PROJECT ABOUT CLINICAL

DRUG DEVELOPMENT
BY
BHARATWAJAN M
STUDENT FROM PRESIDENCY COLLEGE, CHENNAI
 SYNOPSIS
Introduction
meaning
Stages of drug development
Phases of drug development
Drug discovery and development- Timeline
New drug application
Common ways of development of new drugs
Acceptable toxicity
Essential clinical trial document
conclusion
INTRODUCTION

• Drug development is the process of bringing a new pharmaceutical drug to

the market once a lead component has been identified the process of drug
discovery.
• It includes the preclinical research based on microorganism and animals.
• After that the FDA for IND to initiate the clinical trials on humans.
MEANING

Clinical Development, also called Drug Development, is a blanket term used to

define the entire process of bringing a new drug or device to the market. It
includes drug discovery / product development.
STAGES OF DRUG DEVELOPMENT

• Early stage
• Middle stage
• Modern stage
PHASES OF DRUG DEVELOPMENT
STEP 1: DISCOVERY & DEVELOPMENT

The first step in drug development is discovery. When new insights and
technologies become available, discovery is possible to find new treatments for
diseases. This can begin with thousands of different compounds to start with,
which will be narrowed down over time. Once the most promising compounds
are determined, the development phase can begin. During development, many
details need to be taken into consideration. This includes learning more about
what the dosage amount of a drug should be, how effective it is, and potential
side-effects, to name a few.
 STEP 2: PRECLINICAL RESEARCH

Preclinical research needs to be done before a drug can actually be given to

people, as it could have the potential to cause serious health problems. This is to
ensure that the dosage is correct, and there’s no risk of toxicity. During
preclinical research, testing can be done both in vitro and in vivo. For example,
drug testing on animals might be done during this stage before a drug can be
given to humans.
STEP:3 CLINICAL RESEARCH

When preclinical research is over, and a drug is ready to be tested on humans,

the clinical research stage of drug development begins. Clinical research is the
only way of knowing for sure how a person’s body will react to the drug.
Planning for clinical research can also require a lot of work, such as how many
people will be participating, how long testing will last, and what types of
assessments will be conducted during this stage. Anything done during the
clinical research stage must also meet FDA standards.
STEP:4 FDA REVIEW

• After preclinical and clinical research has shown that a drug is both safe and
effective, the developer can submit their research to the FDA. Of course,
getting FDA approval of a new drug is key to getting it on the market, so the
FDA review is an integral part of developing a drug.
• To have their medication reviewed, a developer needs to submit a New Drug
Application that provides detailed information about their medicine.
• This application includes all of the developer’s findings from the prior
stages. The FDA has six to 10 months to complete the review. Before
approving a new drug, the FDA may have additional questions or
require more studies. 
• Even after the FDA approves a drug, they continue to monitor its
safety. To ensure that the drug is safe on the market, they watch over
how the drug is being advertised and if any issues arise. Should
problems come up with a drug, the FDA can step in.
STEP 5: POST-MARKET MONITORING

Following drug approval and manufacturing, the FDA requires drug companies
to monitor the safety of its drug using the FDA Adverse Event Reporting
System (FAERS) database. FAERS helps FDA implement its post-marketing
safety surveillance program. Through this program, manufacturers, health
professionals, and consumers report problems with approved drugs.
NEW DRUG APPLICATION

When a drug is developed with evidence throughout its history of research to

show it is safe and effective for the intended use in the United States, the
company can file an application – the New Drug Application (NDA) – to have
the drug commercialized and available for clinical application. NDA status
enables the FDA to examine all submitted data on the drug to reach a decision
on whether to approve or not approve the drug candidate based on its safety,
specificity of effect, and efficacy of doses.
COMMON WAYS OF DEVELOPING NEW
DRUGS

• Random Screening: It is a sort of blind hitting procedure where new

chemical entities are subjected to series of pharmacological screening
procedure to explore the different types of biological activities.
• From natural products eg. Plants and animals
• Studying disease process.
• Using computers to design new drugs.
ACCEPTABLE TOXICITY

• Now a days, extensive toxicological studies ensure that drugs causing serious
toxicity do not reach the market, unless of course the agent concerned has
potentially life saving role in treating a diseases.
• And where no other more suitable drugs are available.
SOME OF THE ESSENTIAL CLINICAL TRIAL
DOCUMENTS

• Clinical study report

• Advertisement
• Queries
• Lab reference range
• Certificate of Analysis
CONCLUSION

• The drug discovery and development process is a long and complicated process.
• Before any newly discovered drugs is placed on the market it must undergo extensive
testing.
• Each success is built on many prior failures.
• At the same time researches face great changes in understanding and applying these
advances to the treatment of disease.
• These possibilities will grow as our scientific knowledge expands and becomes
increasingly complex.
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