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S U BM ITT ED BY S U BM I TT ED TO
R A H U L PA L D R . S . BH A R ATH R ED D Y
M .P H A R M ( P H A R M A C EU TI C S) , 1 S T Y EA R
CONTENTS
INVESTIGATIONAL NEW DRUG APPLICATION (IND)
• INTRODUCTION
DO & DON’T
• TYPES OF IND STUDIES
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.
An IND is require at any time when we An IND is not required to conduct a study
want to conduct a clinical trial of an if the drug:
unapproved drug. ◦ Is not intended for human subjects, but
An IND would be required to conduct a is intended for vivo testing or lab
clinical trial if the drug is: research (non-clinical studies).
◦ A new chemically entity, not approved ◦ Is an approved drug and the study is
for the indication under investigation in within its approved indication for use.
a new dosage form.
◦ Being administered at a new dosage
level.
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.
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.
Key development provided to each Describes how the clinical trial would be
investigator and IRB at each of the clinical conducted.
site. It describes-
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.
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.