investigational new drug application

Presented by:-
Shivshankar k Chandapure
M Pharm Pharmaceutics

INTRODUCTION
An IND is a submission to the food and drug administration
(FDA) requesting permission to initiate a clinical study of a
new drug product.
 The Federal Food , Drug and Cosmetic act requires that drugs
have an approved marketing application before they can be
shipped in interstate commerce.
The IND application allows a company to initiate and conduct
clinical studies for their new drug products.
The IND application provides the FDA with the data necessary
to decide whether the new drug and the proposed clinical trial
pose a reasonable risk to the human subjects participating in
the study

WHAT IS AN IND ?
FDA's role in the development of a new drug begins when the
drug's sponsor has screened the new molecule for
pharmacological activity and acute toxicity potential in
animals, wants to test its diagnostic or therapeutic potential in
humans.
The molecule changes in legal status under the Federal Food,
Drug, and Cosmetic Act and becomes a new drug subject to
specific requirements of the drug regulatory system.
Drug is to be the subjected to an approved marketing
application before it is transported or distributed across state
lines .
IND- notice of claimed investigational exemption for a new
drug must be filed with regulatory body.

IMPORTANCE OF INDA
An IND is required any time I want to conduct a clinical
trial of an unapproved drug.
An IND would be required to conduct a clinical trail if the
drug is a new chemical entity , not approved for the
indication under investigation in a new dosage form.
Being administered at a new dosage level.
 in combination with another drug and the combination is
not approved.
 All clinical studies where a new drug is administered to
human subjects , regardless of whether the drug will be
commercially developed , require an IND.

WHEN YOU DON’T NEED AN IND
An IND is not required to conduct a study if the drug :
It is not intended for human subjects , but is intended for
in vivo testing or lab research animals (non clinical
studies).
It is an approved drug and the study is within its approved
indication for use.

TYPES OF IND
 Investigator IND
 Submitted by a physician who both initiates and conducts an investigation, and
under whose immediate direction the investigational drug is administered or
dispensed.
 Physician might submit a research IND to propose studying an unapproved
drug, or an approved product for a new indication or in a new patient population
 Emergency Use IND
 Allows FDA to authorize use of an experimental drug in an emergency situation
 Does not allow time for submission of an IND in accordance with 21CFR , Sec.
312.23 or Sec. 312.34
 Treatment IND
 Submitted for experimental drugs showing promise in clinical testing for
serious or immediately life-threatening conditions while the final clinical work is
conducted and the FDA review takes place

CLASSIFICATION OF IND
 Commercial
 Permits sponsor to collect data on clinical safety and
effectiveness needed for application for marketing in the form
of NDA.
Research (non-commercial)
 Permits the sponsor to use drug in research to obtain
advanced scientific knowledge of new drug
 No plan to market the product

CONTENT OF IND
 In three broad areas:
 Animal Pharmacology and Toxicology Studies –
 An assessment as to whether the product is reasonably safe for initial testing in humans o Any
previous experience with the drug in humans
 Manufacturing Information
 composition, manufacturer, stability, and controls used for manufacturing the drug
 Clinical Protocols and Investigator Information
 Commitments to obtain informed consent from the research subjects, to obtain review of the study
by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
 Once the IND is submitted, the sponsor must wait 30 days before initiating any clinical trials.
During this time, FDA has an opportunity to review the IND for safety to assure that research
subjects will not be subjected to unreasonable risk

RESOURCES FOR IND APPLICATIONS
Pre-IND Consultation Program
CDER's Pre-Investigational New Drug Application (IND)
Consultation Program fosters early communications between
sponsors and new drug review divisions to provide guidance on the
data necessary to warrant IND submission. The review divisions
are organized generally along therapeutic class.
Guidance Documents for INDs
documents are prepared for FDA review staff and
applicants/sponsors to provide guidelines to the processing, content,
and evaluation/approval of applications and also to the design,
production, manufacturing, and testing of regulated products

GUIDANCE DOCUMENTS FOR THE COMPLETE LIST OF CDER GUIDANCE, PLEASE SEE THE
GUIDANCE INDEX
 Safety Reporting Requirements for INDs and BE/BA Studies
 CGMP for Phase 1 Investigational Drugs
 Exploratory IND Studies
 Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of
Drugs, Including Well Characterized, Therapeutic, Biotechnology-Derived Products
 Q & A - Content and Format of INDs for Phase 1 Studies of Drugs, Including WellCharacterized,
Therapeutic, Biotechnology-Derived Products
 Bioavailability and Bioequivalence Studies for Orally Administered Drug Products
 IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment
of Cancer
 Guideline for Drug Master Files:-
 A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may
be used to provide confidential detailed information about facilities, processes, or articles used in
the manufacturing, processing, packaging, and storing of one or more human drugs.
 Required Specifications for FDA's IND, NDA, and ANDA Drug Master File Binders
 Immunotoxicology Evaluation of Investigational New Drugs

LAWS, REGULATIONS, POLICIES, PROCEDURES
The Federal Food, Drug, and Cosmetic Act is the basic food and
drug law of the U.S The law is intended to assure consumers
that foods are pure and wholesome, safe to eat, and produced
under sanitary conditions; that drugs and devices are safe and
effective for their intended uses; that cosmetics are safe and
made from appropriate ingredients; and that all labeling and
packaging is truthful, informative, and not deceptive.

THE FOLLOWING REGULATIONS APPLY TO THE IND APPLICATION
PROCESS:
Number Regulation
21CFR Part 201 Drug Labeling
21CFR Part 312 Investigational New Drug Application
21CFR Part 314 INDA and NDA Applications for FDA Approval to Market a New
Drug (New Drug Approval)
21CFR Part 316 Orphan Drugs
21CFR Part 50 Protection of Human Subjects
21CFR Part 54 Financial Disclosure by Clinical Investigators
21CFR Part 56 Institutional Review Boards
21CFR Part 58 Good Lab Practice for Nonclinical Laboratory [Animal] Studies

investigational new drug application

REFERENCE
DRUG DISCOVERY AND CLINICAL RESEARCH - SK Guptha.
Chapter 1(new drug development)
 https://www.fda.gov/drugs/developmentapprovalprocess/howd
rugsaredevelopedandapproved/approvalapplications/investigat
ionalnewdrugindapplication/default.htm
 https://www.fda.gov/downloads/aboutfda/reportsmanualsform
s/forms/ucm083533.pdf
 https://www.fda.gov/downloads/aboutfda/reportsmanualsform
s/forms/ucm074728.pdf

The glory of medicine is that it is constantly
moving forward, that there is always more to
learn. The ills of today do not cloud the horizon of
tomorrow, but act as a spur to greater effort.
- William James Mayo

investigational new drug application

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