Pharmacokinetics , helps explain the relationship
between the dose and response, ie, the drug's effects
To check efficacy of a drug
Toxicity study
The ADME studies often include toxicity study as the last
phase. It calculates the extent to which the administration of a
drug compound can harm the human body or organisms.
Two types of preclinical research are:
In vivo: when research or work is done with or
within an entire, living organism (animals )
In vitro: Testing examines the drug molecules’
interactions within a controlled environment, such
as a test tube or petri dish.

4. Drug developers, or sponsors, must submit an Investigational
New Drug (IND) application to FDA before beginning clinical
research. In the IND application, developers must include:
 Animal study data and toxicity (side effects that cause
great harm) data
 Manufacturing information
 Clinical protocols (study plans) for studies to be
conducted
 Data from any prior human research
 Information about the investigator
Includes 4 Phases :
Phase I >( purpose : safety and doses i.e. maximum tolarable dose )
Phase II>(purpose : efficacy and side effects) unicentric enrollment of
patients(involving a few hundred patient max.200)
Phase III>(efficacy and monitoring adverse reaction ) multicentric enrollment of
patients( involve 300 to 3,000 participants.)
Phase IV>(safety and efficacy) Phase 4 trials are carried out once the drug or
device has been approved by FDA during the Post-Market Safety
Monitoring.(includes long term adverse effect studies.)

5. Step 4: FDA(Food and Drug Administration) Drug Review
A New Drug Application (NDA) tells the full story of a
drug. Its purpose is to demonstrate that a drug is safe
and effective.
A drug developer must include everything about a
drug—from preclinical data to Phase 3 trial data—in an
NDA along with clinical results, developers must
include:
 Proposed labeling
 Safety updates
 Drug abuse information
 Patent information
 Any data from studies that may have been
conducted outside the United States
 Institutional review board compliance information
 Directions for use
FDA Review
Once FDA receives an NDA, the review team decides if it is complete then the
review team has 6 to 10 months to make a decision on whether to approve the
drug. The process includes the following:
 Each member of the review team conducts a full review of his or her
section of the application. For example, the medical officer and the
statistician review clinical data, while a pharmacologist reviews the data
from animal studies. Within each technical discipline represented on the
team, there is also a supervisory review.
 FDA inspectors travel to clinical study sites to conduct a routine
inspection. The Agency looks for evidence of fabrication, manipulation, or
withholding of data.
 The project manager assembles all individual reviews and other
documents into an “action package.” This document becomes the record
for FDA review. The review team issues a recommendation, and a senior
FDA official makes a decision.
FDA Approval
In cases where FDA determines that a drug has been shown to be safe and
effective for its intended use, it is then necessary to develop and refine
prescribing information referred to as “labeling.” Labeling accurately and
objectively describes the basis for approval.

6. Step 5: FDA Post-Market Drug Safety Monitoring
 Even though clinical trials provide important information on a drug’s efficacy and safety, it is
impossible to have complete information about the safety of a drug at the time of approval.
Therefore, the true picture of a product’s safety actually evolves over the months and even years
that make up a product’s lifetime in the marketplace.
 Manufacturer Inspections
FDA officials conduct routine inspections of drug manufacturing facilities across the
United States, and abroad if approved products are manufactured overseas.
Manufacturers may be informed of inspections in advance, or the inspections may be
unannounced. Inspections may be routine or caused by a particular problem or concern.
The purpose of these inspections is to make sure that developers are following good
manufacturer practice. FDA can shut down a facility if minimum standards are not met.
 Active Surveillance
Under the Sentinel Initiative, FDA is developing a new national system to more quickly spot
possible safety issues. The system will use very large existing electronic health databases—
like electronic health records systems, administrative and insurance claims databases, and
registries—to keep an eye on the safety of approved medical products in real time. This tool
will add to, but not replace, FDA's existing post market safety assessment tools. Learn more
about the Sentinel Initiative and its major activities.

7. THE END
PRESENTED BY
TANUMOY DAS