GLOBAL SUBMISSION ON IND.pptx

GLOBAL SUBMISSION ON IND
PRACHI PANDEY*
RAHUL PAL
M. PHARM (PHARMACEUTICS)
NIMS INSTITUTE OF PHARMACY, NIMS UNIVERSITY, JAIPUR, RAJASTHAN, INDIA.

CONTENTS
INVESTIGATIONAL NEW DRUG APPLICATION (IND)
• INTRODUCTION
DO & DON’T
• TYPES OF IND STUDIES
IND CONTENT AND FORMAT
• IND SUBMISSION PROCESS
QUESTIONAR

INVESTIGATIONAL NEW DRUG
APPLICATION (IND)
 An Investigational New Drug is a submission to Food and Drug Administration
(FDA) requesting permission to initiate the study of New drug products.
 The IND is also the vehicle through which a sponsor advances to the next stage of drug
development known as clinical trials (human trials).
 Investigational new drug defined under 21 CRF 312.3 (b) “as a new drug or biological
drug that is used in clinical investigation.

INTRODUCTION
Definition: “An Investigational New Drug Application (IND) is a request from a
clinical study sponsor to obtain authorization from the Food and Drug
Administration (FDA) to administer an investigational drug or biological product to
humans.”
• IND application is used to provide data showing is reasonable to begin test of a new
drug on humans.
• Sponsor investigator is means an individual who both initiate and conducts an
investigation.

WHEN DO WE NEED AS
IND
An IND is require at any time when we
want to conduct a clinical trial of an
unapproved drug.
An IND would be required to conduct a
clinical trial if the drug is:
◦ A new chemically entity, not approved
for the indication under investigation in
a new dosage form.
◦ Being administered at a new dosage
level.
WHEN DO DON’T NEED AN
IND
An IND is not required to conduct a study
if the drug:
◦ Is not intended for human subjects, but
is intended for vivo testing or lab
research (non-clinical studies).
◦ Is an approved drug and the study is
within its approved indication for use.

TYPES OF IND STUDIES
All clinical studies where a new dug is administered to human subjects, regardless of whether the drug
will be commercially developed, require an IND.
01. 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.
02. Emergency IND: All the FDA to authorize use of an experimental drug in an emergency situation.
03. Treatment IND: Is submitted for experimental drug promise in clinical testing of 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): Permit the sponsor to use drug in research to
obtain advanced scientific knowledge of new drug and plan to market the
product.

IMPORTANCE OF IND
 Helps in the result of successful preclinical development program.
 The preclinical study, helps the sponsor’s primary goal to determine that the products
is reasonably safe for initiate use in human.
 It is important for the company to initiate and conduct the clinical studies of their new
product.
 It secure the safety and effectiveness of the clinical trials subjects.
 IND can be alternative in a life threatening situation when no standard acceptable
therapy is available.

IND CONTENT & FORMAT
 Cover sheet (FORM FDA 1571)
 Table of contents.
 Introductory statement and general investigational plan.
 Investigator's brochure.
 Protocols.
 Chemistry, Manufacturing and Control information (CMC).
 Pharmacology and toxicology information.
 Previous human experience with the investigational drug.
 Other relevant information like no of IND submission, no. of copies to be submitted (1+2)
 Protocol amendments, any changes in the protocol.

TABLE OF CONTENT
Table of content-
• Comprehensive listing of contents of IND
application broken in volumes and page
number.
TOC include- Sections, appendices,
attachments, repots and other reference
material.
A well drafted TOC will facilitate the task
of review and decrease the review time.
GENERAL INVESTIGATIONAL
PLAN
A brief 3 to 4 pages notes on-
- The investigational products
- Sponsors investigational plan.
Goal of the section is to-
◦ To provide brief description of the
drug.
◦ Layout development plan of the
drug.

INVESTIGATORS BROCHURE
 Key development provided to each
investigator and IRB at each of the clinical
site.
◦ Includes- All about the investigational drug.
 IB is a living documents and must be
updated by the sponsor.
PROTOCOLS
 Describes how the clinical trial would be
conducted.
It describes-
- The objectives of the study.
- How subjects would be selected.
- How the trial is to be conducted.

IND SUBMISSION PROCESS
All Collected data should be submitted in triplicate to the FDA alongside three
supplementary forms.
◦ The FDA then has 30 days to review and approve your product. In the case of
approval, or simply a lack of rejection in the 30-day timeframe, your product has
the green light to progress to the clinical testing stage and may be transported to
clinical investigators in different states.

https://www.ideagen.com

How long does it take to get IND
approval?
- After submission of IND to the FDA, it is assigned to the various divisions of
Centre for Drug Research and Evaluation wing of the FDA for its review and
evaluation.
- Once the IND is submitted, the sponsor must wait 30 calendar 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.

WHO GAVE APPROVAL FOR IND?
The office of DCG (I) grants approval of manufacture / import of new drugs for
marketing in the country. This office is also responsible for grant of permission to
conduct clinical trials of new drugs including Investigational New Drugs (IND).

What comes first IND or NDA ?
The difference between IND and NDA
- It starts with an IND submission (after the pre-clinical activities are settled to
gain approval to cross state lines and start clinical trials) and ends with the NDA
submission to ensure all aspects of the drug are effective and ready to market in the USA.

GLOBAL SUBMISSION ON IND.pptx

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